Cancer Screening for Colorectal Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Cancer Institute (NCI)

Must not be taking: Proscar, Propecia, Finasteride

Disqualifiers: Cancer treatment, Prior cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

154900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial does not require you to stop taking your current medications. However, if you are a male who has taken Proscar/Propecia/finasteride in the past 6 months, you cannot join the trial. If you are already in the trial and your doctor prescribes finasteride, you can continue taking it.

Is flexible sigmoidoscopy safe for colorectal cancer screening?

Flexible sigmoidoscopy is generally safe for colorectal cancer screening, but there is a small risk of gastrointestinal complications and heart issues like heart attacks. ^{1 2 3 4 5}

How does sigmoidoscopy differ from other treatments for colorectal cancer?

Sigmoidoscopy is a screening procedure that helps detect colorectal cancer early by examining the lower part of the colon, which can reduce cancer incidence and mortality. Unlike other treatments that may involve medication or surgery, sigmoidoscopy is a diagnostic tool that allows for early detection and prevention, potentially reducing the need for more invasive treatments. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Sigmoidoscopy for colorectal cancer screening?

Research shows that screening with sigmoidoscopy can significantly reduce the incidence and mortality of colorectal cancer, particularly in the lower part of the colon. One study found that it reduced the risk of developing cancer in this area by about 76% and these benefits lasted for up to 16 years. ^{6 11 12 13 14}

Who Is on the Research Team?

Christine D Berg

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

This trial is for men and women aged 55 to 74 who haven't had certain cancer screenings in the past three years. It's not for those with a history of specific cancers, major organ removals, or current cancer treatment (except some skin cancers). Women who've had both ovaries removed could join after October 1996.

Exclusion Criteria

I am a male who has not taken Proscar, Propecia, or finasteride in the last 6 months.

You cannot participate if you are already involved in another trial for cancer screening or prevention.

Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past three years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Colorectal Screening

Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5

5 years

2 visits (in-person)

Follow-up

Participants are monitored for colorectal cancer incidence and mortality for at least 13 years

13 years

Annual follow-up (mail survey)

What Are the Treatments Tested in This Trial?

Interventions

• Sigmoidoscopy

Trial Overview The study tests if sigmoidoscopy (a procedure to look inside the lower part of the large intestine) and a screening questionnaire can help detect colorectal cancer early and reduce death rates from this disease.

How Is the Trial Designed?

Group I: Colorectal Screening Active Control 2 Interventions

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.

Group II: Control Active Control 1 Intervention

Participants receive standard medical care. Participants complete a DHQ at baseline.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 17,067 CT colonography examinations across 50 centers, only 0.08% of patients experienced potentially serious adverse events, indicating a very low incidence of complications associated with the procedure.

Among the adverse events, there were nine perforations, with a symptomatic perforation rate of just 0.03%, suggesting that while complications can occur, they are rare and often asymptomatic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potentially serious adverse events at CT colonography in symptomatic patients: national survey of the United Kingdom. Burling, D., Halligan, S., Slater, A., et al.[2016]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

A case-control study of screening sigmoidoscopy and mortality from colorectal cancer. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Screening endoscopy and risk of colorectal cancer in United States men. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Screening sigmoidoscopy and colorectal cancer mortality. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term efficacy of sigmoidoscopy in the reduction of colorectal cancer incidence. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effect of screening sigmoidoscopy and screening colonoscopy on colorectal cancer incidence and mortality: systematic review and meta-analysis of randomised controlled trials and observational studies. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Complications of screening flexible sigmoidoscopy. [2004]

7. United States pubmed.ncbi.nlm.nih.gov

Mortality and Rate of Hospitalization in a Colonoscopy Screening Program From a Randomized Health Services Study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Potentially serious adverse events at CT colonography in symptomatic patients: national survey of the United Kingdom. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

In adults, sigmoidoscopy screening invitation reduced CRC incidence and related mortality at 15 y. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Screening for colorectal cancer with flexible sigmoidoscopy by nonphysician endoscopists. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Screening for colorectal cancer. [2004]

12. United States pubmed.ncbi.nlm.nih.gov

Achieving quality in flexible sigmoidoscopy screening for colorectal cancer. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. [2022]

14. Australia pubmed.ncbi.nlm.nih.gov

Difficult or incomplete flexible sigmoidoscopy: implications for a screening programme. [2019]