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

ConditionsAdenocarcinoma of the ColonAdenocarcinoma of the Rectum
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-70
SponsorNRG Oncology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

• 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy

    Procedure/Surgery

    The five- and ten-year colonoscopies, in addition to any unscheduled colonoscopies, will be performed according to currently accepted guidelines for the performance of quality colonoscopy. Participants will be given the standardized colonoscopy preparation instructions per institutional standards.

Treatment groups

9,500 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of colorectal cancer

To examine 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.

Time frame
10 years

Secondary outcomes

Other outcomes

1

Incidence of advanced adenoma

To examine advanced adenoma 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.

Time frame
10 years
2

Colorectal cancer mortality

To examine colorectal cancer mortality 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.

Time frame
10 years
3

Incidence of stage III-IV colorectal cancer

To examine stage III-IV 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.

Time frame
10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NRG Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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