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Screening Colonoscopy in Breast Cancer Patients

28. Juni 2026 aktualisiert von: Naz Tayyar, Haydarpasa Numune Training and Research Hospital

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

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.

Studienübersicht

Status

Abgeschlossen

Intervention / Behandlung

Detaillierte Beschreibung

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.

The results of this study may contribute to the development of risk-adapted colorectal cancer screening strategies in breast cancer survivors and improve understanding of factors associated with colorectal neoplasia in this population.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

216

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Uskudar
      • Istanbul, Uskudar, Türkei (türkiye), 34668
        • Haydarpasa Numune Research and Training Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Screening
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Breast Cancer Survivors Undergoing Screening Colonoscopy
Female breast cancer survivors who completed primary breast cancer treatment and underwent screening colonoscopy for the detection of colorectal polyps, adenomas, and colorectal cancer.
Colonoscopic examination performed in asymptomatic breast cancer survivors after completion of breast cancer treatment to screen for colorectal neoplasia.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Prevalence of Colorectal adenoma
Zeitfenster: 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.
At the time of screening colonoscopy

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adenoma Detection Rate (ADR)
Zeitfenster: At the time of screening colonoscopy
The proportion of participants with at least one histologically confirmed adenomatous polyp identified during screening colonoscopy.
At the time of screening colonoscopy
Clinical and Pathological Factors Associated With Colorectal Neoplasia
Zeitfenster: At the time of screening colonoscopy
Evaluation of demographic, clinical, pathological, and genetic variables associated with the presence of colorectal neoplasia, including age, height (m), weight (kg), weight and height will be combined to report BMI in kg/m^2, comorbidities, family history, breast cancer molecular subtype, Ki-67 proliferation index, and genetic alterations.
At the time of screening colonoscopy

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

12. November 2024

Primärer Abschluss (Tatsächlich)

24. November 2025

Studienabschluss (Tatsächlich)

26. November 2025

Studienanmeldedaten

Zuerst eingereicht

5. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Juni 2026

Zuerst gepostet (Tatsächlich)

1. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Individual participant data underlying the results reported in this study, after de-identification, will be available upon reasonable request to the corresponding author. The study protocol will also be made available.

IPD-Sharing-Zeitrahmen

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.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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