고령 환자의 대장암 검진(PLCO Screening Trial)
전립선, 폐, 결장직장 및 난소(PLCO) 암 검진 시험
This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for colorectal cancer.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
PRIMARY OBJECTIVES:
I. To determine whether screening with flexible sigmoidoscopy (60-cm sigmoidoscope) can reduce mortality from colorectal cancer in women and men aged 55-74 at study entry.
SECONDARY OBJECTIVES:
I. To assess screening variables, other than mortality, for each of the interventions including sensitivity, specificity, and positive predictive value.
II. To assess the incidence, stage, and survival of cancer cases. III. To investigate the mortality predictive value of biologic and/or prognostic characterizations of tumor tissue as intermediate endpoints.
IV. To conduct biomolecular and genetic research into factors associated with cancer carcinogenesis and promotion, as well as the early detection of these factors.
OUTLINE: Participants in the overall PLCO study are stratified by screening center, gender, and age (55-59 vs 60-64 vs 65-69 vs 70-74). Participants are randomized to 1 of 2 arms (control vs screening).
ARM I (Control): Participants receive standard medical care. Participants complete a Diet History Questionnaire (DHQ) at baseline.
ARM II (Colorectal Screening): Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. A scheduling and tracking procedure is implemented to ensure regular attendance at repeat screens for participants screened negative or for those who are designated suspicious or positive at screening but for whom subsequent diagnostic procedures do not reveal colorectal cancer (follow-up diagnostic procedures are through their own medical care environment). Participants diagnosed with colorectal cancer via a screening test are referred for treatment in accordance with current accepted practice for appropriate stage of disease, patient age, and medical condition; a procedure is provided for contact with qualified medical personnel to insure appropriate therapy.
Participants complete a Dietary Questionnaire (DQX) at baseline and DHQ at year 3. An Annual Study Update (ADU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers as all deaths that occur among both screened and control subjects during the trial.
After completion of screening, participants are followed up for at least 13 years.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Maryland
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Bethesda, Maryland, 미국, 20892
- National Institutes of Health Clinical Center
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Exclusion Criteria:
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Men and women who at the time of randomization are less than 55 or greater than or equal to 75 years of age
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Individuals undergoing treatment for cancer at this time, excluding basal-cell and squamous-cell skin cancer
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Individuals with known prior cancer of the colon, rectum, lung, prostate
- This includes primary or metastatic PLCO cancers
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Individuals with previous surgical removal of the entire colon, one lung, or the entire prostate (men only)
- Until October 1996, women with previous surgical removal of both ovaries were excluded from the trial. In order to increase the enrollment of women into the trial, beginning in October 1996, these women were no longer excluded for this reason.
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Individuals who are participating in another cancer screening or cancer primary prevention trial
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Males who have taken Proscar/Propecia/finasteride in the past 6 months
- NOTE: Individuals who are already enrolled in the trial when their physician prescribes finasteride are not prevented from taking this medication. As a result, these participants will continue to be screened and followed just as those participants who are not on finasteride.
- NOTE: Men who are taking Tamoxifen are not excluded from any part of the PLCO Screening Trial.
- Prior to April 1, 1999 women were excluded from the trial if they were currently taking or had taken Tamoxifen or Evista\Raloxifene in the past 6 months. As of April 1999 based on a decision from the PLCO Ovary Subcommittee, women who have or are currently taking Tamoxifen or Evista\Raloxifene are not excluded from participation.
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Individuals who are unwilling or unable to sign the informed consent form
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Males who have had more than one PSA blood test in the past three years
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Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past three years
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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간섭 없음: Control
Participants receive standard medical care. Participants complete a DHQ at baseline. |
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활성 비교기: Colorectal Screening
Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a DQX at baseline and DHQ at year 3. An ADU (previously referred to as the PSH questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers as all deaths that occur among both screened and control subjects during the trial. |
Undergo questionnaire assessments Undergo a flexible sigmoidoscopy
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Colorectal Cancer Deaths
기간: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
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Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. |
Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
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Colorectal Cancer Death Rates
기간: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
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Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study. |
Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Deaths From All Causes
기간: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
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Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm. |
Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
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Death Rates From All Causes
기간: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
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Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study. |
Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
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Colorectal Cancer Incidence
기간: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
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Colorectal cancer diagnoses confirmed by medical record abstraction. |
Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
|
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Colorectal Cancer Incidence Rates
기간: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
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Colorectal cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as colorectal cancer diagnoses divided by person years at risk for colorectal cancer. |
Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.
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Complications of Diagnostic Evaluation Following a Positive Screening Test
기간: One year from screening examination
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Number of participants who experienced complications during diagnostic work-up of a positive colorectal examination. |
One year from screening examination
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T0 (Baseline) FSG Screening Results
기간: T0 (at study entry)
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Flexible sigmoidoscopy (FSG) result |
T0 (at study entry)
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T3/T5 FSG Screening Result
기간: T3 (three years after entry) or T5 (five years after entry)
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Flexible sigmoidoscopy (FSG) result |
T3 (three years after entry) or T5 (five years after entry)
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Christine D Berg, National Cancer Institute (NCI)
간행물 및 유용한 링크
일반 간행물
- Jiang Y, Xie Q, Chen R. Breast Cancer Incidence and Mortality in Relation to Hormone Replacement Therapy Use Among Postmenopausal Women: Results From a Prospective Cohort Study. Clin Breast Cancer. 2022 Feb;22(2):e206-e213. doi: 10.1016/j.clbc.2021.06.010. Epub 2021 Jun 26.
- Wang K, Wu Q, Li Z, Reger MK, Xiong Y, Zhong G, Li Q, Zhang X, Li H, Foukakis T, Xiang T, Zhang J, Ren G. Vitamin K intake and breast cancer incidence and death: results from a prospective cohort study. Clin Nutr. 2021 May;40(5):3370-3378. doi: 10.1016/j.clnu.2020.11.009. Epub 2020 Nov 16.
- Kunzmann AT, Coleman HG, Huang WY, Cantwell MM, Kitahara CM, Berndt SI. Fruit and vegetable intakes and risk of colorectal cancer and incident and recurrent adenomas in the PLCO cancer screening trial. Int J Cancer. 2016 Apr 15;138(8):1851-61. doi: 10.1002/ijc.29922. Epub 2015 Dec 8.
- Kunzmann AT, Coleman HG, Huang WY, Kitahara CM, Cantwell MM, Berndt SI. Dietary fiber intake and risk of colorectal cancer and incident and recurrent adenoma in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. Am J Clin Nutr. 2015 Oct;102(4):881-90. doi: 10.3945/ajcn.115.113282. Epub 2015 Aug 12.
- Malcomson FC, Shams-White MM, Reedy J, Huang WY, Moore SC, Loftfield E. Adherence to the 2018 World Cancer Research Fund/American Institute for Cancer Research Cancer Prevention Recommendations and risk of lifestyle-related cancers in the prostate, lung, colorectal, and ovarian cancer screening trial. BJC Rep. 2025 Nov 19;3(1):81. doi: 10.1038/s44276-025-00195-6.
- Fan Z, Zhang Y, Yao Q, Liu X, Duan H, Liu Y, Sheng C, Lyu Z, Yang L, Song F, Huang Y, Song F. Effects of joint screening for prostate, lung, colorectal, and ovarian cancer - results from a controlled trial. Front Oncol. 2024 Apr 29;14:1322044. doi: 10.3389/fonc.2024.1322044. eCollection 2024.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- NCI-2012-01757
- CDR0000078532
- NCI-P93-0050
- PLCO-1
- NCI-2012-01757 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- PLCO-Colorectal (기타 식별자: National Cancer Institute)
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