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Eine Studie zur Bewertung von Multicancer Detection (MCD) -Tests und deren Auswirkungen auf die Gesundheits- und Krebs -Screening der Teilnehmer, die Vanguard -Studie

5. November 2026 aktualisiert von: National Cancer Institute (NCI)

Die Vanguard -Studie: Testen einer neuen Möglichkeit, Krebs zu überprüfen

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).

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

24000

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

45 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Screening
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Arm I (Shield MCD test)

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

Undergo blood collection

Andere Namen:
  • Biologische Probensammlung
  • Bioprobe gesammelt
  • Probenentnahme
  • Beispielsammlung
Gerät: Device Usage

Evaluation of MCD tests

Andere Namen:
  • Nutzung des Geräts
Sonstiges: Electronic Health Record Review

Obtain health data

Sonstiges: Questionnaire Administration

Study specific questionnaires

Verfahren: Multi-Cancer Early Detection Test

Undergo Shield MCD test

Andere Namen:
  • MCD -Assay
  • MCD -Test
  • MCed Assay
  • MCED -Test
  • Multi -Cancer -Erkennungsassay
  • Multi -Cancer -Erkennungstest
  • Multi -Cancer -Früherkennungstest
  • Multi -Cancer Früherkennungstest
  • Erkennungsassay mit mehreren Krebs
  • Multi-Krebs-Früherkennungsassay
  • 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
Verfahren: Multi-Cancer Early Detection Test

Undergo Avantect MCD test

Andere Namen:
  • MCD -Assay
  • MCD -Test
  • MCed Assay
  • MCED -Test
  • Multi -Cancer -Erkennungsassay
  • Multi -Cancer -Erkennungstest
  • Multi -Cancer -Früherkennungstest
  • Multi -Cancer Früherkennungstest
  • Erkennungsassay mit mehreren Krebs
  • Multi-Krebs-Früherkennungsassay
  • Early detection (MSED) test
  • MSED Test
  • Multi-cancer detection (MCD) test
  • Multi-Cancer Detection Test
  • Multi-cancer early detection (MCED) test
  • Multi-cancer screening
  • Multi-cancer screening test
Experimental: Arm II (Avantect MCD test)

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

Undergo blood collection

Andere Namen:
  • Biologische Probensammlung
  • Bioprobe gesammelt
  • Probenentnahme
  • Beispielsammlung
Gerät: Device Usage

Evaluation of MCD tests

Andere Namen:
  • Nutzung des Geräts
Sonstiges: Electronic Health Record Review

Obtain health data

Sonstiges: Questionnaire Administration

Study specific questionnaires

Verfahren: Multi-Cancer Early Detection Test

Undergo Shield MCD test

Andere Namen:
  • MCD -Assay
  • MCD -Test
  • MCed Assay
  • MCED -Test
  • Multi -Cancer -Erkennungsassay
  • Multi -Cancer -Erkennungstest
  • Multi -Cancer -Früherkennungstest
  • Multi -Cancer Früherkennungstest
  • Erkennungsassay mit mehreren Krebs
  • Multi-Krebs-Früherkennungsassay
  • 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
Verfahren: Multi-Cancer Early Detection Test

Undergo Avantect MCD test

Andere Namen:
  • MCD -Assay
  • MCD -Test
  • MCed Assay
  • MCED -Test
  • Multi -Cancer -Erkennungsassay
  • Multi -Cancer -Erkennungstest
  • Multi -Cancer -Früherkennungstest
  • Multi -Cancer Früherkennungstest
  • Erkennungsassay mit mehreren Krebs
  • Multi-Krebs-Früherkennungsassay
  • 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
Aktiver Komparator: Arm III (Control)

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

Undergo blood collection

Andere Namen:
  • Biologische Probensammlung
  • Bioprobe gesammelt
  • Probenentnahme
  • Beispielsammlung
Sonstiges: Electronic Health Record Review

Obtain health data

Sonstiges: Questionnaire Administration

Study specific questionnaires

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility of enrollment onto study
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Impact of participant blinding
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 3 years

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

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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cancer stage
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 12 years

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

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

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Scott D Ramsey, Fred Hutchinson Cancer Center

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

18. Juni 2025

Primärer Abschluss (Geschätzt)

31. Januar 2029

Studienabschluss (Geschätzt)

30. Juni 2029

Studienanmeldedaten

Zuerst eingereicht

29. Mai 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Mai 2025

Zuerst gepostet (Tatsächlich)

30. Mai 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. November 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NCI-2024-10793
  • P30CA015704 (US NIH Stipendium/Vertrag)
  • NCI-2024-10793 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
  • CSRN1 (Andere Kennung: CTEP)
  • UG1CA286954 (US NIH Stipendium/Vertrag)
  • CSRN1 (Andere Kennung: Fred Hutchinson Cancer Center)
  • CSRN1 (Andere Kennung: DCP)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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