RecruitingNot applicable

Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares follow-up colon exams, called colonoscopies, at 10 years versus at both 5 and 10 years. It looks at how often colon or rectal cancer develops in people whose first exam found 1 or 2 small polyps without high-risk changes.

This trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign and date the study consent form.
  • Be age 45 to 69 at the time of the colonoscopy used to qualify.
  • Have a first diagnosis of 1 or 2 tubular adenomas—small growths called polyps—found within 4 years before study group assignment.
  • The polyps must be smaller than 10 millimeters and have no high-risk tissue or cell changes.
  • Certain flat polyps called sessile serrated polyps may also qualify if they have no advanced features.
  • The exam must reach the start of the colon, with the bowel clean enough to see clearly.
  • Have all seen polyps fully removed, though some hyperplastic polyps in the lower bowel do not need removal.
  • Be able to read or understand English or Spanish.

Who can't join

  • Have had colon or rectal cancer, or adenoma polyps before the qualifying exam; have ever had a hyperplastic polyp at least 1 centimeter wide; or have a traditional serrated adenoma at the qualifying exam.
  • Have had another cancer, unless cancer-free for at least 5 years and a doctor thinks it is unlikely to return. Exceptions include cancers that have not spread beyond where they started, and basal or squamous cell skin cancers treated within the past 5 years.
  • Have another colonoscopy after the qualifying exam but before study group assignment; have an incomplete qualifying exam; or have adenoma polyps that were not fully removed.
  • Have had most or all of the colon removed. Removal of only one section is allowed.
  • Have a parent, sibling, or child diagnosed with colon or rectal cancer at age 60 or younger, or two such relatives diagnosed at any age.
  • Have a diagnosis or positive gene test for an inherited condition that raises colon cancer risk, such as familial adenomatous polyposis or Lynch syndrome.
  • Have inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis.
  • Have other health problems that the study doctor expects will limit life to less than 10 years, or that prevent colonoscopies or required follow-up.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines. * Participants greater than or equal to 45 and less than 70 years of age at the time of colonoscopy. * Participants with a first-time diagnosis of 1-2 non-advanced tubular adenomas (less than 10 mm without tubulovillous or villous changes or high grade or severe dysplasia) from the qualifying colonoscopy within 4 years prior to randomization. * Sessile serrated polyps/adenomas, as long as they do not meet the criteria for advanced adenomas, will be considered as non-advanced adenomas. * Qualifying colonoscopy must be a complete colonoscopy with visualization of the cecum and with adequate cleansing within 4 years prior to randomization. * Complete excision of all observed polyps in qualifying colonoscopy * Participants must be able to read or understand English or Spanish. Exclusion Criteria: * • Prior history of colorectal cancer or colorectal adenomas including sessile serrated polyps/adenomas excluding those found on the qualifying colonoscopy. * Prior history of a hyperplastic polyp measuring greater than or equal to 1 cm in size. * Traditional serrated adenomas found on the qualifying colonoscopy. * Hyperplastic polyp measuring greater than or equal to 1 cm in size found on the qualifying colonoscopy. * Previous malignancies unless the patient has been disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: all in situ cancers and basal cell and squamous cell carcinoma of the skin. * Colonoscopy performed after the qualifying colonoscopy but prior to randomization. * Incomplete qualifying colonoscopy (e.g., cecum not visualized). * Incomplete endoscopic excision of adenomatous polyps based on colonoscopist impression at qualifying colonoscopy. (Excision of all hyperplastic rectosigmoid polyps is not required.) * Sub-total colectomy or total proctocolectomy. (Segmental resections are allowed.) * Family history of CRC diagnosed at less than or equal to 60 years of age in a first degree relative (mother, father, child, sibling) or in two first degree relatives with CRC at any age. * Participants with a clinical diagnosis of a significant heritable risk for colorectal cancer (Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \[Lynch Syndrome\]). * Participants tested positive for a Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \[Lynch Syndrome\] genetic mutation that increases risk of colorectal cancer. * Inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis). * Life expectancy less than 10 years due to comorbid conditions in the opinion of the investigator. * Other comorbid conditions that would prevent the participant from having colonoscopies or would prevent required follow-up.

Study sites (478)

AK

AR

AZ

CA

CO

CT

DC

FL

GA

HI

IA

ID

IL

IN

KS

KY

LA

MA

MD

ME

MI

MN

MO

MT

NC

ND

NE

NJ

NM

NV

NY

OH

OK

OR

PA

RI

  • Providence Veterans Administration Hospital · Providence, RI 02908Site Public Contact · Study contact · 866-590-2976Jeanette Giedrimas · Principal investigatorMore trials in Providence

SC

SD

TN

TX

UT

  • George E Wahlen Department of Veterans Affairs Medical Center · Salt Lake City, UT 84148Site Public Contact · Study contact · 801-582-1565Andrew J. Gawron · Principal investigatorMore trials in Salt Lake City

VA

WA

WI

WV

WY