Colorectal CancerNCT07678099
Screening Colonoscopy in Breast Cancer Patients
A study testing Screening colonoscopy in people with Colorectal Cancer and Breast Cancer, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Colorectal Cancer, Breast Cancer, Colorectal Adenoma
- What is being tested?
- Screening colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2024to 26 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpasa Numune Research and Training Hospital
Istanbul, Uskudar, 34668
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Colorectal Cancer, Breast Cancer, Colorectal Adenoma
- Being tested
- Screening colonoscopy
- Keywords
- breast cancer, screening colonoscopy, colorectal neoplasia
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening colonoscopyProcedure or surgery
Colonoscopic examination performed in asymptomatic breast cancer survivors after completion of breast cancer treatment to screen for colorectal neoplasia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Screening colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of screening colonoscopy
Secondary outcomes (2)
Adenoma Detection Rate (ADR)
The proportion of participants with at least one histologically confirmed adenomatous polyp identified during screening colonoscopy.
Measured: At the time of screening colonoscopy
Clinical and Pathological Factors Associated With Colorectal Neoplasia
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.
Measured: At the time of screening colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start12 Nov 2024
- Primary completion24 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naz Tayyar, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678099
- Sponsor's protocol ID
- HNEAH-GOAEK 2024/137 / KK/2024
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Colonoscopy In Patients With Breast Cancer: Prevalence Of Colorectal Neoplasia In A Prospective Cohort
- ClinicalTrials.gov ID
- NCT07678099
- Acronym / sponsor ID
- HNEAH-GOAEK 2024/137 / KK/2024
- Conditions
- Colorectal Cancer, Breast Cancer, Colorectal Adenoma
- Keywords
- breast cancer, screening colonoscopy, colorectal neoplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Survivors Undergoing Screening Colonoscopy | Experimental | Procedure: Screening colonoscopyFemale breast cancer survivors who completed primary breast cancer treatment and underwent screening colonoscopy for the detection of colorectal polyps, adenomas, and colorectal cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Age <18 years
- History of colorectal malignancy
- History of inflammatory bowel disease
- Inadequate bowel preparation (Boston Bowel Preparation Scale not adequate)
- Incomplete medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening colonoscopyColonoscopic examination performed in asymptomatic breast cancer survivors after completion of breast cancer treatment to screen for colorectal neoplasia. | Procedure or surgery | Breast Cancer Survivors Undergoing Screening Colonoscopy |
Primary outcome
Prevalence of Colorectal adenoma
Time frame: 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.
2 secondary outcomes
Adenoma Detection Rate (ADR)
Time frame: At the time of screening colonoscopy
Clinical and Pathological Factors Associated With Colorectal Neoplasia
Time frame: At the time of screening colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening colonoscopy in people with Colorectal Cancer and Breast Cancer, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Colorectal adenoma (time frame: At the time of screening colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.