Screening Colonoscopy in Breast Cancer Patients

NCT07678099 | Completed

• 1 other identifier: HNEAH-GOAEK 2024/137 / KK/2024
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer survivors may be at increased risk for developing colorectal polyps and colorectal cancer because of shared genetic, hormonal, and lifestyle-related risk factors. However, the prevalence of colorectal neoplasia in women with breast cancer has not been clearly established. This prospective screening study aims to evaluate the prevalence of colorectal polyps, adenomas, and colorectal cancer detected by screening colonoscopy in women who have completed treatment for breast cancer. The study also investigates whether clinical, pathological, and genetic characteristics of breast cancer are associated with the risk of colorectal neoplasia. All eligible participants undergo screening colonoscopy after completion of breast cancer treatment. The findings of this study may help identify breast cancer survivors who could benefit from individualized colorectal cancer screening strategies and contribute to improving long-term cancer survivorship care.

Conditions

Colorectal Cancer; Breast Cancer; Colorectal Adenoma

Keywords

breast cancer; screening colonoscopy; colorectal neoplasia

Outcome Measures

Primary Outcomes (1)

• Prevalence of Colorectal adenoma

  Proportion of participants with colorectal adenomas detected by screening colonoscopy. It is defined as the presence of adenomatous polyps confirmed by histopathological examination.

  At the time of screening colonoscopy

Secondary Outcomes (2)

• Adenoma Detection Rate (ADR)

  At the time of screening colonoscopy

• Clinical and Pathological Factors Associated With Colorectal Neoplasia

  At the time of screening colonoscopy

Study Arms (1)

Breast Cancer Survivors Undergoing Screening Colonoscopy

EXPERIMENTAL

Female breast cancer survivors who completed primary breast cancer treatment and underwent screening colonoscopy for the detection of colorectal polyps, adenomas, and colorectal cancer.

Procedure: Screening colonoscopy

Interventions

Screening colonoscopy PROCEDURE

Colonoscopic examination performed in asymptomatic breast cancer survivors after completion of breast cancer treatment to screen for colorectal neoplasia.

Breast Cancer Survivors Undergoing Screening Colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged ≥18 years
• Diagnosis of breast cancer
• Completed surgical and/or systemic treatment
• Underwent or planned to undergo screening colonoscopy after completion of breast cancer treatment
• Asymptomatic at the time of colonoscopy

You may not qualify if:

• Age \<18 years
• History of colorectal malignancy
• History of inflammatory bowel disease
• Inadequate bowel preparation (Boston Bowel Preparation Scale not adequate)
• Incomplete medical records
• Refusal to participate
• Colonoscopy performed for diagnostic purposes rather than screening
• Presence of gastrointestinal alarm symptoms (e.g., rectal bleeding, iron deficiency anemia, change in bowel habits, weight loss, abdominal pain, positive FIT/FOBT, or suspicious radiologic findings)

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

Study Sites (1)

Haydarpasa Numune Research and Training Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery Resident

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: July 1, 2026
• Study Start: November 12, 2024
• Primary Completion: November 24, 2025
• Study Completion: November 26, 2025
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 6 months after publication and ending 5 years after publication for researchers who provide a methodologically sound proposal, subject to institutional approval and applicable regulations regarding patient confidentiality.
• Access Criteria: Data will be available beginning 6 months after publication and ending 5 years after publication for researchers who provide a methodologically sound proposal, subject to institutional approval and applicable regulations regarding patient confidentiality.

Locations

TU (1)