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Clinical Trials in Egypt / NCT05080673
Recruiting Not applicable

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

NCT05080673 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2022-02-09
Last updated
2026-09-02

Condition(s) studied

Adenocarcinoma of the ColonAdenocarcinoma of the Rectum

Investigational drug(s) / intervention(s)

5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy

5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy: 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.

Study summary

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

Sex
ALL
Min age
45 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (493)

FacilityCityRegionStatus
Fairbanks Memorial Hospital Fairbanks Alaska Active Not Recruiting
CTCA at Western Regional Medical Center Goodyear Arizona Recruiting
Kingman Regional Medical Center Kingman Arizona Recruiting
Cancer Center at Saint Joseph's Phoenix Arizona Recruiting
University of Arizona Cancer Center - Prevention Research Clinic Tucson Arizona Recruiting
Mercy Hospital Fort Smith Fort Smith Arkansas Recruiting
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas Suspended
CARTI Cancer Center Little Rock Arkansas Recruiting
Kaiser Permanente-Anaheim Anaheim California Recruiting
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California Recruiting
PCR Oncology Arroyo Grande California Recruiting
Kaiser Permanente-Baldwin Park Baldwin Park California Recruiting
Kaiser Permanente-Bellflower Bellflower California Recruiting
Mercy Cancer Center - Carmichael Carmichael California Recruiting
Mercy San Juan Medical Center Carmichael California Recruiting
Epic Care-Dublin Dublin California Active Not Recruiting
Mercy Cancer Center - Elk Grove Elk Grove California Recruiting
Bay Area Breast Surgeons Inc Emeryville California Active Not Recruiting
Epic Care Partners in Cancer Care Emeryville California Active Not Recruiting
Kaiser Permanente-Fontana Fontana California Recruiting
Kaiser Permanente South Bay Harbor City California Recruiting
Kaiser Permanente-Irvine Irvine California Recruiting
Kaiser Permanente Los Angeles Medical Center Los Angeles California Recruiting
Kaiser Permanente West Los Angeles Los Angeles California Recruiting
UCLA / Jonsson Comprehensive Cancer Center Los Angeles California Recruiting
Contra Costa Regional Medical Center Martinez California Recruiting
Mercy Cancer Center Merced California Recruiting
Alta Bates Summit Medical Center - Summit Campus Oakland California Suspended
Bay Area Tumor Institute Oakland California Active Not Recruiting
Kaiser Permanente-Ontario Ontario California Recruiting
Stanford Cancer Institute Palo Alto Palo Alto California Recruiting
Kaiser Permanente - Panorama City Panorama City California Recruiting
Kaiser Permanente-Riverside Riverside California Recruiting
Mercy Cancer Center - Rocklin Rocklin California Recruiting
Mercy Cancer Center - Sacramento Sacramento California Recruiting
Kaiser Permanente-Rio San Diego San Diego California Recruiting
Kaiser Permanente-San Diego Zion San Diego California Recruiting
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California Recruiting
Kaiser Permanente-San Marcos San Marcos California Recruiting
Mission Hope Medical Oncology - Santa Maria Santa Maria California Recruiting

+ 453 more sites — see the full list on the official registry below.

More NRG Oncology trials in Egypt

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05080673 on ClinicalTrials.gov ↗ ← All trials in Egypt