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Screening Colonoscopy in Breast Cancer Patients

28. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

216

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Uskudar
      • Istanbul, Uskudar, Tyrkia (Türkiye), 34668
        • Haydarpasa Numune Research and Training Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prevalence of Colorectal adenoma
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adenoma Detection Rate (ADR)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. november 2024

Primær fullføring (Faktiske)

24. november 2025

Studiet fullført (Faktiske)

26. november 2025

Datoer for studieregistrering

Først innsendt

5. juni 2026

Først innsendt som oppfylte QC-kriteriene

28. juni 2026

Først lagt ut (Faktiske)

1. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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