Clinical trial · Interventional
Screening for Colorectal Cancer in Older Patients (PLCO Screening Trial)
Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial
NCT01696981CI-TRIAL-00119304active not recruitingN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Carcinoma | Colon Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Rectal Carcinoma | Rectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Screening Questionnaire Administration | Other | — | UNRESOLVED |
| Sigmoidoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Colorectal Screening
- description
- 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.
- interventionNames
- Other: Screening Questionnaire Administration
- Procedure: Sigmoidoscopy
- type
- NO_INTERVENTION
- label
- Control
- description
- Participants receive standard medical care. Participants complete a DHQ at baseline.
Primary outcomes (2)
- measure
- Colorectal Cancer Deaths
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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 * This includes primary or metastatic PLCO cancers * 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. * 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 * 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. * 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
References
Publications (6)
- DERIVEDMalcomson 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. PMID 41261199
- DERIVEDFan 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. PMID 38741776
- DERIVEDJiang 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. PMID 34548240
- DERIVEDWang 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. PMID 33277073
- DERIVEDKunzmann 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. PMID 26559156
- DERIVEDKunzmann 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.