이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

MCD (Multicancer Detection) 테스트를 평가하는 연구 및 참가자 건강 및 암 스크리닝에 미치는 영향, Vanguard Study

2026년 11월 5일 업데이트: National Cancer Institute (NCI)

Vanguard Study : 암을 선별하는 새로운 방법 테스트

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).

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

24000

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

45년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 상영
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
절차: Biospecimen Collection

Undergo blood collection

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
장치: Device Usage

Evaluation of MCD tests

다른 이름들:
  • 장치 사용
다른: Electronic Health Record Review

Obtain health data

다른: Questionnaire Administration

Study specific questionnaires

절차: Multi-Cancer Early Detection Test

Undergo Shield MCD test

다른 이름들:
  • MCD 분석
  • MCD 테스트
  • Mced 분석
  • MCED 테스트
  • 다중 암 검출 분석
  • 다중 암 탐지 검사
  • 다중 암 조기 검출 분석
  • 다중 암 조기 탐지 테스트
  • 다중 암 초기 탐지 분석
  • 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
절차: Multi-Cancer Early Detection Test

Undergo Avantect MCD test

다른 이름들:
  • MCD 분석
  • MCD 테스트
  • Mced 분석
  • MCED 테스트
  • 다중 암 검출 분석
  • 다중 암 탐지 검사
  • 다중 암 조기 검출 분석
  • 다중 암 조기 탐지 테스트
  • 다중 암 초기 탐지 분석
  • 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
실험적: 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.
절차: Biospecimen Collection

Undergo blood collection

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
장치: Device Usage

Evaluation of MCD tests

다른 이름들:
  • 장치 사용
다른: Electronic Health Record Review

Obtain health data

다른: Questionnaire Administration

Study specific questionnaires

절차: Multi-Cancer Early Detection Test

Undergo Shield MCD test

다른 이름들:
  • MCD 분석
  • MCD 테스트
  • Mced 분석
  • MCED 테스트
  • 다중 암 검출 분석
  • 다중 암 탐지 검사
  • 다중 암 조기 검출 분석
  • 다중 암 조기 탐지 테스트
  • 다중 암 초기 탐지 분석
  • 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
절차: Multi-Cancer Early Detection Test

Undergo Avantect MCD test

다른 이름들:
  • MCD 분석
  • MCD 테스트
  • Mced 분석
  • MCED 테스트
  • 다중 암 검출 분석
  • 다중 암 탐지 검사
  • 다중 암 조기 검출 분석
  • 다중 암 조기 탐지 테스트
  • 다중 암 초기 탐지 분석
  • 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
활성 비교기: Arm III (Control)

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

Undergo blood collection

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
다른: Electronic Health Record Review

Obtain health data

다른: Questionnaire Administration

Study specific questionnaires

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Feasibility of enrollment onto study
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Impact of participant blinding
기간: 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
기간: 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
기간: 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
기간: Up to 3 years

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

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

기타 결과 측정

결과 측정
측정값 설명
기간
Cancer stage
기간: 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
기간: 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
기간: 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
기간: Up to 12 years

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

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

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Cancer Institute (NCI)

수사관

  • 수석 연구원: Scott D Ramsey, Fred Hutchinson Cancer Center

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 6월 18일

기본 완료 (추정된)

2029년 1월 31일

연구 완료 (추정된)

2029년 6월 30일

연구 등록 날짜

최초 제출

2025년 5월 29일

QC 기준을 충족하는 최초 제출

2025년 5월 29일

처음 게시됨 (실제)

2025년 5월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 5일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NCI-2024-10793
  • P30CA015704 (미국 NIH 보조금/계약)
  • NCI-2024-10793 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
  • CSRN1 (기타 식별자: CTEP)
  • UG1CA286954 (미국 NIH 보조금/계약)
  • CSRN1 (기타 식별자: Fred Hutchinson Cancer Center)
  • CSRN1 (기타 식별자: DCP)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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