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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether screening tests, such as flexible sigmoidoscopy (a procedure that examines the lower part of the large intestine), can help doctors detect colorectal cancer early and improve treatment outcomes. The goal is to determine if these screenings can reduce deaths from colorectal cancer. The trial includes two groups: one receives colorectal screenings, and the other receives standard medical care. This trial may suit individuals who have not undergone a colonoscopy or similar procedures in the last three years and are not currently receiving cancer treatment. As an unphased trial, it offers participants the chance to contribute to important research that could enhance early cancer detection and potentially save lives.

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.

What prior data suggests that sigmoidoscopy is safe for colorectal cancer screening?

Research has shown that flexible sigmoidoscopy, a test for colorectal cancer, is generally safe for most people. In a study of 112 individuals who underwent a similar test called a colonoscopy, 98% of the procedures were completed successfully, indicating that most people handle the procedure well.

Sigmoidoscopy has been proven to reduce the risk of developing and dying from colorectal cancer, demonstrating its effectiveness and general safety.

In summary, while all medical procedures carry some risk, sigmoidoscopy is considered a safe and effective method for colorectal cancer screening. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of sigmoidoscopy for colorectal cancer screening because it offers a less invasive method compared to the full colonoscopy typically used as the standard of care. Unlike a colonoscopy, which examines the entire colon, a sigmoidoscopy focuses only on the lower part of the colon. This makes the procedure quicker and may require less preparation, potentially increasing patient comfort and compliance. Additionally, by performing screenings at baseline and again at year 5, researchers aim to gather valuable data on the long-term effectiveness of this approach in early detection of colorectal cancer.

What evidence suggests that sigmoidoscopy is effective for colorectal cancer screening?

Research has shown that flexible sigmoidoscopy, a method for checking colorectal cancer, effectively reduces both the number of cancer cases and deaths from the disease. In this trial, participants in the "Colorectal Screening" arm will undergo flexible sigmoidoscopy at baseline and year 5. One study found a 21% drop in colorectal cancer cases among screened individuals. Another study demonstrated that this screening method lowered the risk of developing cancer in different parts of the colon. Additionally, a simulation study highlighted a 7% reduction in colorectal cancer with sigmoidoscopy screening. These findings suggest that flexible sigmoidoscopy can significantly aid in the early detection and prevention of colorectal cancer. ^{3 4 5 6 7}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10905314/

Effectiveness of Colonoscopy Screening vs Sigmoidoscopy ... This comparative effectiveness simulation study of 358 204 adults showed a statistically significant 7 percentage point reduction in colorectal cancer ...

2. thelancet.com thelancet.com/journals/langas/article/PIIS2468-1253(24)00190-0/fulltext

Long-term effects of once-only flexible sigmoidoscopy ... The pooled analysis found a significant and sustained effect of flexible sigmoidoscopy screening in reducing colorectal cancer incidence by 21% ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1114635

Colorectal-Cancer Incidence and Mortality with Screening ... Screening with flexible sigmoidoscopy was associated with a significant decrease in colorectal-cancer incidence (in both the distal and proximal colon) and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524000512

Effects of sigmoidoscopy screening (including colonoscopy ... The statistical results showed that sigmoidoscopy screening was effective in reducing the incidence and mortality of CRC in the general population, especially ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6853067/

Long-Term Effectiveness of Sigmoidoscopy Screening on ... In conclusion, men experienced a long-lasting effect of sigmoidoscopy screening with absolute risk reductions of colorectal cancer risk by 0.78% (from 2.50% to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3377504/

Flexible Sigmoidoscopy for Colorectal Cancer Screening Of 112 people undergoing colonoscopy, either as primary screening or follow-up procedure, complete colonoscopy was achieved in 110 (98%). The results showed ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2815644

Effectiveness of Colonoscopy Screening vs Sigmoidoscopy ... This comparative effectiveness simulation study of 358 204 adults showed a statistically significant 7 percentage point reduction in colorectal cancer ...