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En studie för att utvärdera multicancerdetekteringstester (MCD) och deras inverkan på deltagarnas hälsa och cancer screening, The Vanguard Study

5 november 2026 uppdaterad av: National Cancer Institute (NCI)

Vanguard -studien: Testa ett nytt sätt att screena för 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).

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

24000

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

45 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Undersökning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Procedur: Biospecimen Collection

Undergo blood collection

Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
  • Provuppsamling
Enhet: Device Usage

Evaluation of MCD tests

Andra namn:
  • Enhetsanvändning
Övrig: Electronic Health Record Review

Obtain health data

Övrig: Questionnaire Administration

Study specific questionnaires

Procedur: Multi-Cancer Early Detection Test

Undergo Shield MCD test

Andra namn:
  • MCD -analys
  • MCD -test
  • MCED -analys
  • MCED -test
  • Analys av flera cancerdetektering
  • Multicancerupptäckningstest
  • Multicancer tidig detektionsanalys
  • Multicancer tidig detektionstest
  • Multi-cancerdetekteringsanalys
  • Multi-cancer tidig detektionsanalys
  • 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
Procedur: Multi-Cancer Early Detection Test

Undergo Avantect MCD test

Andra namn:
  • MCD -analys
  • MCD -test
  • MCED -analys
  • MCED -test
  • Analys av flera cancerdetektering
  • Multicancerupptäckningstest
  • Multicancer tidig detektionsanalys
  • Multicancer tidig detektionstest
  • Multi-cancerdetekteringsanalys
  • Multi-cancer tidig detektionsanalys
  • 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
Experimentell: 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.
Procedur: Biospecimen Collection

Undergo blood collection

Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
  • Provuppsamling
Enhet: Device Usage

Evaluation of MCD tests

Andra namn:
  • Enhetsanvändning
Övrig: Electronic Health Record Review

Obtain health data

Övrig: Questionnaire Administration

Study specific questionnaires

Procedur: Multi-Cancer Early Detection Test

Undergo Shield MCD test

Andra namn:
  • MCD -analys
  • MCD -test
  • MCED -analys
  • MCED -test
  • Analys av flera cancerdetektering
  • Multicancerupptäckningstest
  • Multicancer tidig detektionsanalys
  • Multicancer tidig detektionstest
  • Multi-cancerdetekteringsanalys
  • Multi-cancer tidig detektionsanalys
  • 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
Procedur: Multi-Cancer Early Detection Test

Undergo Avantect MCD test

Andra namn:
  • MCD -analys
  • MCD -test
  • MCED -analys
  • MCED -test
  • Analys av flera cancerdetektering
  • Multicancerupptäckningstest
  • Multicancer tidig detektionsanalys
  • Multicancer tidig detektionstest
  • Multi-cancerdetekteringsanalys
  • Multi-cancer tidig detektionsanalys
  • 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.
Procedur: Biospecimen Collection

Undergo blood collection

Andra namn:
  • Biologisk provsamling
  • Bioprov insamlat
  • Provsamling
  • Provuppsamling
Övrig: Electronic Health Record Review

Obtain health data

Övrig: Questionnaire Administration

Study specific questionnaires

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility of enrollment onto study
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Impact of participant blinding
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to 3 years

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

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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cancer stage
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to 12 years

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

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

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Scott D Ramsey, Fred Hutchinson Cancer Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

18 juni 2025

Primärt slutförande (Beräknad)

31 januari 2029

Avslutad studie (Beräknad)

30 juni 2029

Studieregistreringsdatum

Först inskickad

29 maj 2025

Först inskickad som uppfyllde QC-kriterierna

29 maj 2025

Första postat (Faktisk)

30 maj 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 november 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NCI-2024-10793
  • P30CA015704 (U.S.S. NIH-anslag/kontrakt)
  • NCI-2024-10793 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • CSRN1 (Annan identifierare: CTEP)
  • UG1CA286954 (U.S.S. NIH-anslag/kontrakt)
  • CSRN1 (Annan identifierare: Fred Hutchinson Cancer Center)
  • CSRN1 (Annan identifierare: DCP)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera