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Une étude pour évaluer les tests de détection multicancière (MCD) et leur impact sur la santé des participants et le dépistage du cancer, l'étude Vanguard

5 novembre 2026 mis à jour par: National Cancer Institute (NCI)

L'étude Vanguard: tester une nouvelle façon de dépister le cancer

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).

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

24000

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

45 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Dépistage
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Procédure: Biospecimen Collection

Undergo blood collection

Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Dispositif: Device Usage

Evaluation of MCD tests

Autres noms:
  • Utilisation de l'appareil
Autre: Electronic Health Record Review

Obtain health data

Autre: Questionnaire Administration

Study specific questionnaires

Procédure: Multi-Cancer Early Detection Test

Undergo Shield MCD test

Autres noms:
  • Test MCD
  • Essai MCED
  • Test de mced
  • Test de détection de cancer multiples
  • Dosage de détection précoce multi-cancer
  • Test de détection précoce multi-cancer
  • Test de détection multi-cancer
  • Dosage de détection précoce multi-cancérants
  • 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
Procédure: Multi-Cancer Early Detection Test

Undergo Avantect MCD test

Autres noms:
  • Test MCD
  • Essai MCED
  • Test de mced
  • Test de détection de cancer multiples
  • Dosage de détection précoce multi-cancer
  • Test de détection précoce multi-cancer
  • Test de détection multi-cancer
  • Dosage de détection précoce multi-cancérants
  • 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
Expérimental: 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.
Procédure: Biospecimen Collection

Undergo blood collection

Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Dispositif: Device Usage

Evaluation of MCD tests

Autres noms:
  • Utilisation de l'appareil
Autre: Electronic Health Record Review

Obtain health data

Autre: Questionnaire Administration

Study specific questionnaires

Procédure: Multi-Cancer Early Detection Test

Undergo Shield MCD test

Autres noms:
  • Test MCD
  • Essai MCED
  • Test de mced
  • Test de détection de cancer multiples
  • Dosage de détection précoce multi-cancer
  • Test de détection précoce multi-cancer
  • Test de détection multi-cancer
  • Dosage de détection précoce multi-cancérants
  • 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
Procédure: Multi-Cancer Early Detection Test

Undergo Avantect MCD test

Autres noms:
  • Test MCD
  • Essai MCED
  • Test de mced
  • Test de détection de cancer multiples
  • Dosage de détection précoce multi-cancer
  • Test de détection précoce multi-cancer
  • Test de détection multi-cancer
  • Dosage de détection précoce multi-cancérants
  • 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
Comparateur actif: Arm III (Control)

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

Undergo blood collection

Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Autre: Electronic Health Record Review

Obtain health data

Autre: Questionnaire Administration

Study specific questionnaires

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Feasibility of enrollment onto study
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Impact of participant blinding
Délai: 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
Délai: 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
Délai: 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
Délai: Up to 3 years

Estimated as the number of participants receiving MCD testing outside the trial.
Up to 3 years
Effects of participant characteristics
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 1 year

Specificity will be estimated for each MCD assay.
1 year
Test positive rates
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Cancer stage
Délai: 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
Délai: 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
Délai: 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
Délai: Up to 12 years

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

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

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Cancer Institute (NCI)

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 juin 2025

Achèvement primaire (Estimé)

31 janvier 2029

Achèvement de l'étude (Estimé)

30 juin 2029

Dates d'inscription aux études

Première soumission

29 mai 2025

Première soumission répondant aux critères de contrôle qualité

29 mai 2025

Première publication (Réel)

30 mai 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 novembre 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NCI-2024-10793
  • P30CA015704 (Subvention/contrat des NIH des États-Unis)
  • NCI-2024-10793 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • CSRN1 (Autre identifiant: CTEP)
  • UG1CA286954 (Subvention/contrat des NIH des États-Unis)
  • CSRN1 (Autre identifiant: Fred Hutchinson Cancer Center)
  • CSRN1 (Autre identifiant: DCP)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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