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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01757 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000078532 | |||
| NCI-P93-0050 | |||
| PLCO-1 | |||
| PLCO-Colorectal | Other Identifier | National Cancer Institute |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colorectal Screening | Active Comparator | 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. |
|
| Control | No Intervention | Participants receive standard medical care. Participants complete a DHQ at baseline. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening Questionnaire Administration | Other | Undergo questionnaire assessments |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal Cancer Deaths | 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. |
| Colorectal Cancer Death Rates | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Deaths From All Causes | 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. |
| Death Rates From All Causes |
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Exclusion Criteria:
Men and women who at the time of randomization are less than 55 or greater than or equal to 75 years of age
Individuals undergoing treatment for cancer at this time, excluding basal-cell and squamous-cell skin cancer
Individuals with known prior cancer of the colon, rectum, lung, prostate
Individuals with previous surgical removal of the entire colon, one lung, or the entire prostate (men only)
Individuals who are participating in another cancer screening or cancer primary prevention trial
Males who have taken Proscar/Propecia/finasteride in the past 6 months
Individuals who are unwilling or unable to sign the informed consent form
Males who have had more than one PSA blood test in the past three years
Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past three years
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| Name | Affiliation | Role |
|---|---|---|
| Christine D Berg | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41261199 | Derived | 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. | |
| 38741776 |
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Participants signed a study informed consent prior to being randomized to a study arm.
Participants were enrolled between November 1993 and July 2001 at 10 study centers. Recruitment was done for all four outcomes of the study (prostate, lung, colorectal and ovarian).
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6. |
| FG001 | Colorectal Screening | Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (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 and all deaths that occur among both screened and control arm subjects during the trial. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6. |
| BG001 | Colorectal Screening |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Colorectal Cancer Deaths | Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. | Posted | Number | Participants | Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years. |
|
During each annual screening visit.
These events are solely those prompted by the screening examination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Colorectal Screening | Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (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 and all deaths that occur among both screened and control arm subjects during the trial. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul F. Pinsky, Ph.D. | Early Detection Research Group, NCI, NIH | 301-496-8544 | pinskyp@mail.nih.gov |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D012812 | Sigmoidoscopy |
| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
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| Sigmoidoscopy |
| Procedure |
Undergo a flexible sigmoidoscopy |
|
|
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. |
| Colorectal Cancer Incidence | 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. |
| Colorectal Cancer Incidence Rates | 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. |
| Complications of Diagnostic Evaluation Following a Positive Screening Test | Number of participants who experienced complications during diagnostic work-up of a positive colorectal examination. | One year from screening examination |
| T0 (Baseline) FSG Screening Results | Flexible sigmoidoscopy (FSG) result | T0 (at study entry) |
| T3/T5 FSG Screening Result | Flexible sigmoidoscopy (FSG) result | T3 (three years after entry) or T5 (five years after entry) |
| 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. |
| 34548240 | Derived | 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. |
| 33277073 | Derived | 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. |
| 26559156 | Derived | 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. |
| 26269366 | Derived | 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. |
| Died Before ASU (Control) |
|
| Refused ASU (Control) |
|
| Refused Screen (Colorectal Screening) |
|
Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (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 and all deaths that occur among both screened and control arm subjects during the trial.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Deaths From All Causes | Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm. | All participants. An intention-to-treat analysis was performed. | Posted | Number | Participants | Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years. |
|
|
|
| Secondary | Death Rates From All Causes | 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. | All participants. An intention-to-treat analysis was performed. | Posted | Number | Deaths per 10,000 PY | Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years. |
|
|
|
|
| Secondary | Colorectal Cancer Incidence | Colorectal cancer diagnoses confirmed by medical record abstraction. | All participants. An intention-to-treat analysis was performed. | Posted | Number | Participants | Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years. |
|
|
|
| Secondary | Colorectal Cancer Incidence Rates | 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. | All participants. An intention-to-treat analysis was performed. | Posted | Number | Diagnoses per 10,000 PY | Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years. |
|
|
|
|
| Secondary | Complications of Diagnostic Evaluation Following a Positive Screening Test | Number of participants who experienced complications during diagnostic work-up of a positive colorectal examination. | The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 2 positive screens with documented follow-up after each one, he would be counted 2 times in the number of units analyzed. | Posted | Number | Positive screens w/ complications | One year from screening examination | Positive Screens with Follow-up | Positive Screens with Follow-up |
|
|
|
| Primary | Colorectal Cancer Death Rates | 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. | Posted | Number | Deaths per 10,000 PY | Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years. |
|
|
|
|
| Secondary | T0 (Baseline) FSG Screening Results | Flexible sigmoidoscopy (FSG) result | All participants in the Colorectal Screening arm who had an FSG at T0 were analyzed. | Posted | Number | Participants | T0 (at study entry) |
|
|
|
| Secondary | T3/T5 FSG Screening Result | Flexible sigmoidoscopy (FSG) result | All participants in the Colorectal Screening arm who had an FSG at T0 or T3 were analyzed. | Posted | Number | Participants | T3 (three years after entry) or T5 (five years after entry) |
|
|
|
| 0 |
| 77,445 |
| 504 |
| 77,445 |
| Bleeding | General disorders | Non-systematic Assessment |
|
| Dizzy | General disorders | Non-systematic Assessment |
|
| Fainted | General disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Perforated Bowel | General disorders | Non-systematic Assessment |
|
| Other Adverse Event | General disorders | Non-systematic Assessment |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|