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En studie for å evaluere multicancer Detection (MCD) tester og deres innvirkning på deltakerhelse og kreftscreening, Vanguard -studien

5. november 2026 oppdatert av: National Cancer Institute (NCI)

Vanguard -studien: Testing av en ny måte å screene for kreft

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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

24000

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

45 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: Biospecimen Collection

Undergo blood collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Enhet: Device Usage

Evaluation of MCD tests

Andre navn:
  • Bruk av enhet
Annen: Electronic Health Record Review

Obtain health data

Annen: Questionnaire Administration

Study specific questionnaires

Fremgangsmåte: Multi-Cancer Early Detection Test

Undergo Shield MCD test

Andre navn:
  • MCD -analyse
  • MCD -test
  • MCED -analyse
  • MCED -test
  • Multikreftdeteksjonsanalyse
  • Multi Cancer Detection Test
  • Multikreft tidlig påvisningsanalyse
  • Multikreft Tidlig deteksjonstest
  • Multikreft tidlig deteksjonsanalyse
  • 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
Fremgangsmåte: Multi-Cancer Early Detection Test

Undergo Avantect MCD test

Andre navn:
  • MCD -analyse
  • MCD -test
  • MCED -analyse
  • MCED -test
  • Multikreftdeteksjonsanalyse
  • Multi Cancer Detection Test
  • Multikreft tidlig påvisningsanalyse
  • Multikreft Tidlig deteksjonstest
  • Multikreft tidlig deteksjonsanalyse
  • 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
Eksperimentell: 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.
Fremgangsmåte: Biospecimen Collection

Undergo blood collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Enhet: Device Usage

Evaluation of MCD tests

Andre navn:
  • Bruk av enhet
Annen: Electronic Health Record Review

Obtain health data

Annen: Questionnaire Administration

Study specific questionnaires

Fremgangsmåte: Multi-Cancer Early Detection Test

Undergo Shield MCD test

Andre navn:
  • MCD -analyse
  • MCD -test
  • MCED -analyse
  • MCED -test
  • Multikreftdeteksjonsanalyse
  • Multi Cancer Detection Test
  • Multikreft tidlig påvisningsanalyse
  • Multikreft Tidlig deteksjonstest
  • Multikreft tidlig deteksjonsanalyse
  • 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
Fremgangsmåte: Multi-Cancer Early Detection Test

Undergo Avantect MCD test

Andre navn:
  • MCD -analyse
  • MCD -test
  • MCED -analyse
  • MCED -test
  • Multikreftdeteksjonsanalyse
  • Multi Cancer Detection Test
  • Multikreft tidlig påvisningsanalyse
  • Multikreft Tidlig deteksjonstest
  • Multikreft tidlig deteksjonsanalyse
  • 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
Aktiv komparator: Arm III (Control)

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

Undergo blood collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Annen: Electronic Health Record Review

Obtain health data

Annen: Questionnaire Administration

Study specific questionnaires

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility of enrollment onto study
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Impact of participant blinding
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 3 years

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

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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cancer stage
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 12 years

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

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

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Scott D Ramsey, Fred Hutchinson Cancer Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

18. juni 2025

Primær fullføring (Antatt)

31. januar 2029

Studiet fullført (Antatt)

30. juni 2029

Datoer for studieregistrering

Først innsendt

29. mai 2025

Først innsendt som oppfylte QC-kriteriene

29. mai 2025

Først lagt ut (Faktiske)

30. mai 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NCI-2024-10793
  • P30CA015704 (U.S. NIH-stipend/kontrakt)
  • NCI-2024-10793 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • CSRN1 (Annen identifikator: CTEP)
  • UG1CA286954 (U.S. NIH-stipend/kontrakt)
  • CSRN1 (Annen identifikator: Fred Hutchinson Cancer Center)
  • CSRN1 (Annen identifikator: DCP)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere