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临床试验/NCT07678099
NCT07678099已完成不适用

Screening Colonoscopy In Patients With Breast Cancer: Prevalence Of Colorectal Neoplasia In A Prospective Cohort

Haydarpasa Numune Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2024年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
216
试验地点
1
主要终点
Prevalence of Colorectal adenoma

研究概览

简要总结

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.

详细描述

Breast cancer is the most commonly diagnosed malignancy among women worldwide. Improvements in early detection and treatment have substantially increased survival rates, leading to a growing population of breast cancer survivors. Consequently, the identification of secondary malignancies and long-term cancer-related health risks has become increasingly important.

Several epidemiological studies have suggested a possible association between breast cancer and colorectal neoplasia. Shared risk factors, including age, obesity, hormonal exposure, genetic susceptibility, and environmental influences, may contribute to the development of both malignancies. However, available evidence remains inconsistent, and prospective studies evaluating the prevalence of colorectal neoplasia in breast cancer survivors are limited.

This prospective single-center screening study was conducted to determine the prevalence of colorectal neoplasia detected by screening colonoscopy in women previously diagnosed with breast cancer. Female patients older than 18 years who had completed surgical, systemic, and/or adjuvant treatment for breast cancer were prospectively enrolled. All participants were asymptomatic with respect to gastrointestinal complaints and underwent screening colonoscopy after completion of breast cancer treatment. Patients undergoing colonoscopy for diagnostic indications or presenting with alarm gastrointestinal symptoms were excluded.

Clinical and demographic data, including age, body mass index, comorbidities, family history, breast cancer pathology, molecular subtype, Ki-67 proliferation index, treatment history, and available genetic testing results, were collected. Colonoscopic findings were recorded, and all detected lesions underwent histopathological evaluation. Adenomas were classified according to established histological criteria.

The primary objective of the study was to determine the prevalence of colorectal neoplasia, defined as adenomatous polyps and colorectal carcinoma, among breast cancer survivors undergoing screening colonoscopy. Secondary objectives included evaluation of adenoma detection rate (ADR), colorectal cancer prevalence, and identification of clinical, pathological, and genetic factors associated with colorectal neoplasia and colorectal cancer development.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Prevalence of Colorectal adenoma

时间窗: At the time of screening colonoscopy

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

次要结局

  • Adenoma Detection Rate (ADR)(At the time of screening colonoscopy)
  • Clinical and Pathological Factors Associated With Colorectal Neoplasia(At the time of screening colonoscopy)

研究者

发起方
Haydarpasa Numune Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Naz Tayyar

General Surgery Resident

Haydarpasa Numune Training and Research Hospital

研究点 (1)

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