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Cancer Screening for Colorectal Cancer

N/A

Waitlist Available

Led By Christine D Berg

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Individuals with known prior cancer of the colon, rectum, lung, prostate, including primary or metastatic PLCO cancers

Men and women who are less than 55 or greater than or equal to 75 years of age at the time of randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up events through 13 years of follow-up or through december 31, 2009; median follow-up 12.1 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether cancer screening methods can reduce deaths from prostate, lung, colon, rectum, or ovarian cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Sigmoidoscopy may cause discomfort, bleeding, or rarely perforation of the colon. The screening questionnaire has no physical side effects but may involve time commitment and privacy considerations.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer in my colon, rectum, lung, prostate, or PLCO-related cancers.

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I am under 55 or over 75 years old.

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I have had surgery to remove my entire colon, one lung, or my entire prostate.

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I am currently being treated for cancer, not including basal or squamous skin cancer.

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I am a male who has had multiple PSA tests in the last 3 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ events through 13 years of follow-up or through december 31, 2009; median follow-up 12.1 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~events through 13 years of follow-up or through december 31, 2009; median follow-up 12.1 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and events through 13 years of follow-up or through december 31, 2009; median follow-up 12.1 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Colorectal Cancer Death Rates

Colorectal Cancer Deaths

Secondary study objectives

Colorectal Cancer Incidence

Colorectal Cancer Incidence Rates

Complications of Diagnostic Evaluation Following a Positive Screening Test

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Colorectal ScreeningActive Control2 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: ControlActive Control1 Intervention

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

0 / 5Eligibility criteria met