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Un estudio para evaluar las pruebas de detección de multicancer (MCD) y su impacto en la salud y la detección del cáncer de los participantes, el estudio de Vanguard

5 de noviembre de 2026 actualizado por: National Cancer Institute (NCI)

El estudio de Vanguard: probar una nueva forma de detectar el cáncer

The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously. There is a need to understand how MCDs may work as cancer screening tools. The goal of cancer screening is to reduce the burden of cancer by identifying cancers before they show symptoms or signs, when treatment is likely to be most effective. In this study, adults aged 45-75 without cancer will be randomly assigned to one of 3 groups: 2 separate MCD test groups or a control group. These two MCD tests will not be compared to each other but will be compared to cancers detected in the control group. This study will provide early information on how well MCD tests perform as cancer screening tools. It will also help researchers understand how patients and their doctors make decisions about their care when the MCD test result comes back as normal (negative) or abnormal (positive).

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

PRIMARY OBJECTIVES:

I. Assess the feasibility of recruitment and adherence to protocol-required baseline and follow-up data and blood collection.

II. Assess the feasibility of achieving representative enrollment across participating recruitment sites.

SECONDARY OBJECTIVES:

I. To assess the impact of participant blinding on willingness to participate, adherence to protocol required baseline and follow-up data, blood collection, and rates of standard of care screening.

II. To determine the timeliness of returning test results to participants. III. To understand the factors contributing to lack of diagnostic resolution of an abnormal MCD test.

IV. To examine the effects of participant characteristics, including cancer risk factors and social determinants of health, on all aspects of feasibility.

V. To estimate the proportion of participants receiving an MCD test outside of the trial.

VI. To assess the feasibility of a staggered introduction of the second MCD assay intervention arm.

VII. To estimate the proportion of abnormal MCD tests that are diagnostically resolved, and the time to resolution.

VIII. To compare the proportion of participants who receive standard of care screening during follow-up between the intervention and control arms.

IX. To assess the accuracy of tissue of origin prediction for each MCD assay. X. To estimate the incidence of complications related to diagnostic evaluation of an abnormal MCD test result.

XI. To assess the effect of an abnormal MCD test and diagnostic workup on anxiety and cancer worry.

XII. To evaluate the clinical diagnostic performance of the MCD assays.

EXPLORATORY OBJECTIVES:

I. To estimate rates of late-stage cancer, and the distribution of cancer stage.

II. To estimate assay-targeted cancer-specific mortality of each MCD assay, all cancer-specific mortality, and all-cause mortality.

III. To develop preliminary estimates of the total and incremental budget impact of MCD testing compared to current screening practice from the payor perspective.

IV. To develop preliminary estimates of the economic burden and impact of MCD testing from the participant perspective.

V. To assess the willingness of participants who reported military service to describe military-related environmental exposures by completing the Military Exposure Questionnaire.

OUTLINE: Participants are randomized to 1 of 3 arms.

ARM I: Participants undergo blood collection for Shield MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.

ARM II: Participants undergo blood collection for Avantect MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.

ARM III (Control): Participants undergo blood collection at enrollment and after one year on study.

After completion of study intervention, participants are followed passively up to 10 years.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

24000

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Pleasanton, California, Estados Unidos, 94588
        • Reclutamiento
        • Kaiser Permanente-Division of Research
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 510-891-3400
        • Investigador principal:
          • Jeffrey Lee
      • San Diego, California, Estados Unidos, 92134
        • Reclutamiento
        • Naval Medical Center -San Diego
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 619-532-8712
        • Investigador principal:
          • Brittany E. Powell
    • Colorado
      • Cheyenne Wells, Colorado, Estados Unidos, 80810
        • Reclutamiento
        • Keefe Memorial Hospital
        • Contacto:
        • Investigador principal:
          • Linda S. Cook
      • Denver, Colorado, Estados Unidos, 80205
        • Reclutamiento
        • Kaiser Permanente-Franklin
        • Investigador principal:
          • Debra P. Ritzwoller
        • Contacto:
      • Fort Collins, Colorado, Estados Unidos, 80524
        • Reclutamiento
        • Poudre Valley Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 970-297-6150
        • Investigador principal:
          • Linda S. Cook
      • Fort Collins, Colorado, Estados Unidos, 80528
        • Reclutamiento
        • Cancer Care and Hematology-Fort Collins
        • Contacto:
        • Investigador principal:
          • Linda S. Cook
      • Greeley, Colorado, Estados Unidos, 80631
        • Reclutamiento
        • UCHealth Greeley Hospital
        • Contacto:
        • Investigador principal:
          • Linda S. Cook
      • Lafayette, Colorado, Estados Unidos, 80026
        • Reclutamiento
        • Kaiser Permanente-Rock Creek
        • Investigador principal:
          • Debra P. Ritzwoller
        • Contacto:
      • Lone Tree, Colorado, Estados Unidos, 80124
        • Reclutamiento
        • Kaiser Permanente-Lone Tree
        • Investigador principal:
          • Debra P. Ritzwoller
        • Contacto:
      • Loveland, Colorado, Estados Unidos, 80538
        • Reclutamiento
        • Medical Center of the Rockies
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 970-203-7083
        • Investigador principal:
          • Linda S. Cook
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96819
        • Reclutamiento
        • Kaiser Permanente Moanalua Medical Center
        • Contacto:
        • Investigador principal:
          • Stacey Honda
    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20889-5600
        • Reclutamiento
        • Walter Reed National Military Medical Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 301-319-2100
        • Investigador principal:
          • Kristen Natale
    • Michigan
      • Brownstown, Michigan, Estados Unidos, 48183
        • Reclutamiento
        • Henry Ford Health Center - Brownstown
        • Investigador principal:
          • Christine Neslund-Dudas
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 313-874-5472
          • Correo electrónico: CDUDAS1@hfhs.org
      • Brownstown, Michigan, Estados Unidos, 48183
        • Reclutamiento
        • Henry Ford Cancer Institute-Downriver
        • Contacto:
        • Investigador principal:
          • Christine Neslund-Dudas
      • Chesterfield, Michigan, Estados Unidos, 48047
        • Reclutamiento
        • Henry Ford Health Center - Chesterfield
        • Investigador principal:
          • Christine Neslund-Dudas
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 313-874-5472
          • Correo electrónico: CDUDAS1@hfhs.org
      • Clinton Township, Michigan, Estados Unidos, 48038
        • Reclutamiento
        • Henry Ford Macomb Hospital-Clinton Township
        • Contacto:
        • Investigador principal:
          • Christine Neslund-Dudas
      • Dearborn, Michigan, Estados Unidos, 48126
        • Reclutamiento
        • Henry Ford Medical Center-Fairlane
        • Contacto:
        • Investigador principal:
          • Christine Neslund-Dudas
      • Detroit, Michigan, Estados Unidos, 48202
        • Reclutamiento
        • Henry Ford Hospital
        • Contacto:
        • Investigador principal:
          • Christine Neslund-Dudas
      • Detroit, Michigan, Estados Unidos, 48235
        • Reclutamiento
        • Henry Ford Medical Center - Detroit Northwest
        • Investigador principal:
          • Christine Neslund-Dudas
        • Contacto:
      • Grosse Pointe Farms, Michigan, Estados Unidos, 48236
        • Reclutamiento
        • Henry Ford Medical Center-Cottage
        • Investigador principal:
          • Christine Neslund-Dudas
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 313-916-1784
      • Livonia, Michigan, Estados Unidos, 48150
        • Reclutamiento
        • Henry Ford Medical Center - Livonia
        • Investigador principal:
          • Christine Neslund-Dudas
        • Contacto:
      • Novi, Michigan, Estados Unidos, 48377
        • Reclutamiento
        • Henry Ford Medical Center-Columbus
        • Contacto:
        • Investigador principal:
          • Christine Neslund-Dudas
      • Plymouth, Michigan, Estados Unidos, 48170
        • Reclutamiento
        • Henry Ford Medical Center - Plymouth
        • Investigador principal:
          • Christine Neslund-Dudas
        • Contacto:
      • Royal Oak, Michigan, Estados Unidos, 48067
        • Reclutamiento
        • Henry Ford Medical Center - Royal Oak
        • Investigador principal:
          • Christine Neslund-Dudas
        • Contacto:
      • Sterling Heights, Michigan, Estados Unidos, 48310
        • Reclutamiento
        • Henry Ford Medical Center
        • Contacto:
        • Investigador principal:
          • Christine Neslund-Dudas
      • Troy, Michigan, Estados Unidos, 48083
        • Reclutamiento
        • Henry Ford Medical Center - Troy
        • Investigador principal:
          • Christine Neslund-Dudas
        • Contacto:
      • West Bloomfield, Michigan, Estados Unidos, 48322
        • Reclutamiento
        • Henry Ford West Bloomfield Hospital
        • Contacto:
        • Investigador principal:
          • Christine Neslund-Dudas
      • Wyandotte, Michigan, Estados Unidos, 48192
        • Reclutamiento
        • Henry Ford Wyandotte Hospital
        • Contacto:
        • Investigador principal:
          • Christine Neslund-Dudas
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55417
        • Reclutamiento
        • Minneapolis VA Medical Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 612-467-2800
        • Investigador principal:
          • Mark A. Klein
    • Missouri
      • Kansas City, Missouri, Estados Unidos, 64111
        • Reclutamiento
        • Saint Luke's Hospital of Kansas City
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 913-948-5588
          • Correo electrónico: aroland@kccop.org
        • Investigador principal:
          • Timothy J. Pluard
      • Springfield, Missouri, Estados Unidos, 65807
        • Reclutamiento
        • CoxHealth South Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 417-269-4520
        • Investigador principal:
          • Aimee S. James
      • St Louis, Missouri, Estados Unidos, 63110
        • Reclutamiento
        • Washington University School of Medicine
        • Contacto:
        • Investigador principal:
          • Aimee S. James
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • Reclutamiento
        • UNC Lineberger Comprehensive Cancer Center
        • Contacto:
        • Investigador principal:
          • Daniel S. Reuland
      • Durham, North Carolina, Estados Unidos, 27705
        • Reclutamiento
        • Durham VA Medical Center
        • Contacto:
        • Investigador principal:
          • Scott Shofer
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44106
        • Reclutamiento
        • Louis Stokes Cleveland VA Medical Center
        • Contacto:
        • Investigador principal:
          • Charles J. Nock
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Reclutamiento
        • University of Oklahoma Health Sciences Center
        • Contacto:
        • Investigador principal:
          • Mark Doescher
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22911
        • Reclutamiento
        • Sentara Martha Jefferson Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 434-654-8400
        • Investigador principal:
          • John M. Sayles
      • Fairfax, Virginia, Estados Unidos, 22031
        • Reclutamiento
        • Inova Schar Cancer Institute
        • Investigador principal:
          • Rebecca D. Kaltman
        • Contacto:
      • Fairfax, Virginia, Estados Unidos, 22033
        • Reclutamiento
        • Inova Fair Oaks Hospital
        • Investigador principal:
          • Rebecca D. Kaltman
        • Contacto:
      • Norfolk, Virginia, Estados Unidos, 23507
        • Reclutamiento
        • Sentara Norfolk General Hospital
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 757-388-2406
        • Investigador principal:
          • John M. Sayles
      • Portsmouth, Virginia, Estados Unidos, 23708-2197
        • Reclutamiento
        • Naval Medical Center - Portsmouth
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 757-953-5939
        • Investigador principal:
          • John C. Mattingly
      • Richmond, Virginia, Estados Unidos, 23235
        • Reclutamiento
        • VCU Massey Cancer Center at Stony Point
        • Contacto:
        • Investigador principal:
          • Alexander H. Krist
      • Richmond, Virginia, Estados Unidos, 23298
        • Reclutamiento
        • VCU Massey Comprehensive Cancer Center
        • Investigador principal:
          • Alexander H. Krist
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 804-628-6430
          • Correo electrónico: CTOclinops@vcu.edu
      • South Hill, Virginia, Estados Unidos, 23970
        • Reclutamiento
        • VCU Community Memorial Health Center
        • Contacto:
        • Investigador principal:
          • Alexander H. Krist
    • Washington
      • Tacoma, Washington, Estados Unidos, 98431
        • Reclutamiento
        • Madigan Army Medical Center
        • Contacto:
        • Investigador principal:
          • Matthew Lavoie
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53295
        • Reclutamiento
        • Zablocki Veterans Administration Medical Center
        • Contacto:
          • Site Public Contact
          • Número de teléfono: 888-469-6614
        • Investigador principal:
          • Jeffrey C. Whittle

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

45 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Ages 45-75 years old

  • Agree to provide blood samples for possible MCD testing at enrollment and at 1 year following enrollment

  • Agree to allow collection of information from their medical records for study-related purposes

  • Understand and be able to complete informed consent and participant questionnaires in English, Spanish, or Arabic

    • Note: Eligibility for Spanish and Arabic languages are at the Hub's discretion

Exclusion Criteria:

  • Solid malignant tumor or blood cancer diagnosis, with or without treatment, within the last 5 years

    • Note: Persons with a history of in situ cancers (e.g., ductal carcinoma in situ of the breast, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ) or nonmelanoma skin cancer are eligible. Persons with a history of prostate cancer that has not been treated are not eligible, regardless of when the diagnosis occurred

  • Ongoing cancer diagnostic work-up

  • Ongoing participation in another study of an investigational cancer screening test or technology not currently utilized in routine clinical practice

  • Currently breastfeeding or pregnant, or planning to become pregnant in the next year

  • History of solid organ or hematopoietic transplantation at any time, or blood transfusion within the last 30 days

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Poner en pantalla
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Arm I (Shield MCD test)

Participants undergo blood collection for Shield MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
Procedimiento: Biospecimen Collection

Undergo blood collection

Otros nombres:
  • Recolección de muestras biológicas
  • Muestra biológica recolectada
  • Coleccion de especimenes
  • Recolección de muestras
Dispositivo: Device Usage

Evaluation of MCD tests

Otros nombres:
  • Uso del dispositivo
Otro: Electronic Health Record Review

Obtain health data

Otro: Questionnaire Administration

Study specific questionnaires

Procedimiento: Multi-Cancer Early Detection Test

Undergo Shield MCD test

Otros nombres:
  • Ensayo MCD
  • Prueba de MCD
  • Ensayo MCED
  • Prueba MCED
  • Ensayo de detección de cáncer múltiple
  • Prueba de detección de cáncer múltiple
  • Ensayo de detección temprana de cáncer múltiple
  • Prueba de detección temprana de cáncer múltiple
  • Ensayo de detección de múltiples cáncer
  • Ensayo de detección temprana de múltiples cáncer
  • Early detection (MSED) test
  • MSED Test
  • Multi-cancer detection (MCD) test
  • Multi-Cancer Detection Test
  • Multi-cancer early detection (MCED) test
  • Multi-cancer screening
  • Multi-cancer screening test
Procedimiento: Multi-Cancer Early Detection Test

Undergo Avantect MCD test

Otros nombres:
  • Ensayo MCD
  • Prueba de MCD
  • Ensayo MCED
  • Prueba MCED
  • Ensayo de detección de cáncer múltiple
  • Prueba de detección de cáncer múltiple
  • Ensayo de detección temprana de cáncer múltiple
  • Prueba de detección temprana de cáncer múltiple
  • Ensayo de detección de múltiples cáncer
  • Ensayo de detección temprana de múltiples cáncer
  • Early detection (MSED) test
  • MSED Test
  • Multi-cancer detection (MCD) test
  • Multi-Cancer Detection Test
  • Multi-cancer early detection (MCED) test
  • Multi-cancer screening
  • Multi-cancer screening test
Experimental: Arm II (Avantect MCD test)

Participants undergo blood collection for Avantect MCD testing at enrollment and after one year on study. Participants at unblinded sites are provided results of tests and those with abnormal results follow up with their clinician for additional testing. Participants at blinded sites are provided abnormal results and will follow up with their clinician for additional testing.
Procedimiento: Biospecimen Collection

Undergo blood collection

Otros nombres:
  • Recolección de muestras biológicas
  • Muestra biológica recolectada
  • Coleccion de especimenes
  • Recolección de muestras
Dispositivo: Device Usage

Evaluation of MCD tests

Otros nombres:
  • Uso del dispositivo
Otro: Electronic Health Record Review

Obtain health data

Otro: Questionnaire Administration

Study specific questionnaires

Procedimiento: Multi-Cancer Early Detection Test

Undergo Shield MCD test

Otros nombres:
  • Ensayo MCD
  • Prueba de MCD
  • Ensayo MCED
  • Prueba MCED
  • Ensayo de detección de cáncer múltiple
  • Prueba de detección de cáncer múltiple
  • Ensayo de detección temprana de cáncer múltiple
  • Prueba de detección temprana de cáncer múltiple
  • Ensayo de detección de múltiples cáncer
  • Ensayo de detección temprana de múltiples cáncer
  • Early detection (MSED) test
  • MSED Test
  • Multi-cancer detection (MCD) test
  • Multi-Cancer Detection Test
  • Multi-cancer early detection (MCED) test
  • Multi-cancer screening
  • Multi-cancer screening test
Procedimiento: Multi-Cancer Early Detection Test

Undergo Avantect MCD test

Otros nombres:
  • Ensayo MCD
  • Prueba de MCD
  • Ensayo MCED
  • Prueba MCED
  • Ensayo de detección de cáncer múltiple
  • Prueba de detección de cáncer múltiple
  • Ensayo de detección temprana de cáncer múltiple
  • Prueba de detección temprana de cáncer múltiple
  • Ensayo de detección de múltiples cáncer
  • Ensayo de detección temprana de múltiples cáncer
  • Early detection (MSED) test
  • MSED Test
  • Multi-cancer detection (MCD) test
  • Multi-Cancer Detection Test
  • Multi-cancer early detection (MCED) test
  • Multi-cancer screening
  • Multi-cancer screening test
Comparador activo: Arm III (Control)

Participants undergo blood collection at enrollment and after one year on study.
Procedimiento: Biospecimen Collection

Undergo blood collection

Otros nombres:
  • Recolección de muestras biológicas
  • Muestra biológica recolectada
  • Coleccion de especimenes
  • Recolección de muestras
Otro: Electronic Health Record Review

Obtain health data

Otro: Questionnaire Administration

Study specific questionnaires

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility of enrollment onto study
Periodo de tiempo: At time of randomization

The number of participants enrolled into the study compared to trial goals.
At time of randomization
Proportion of participants who complete baseline and follow-up questionnaires within 60 days of receipt
Periodo de tiempo: Up to 3 years

The proportion of participants who are complete questionnaires and timing of completion.
Up to 3 years
Proportion of participants who provide the required blood sample for year 1 for Multi-Cancer Detection (MCD) testing within 90 days of recommended time point
Periodo de tiempo: Up to 2 years

The proportion of participants who have a second blood draw and the timing of the blood draw.
Up to 2 years
Proportion of participants considered lost to follow-up within 2 years of randomization
Periodo de tiempo: Up to 2 years

The proportion of participants who do not complete study procedures and are not able to be contacted.
Up to 2 years
Representative enrollment
Periodo de tiempo: Up to 2 years

Meeting or exceeding the trial enrollment goals on a population basis.
Up to 2 years
Staggered start of intervention arm 2
Periodo de tiempo: Up to 1 year

Advantages and challenges arising from trial activation with one intervention arm and later addition of a second intervention arm.
Up to 1 year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Impact of participant blinding
Periodo de tiempo: Up to 2 years

Comparisons between blinded and unblinded sites on participation rates, adherence to protocol-required questionnaires and blood collection, and participation in standard of care screening.
Up to 2 years
Timely return of MCD test result
Periodo de tiempo: Up to 2 years

The time from receipt of the MCD test result at the Statistics and Data Management Center to the time of receipt of the MCD test result at the ACCESS Hub. The time from receipt of MCD test result at the ACCESS Hub to the time of participant receipt of the MCD test result.
Up to 2 years
Factors contributing to lack of diagnostic resolution of an abnormal MCD test
Periodo de tiempo: Up to 2 years

Factors that contribute to the inability to determine if a participant has a cancer or rule out cancer.
Up to 2 years
Contamination
Periodo de tiempo: Up to 3 years

Estimated as the number of participants receiving MCD testing outside the trial.
Up to 3 years
Effects of participant characteristics
Periodo de tiempo: Up to 2 years

Feasibility outcomes will be reported by participant demographics and cancer risk factors.
Up to 2 years
Participation in standard of care screening
Periodo de tiempo: Up to 2 years

The proportion of participants that receive standard of care cancer screening in each arm.
Up to 2 years
Accuracy of tissue of origin prediction
Periodo de tiempo: Up to 2 years

The proportion of diagnosed cancers that match the tissue of origin predicted by an abnormal (positive) MCD test, for each screening episode.
Up to 2 years
Complications related to diagnostic evaluation of an abnormal MCD test result
Periodo de tiempo: Up to 1 year

Adverse events occurring in participants undergoing a diagnostic workup following receipt of an abnormal MCD test result.
Up to 1 year
Anxiety and Cancer Worry Questionnaire
Periodo de tiempo: Up to 2 years

Participant anxiety will be assessed with the Patient Reported Outcomes Measurement Information System instrument. Cancer-related worry will be assessed using the Lehrman Cancer Worry Scale.
Up to 2 years
Sensitivity of clinical diagnostic performance of each MCD assay
Periodo de tiempo: Up to 2 years

Sensitivity will be estimated for each MCD assay. These sensitivities will also be calculated by early- versus late-stage, and for MCD test-targeted cancers and all cancers.
Up to 2 years
Specificity of each MCD assay
Periodo de tiempo: 1 year

Specificity will be estimated for each MCD assay.
1 year
Test positive rates
Periodo de tiempo: Up to 2 years

The proportion of abnormal MCD tests at each screening episode, and the proportion of participants with at least one abnormal test.
Up to 2 years
False positives
Periodo de tiempo: Up to 2 years

The number of participants with an abnormal MCD test and no cancer diagnosis.
Up to 2 years
(Targeted cancer) Positive predictive value (PPV)
Periodo de tiempo: Up to 2 years

The proportion of abnormal MCD tests that result in diagnosis of one of the MCD test-targeted cancers among participants with at least one abnormal test, for each screening episode.
Up to 2 years
(All cancer) PPV
Periodo de tiempo: Up to 2 years

The proportion of abnormal MCD tests that result in diagnosis of any cancer among participants with at least one abnormal test, for each screening episode.
Up to 2 years
Interval cancers
Periodo de tiempo: 1 year

The number of MCD test-targeted cancer cases diagnosed within 12 months of a normal MCD test result among participants who received an MCD test, for each screening episode.
1 year
Detected cancers
Periodo de tiempo: 1 year

The number of cancer cases diagnosed within a 12-month follow-up period of an abnormal test result among participants who received an MCD test, for each screening episode.
1 year
(Targeted cancer) Negative predictive value
Periodo de tiempo: 1 year

The proportion of normal MCD tests that did not result in diagnosis of one of the MCD test-targeted cancers among participants with a normal test, for each screening episode.
1 year
Time to diagnostic resolution
Periodo de tiempo: From date of Hub receipt of abnormal MCD test result to date of provider-reported diagnostic resolution (Cancer diagnosis or No cancer diagnosis), up to 12 months
From date of Hub receipt of abnormal MCD test result to date of provider-reported diagnostic resolution (Cancer diagnosis or No cancer diagnosis), up to 12 months
Diagnostic resolution following an abnormal MCD test result
Periodo de tiempo: Up to 12 years

The proportion of participants with a "Cancer diagnosis" or "No cancer diagnosis" among all participants with an abnormal MCD test result will be reported for each MCD test. The fraction of "Unresolved" will also be reported.
Up to 12 years

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Cancer stage
Periodo de tiempo: Up to 12 years

The stage that a cancer was diagnosed (Surveillance, Epidemiology, and End Results [SEER]).
Up to 12 years
Early and late stages cancer diagnosis
Periodo de tiempo: Up to 12 years

Counts of early and late-stage cancers by arm, separately for each cancer type. Early stage is defined as in situ or localized (SEER). Late stage is defined as regional or distant stage (SEER).
Up to 12 years
Targeted cancer-specific mortality of each MCD assay
Periodo de tiempo: Up to 12 years

The fraction of MCD-targeted cancers diagnosed during trial participation that resulted in death.
Up to 12 years
Cancer-specific mortality
Periodo de tiempo: Up to 12 years

The fraction of all cancers diagnosed during trial participation that resulted in death.
Up to 12 years
All-cause mortality
Periodo de tiempo: Up to 12 years

The probability of participant death by any cause during trial participation, by arm.
Up to 12 years
Participant work loss
Periodo de tiempo: Up to 2 years

Participant and caregiver time spent away from work will be estimated using an adapted version of the Productivity Cost Questionnaire. The dollar value of hours recorded for participant work loss and caregiver time will be estimated using wages from the Bureau of Labor Statistics.
Up to 2 years
Proportion of participants who complete the Military Exposure Questionnaire
Periodo de tiempo: At baseline

Will evaluate the proportion of participants who complete the Military Exposure Questionnaire, among those who reported military service.
At baseline
Participant out of pocket costs
Periodo de tiempo: Up to 2 years

Direct non-medical participant costs; for example, transportation costs, travel time and distance, accommodation costs, childcare or elder-care costs will be elicited through an adapted version of the Costs for Patients Questionnaire. Direct medical care costs paid by participants (e.g., copays, deductible and uncovered medical bills) will be estimated using Medicare reimbursement and coinsurance rates for services received (Medicare Parts A-D).
Up to 2 years
Estimated costs associated with MCD testing minus estimated costs associated with standard of care screening
Periodo de tiempo: Up to 12 years

Will estimate average screening costs associated with MCD testing.
Up to 12 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Scott D Ramsey, Fred Hutchinson Cancer Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

18 de junio de 2025

Finalización primaria (Estimado)

31 de enero de 2029

Finalización del estudio (Estimado)

30 de junio de 2029

Fechas de registro del estudio

Enviado por primera vez

29 de mayo de 2025

Primero enviado que cumplió con los criterios de control de calidad

29 de mayo de 2025

Publicado por primera vez (Actual)

30 de mayo de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de noviembre de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NCI-2024-10793
  • P30CA015704 (Subvención/contrato del NIH de EE. UU.)
  • NCI-2024-10793 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • CSRN1 (Otro identificador: CTEP)
  • UG1CA286954 (Subvención/contrato del NIH de EE. UU.)
  • CSRN1 (Otro identificador: Fred Hutchinson Cancer Center)
  • CSRN1 (Otro identificador: DCP)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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