ChiCTR1800015320Not yet recruitingUnknown
A pilot study on the association between gut microbiota and development of breast cancer in Hong Kong Chinese
香港中文大學1 site in 1 country600 target enrollmentStarted: April 10, 2018Last updated:
Interventions
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- profile of gut microbiota in hormonal receptor-positive breast cancer and controls
Study Overview
Brief Summary
Characterize and compare the structural and functional profile of gut microbiota between women with hormonal receptor-positive breast cancer and controls
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 100 (—)
- Sex
- Female
Inclusion Criteria
- •Chinese female;
- •Aged greater than or equal to 18 years (no upper age limit);
- •Either: with a newly (within 3 months without surgical intervention other than biopsy) suspected benign or malignant breast lesion(s) for which tissue sample has been/will be taken pathological diagnosis (regardless of the results);
- •OR: a bilateral mammogram / ultrasonic examination of the breast has been / will be performed within 3 months of enrollment (regardless of the results);
- •Willing to complete a questionnaire on medical history, life style and health information.
- •Willing to provide clinical findings and investigation results including pathology, radiography and ultrasonography reports related to the health status of breast.
- •Willing to donate a stool sample for this study (other optional samples include urine, blood and remaining breast tissue after completing pathological investigations).
- •Willing to provide a consent for study.
Exclusion Criteria
- •Had undergone surgical removal of part or whole breast tissue (other than biopsy);
- •Had received any treatment for malignant breast lesions including surgery, radiotherapy, chemotherapy or hormonal therapy;
- •History of any cancer (not include the current suspected/confirmed breast lesion);
- •Had received antibiotics with the last 3 weeks (can postpone stool collection to 3 weeks after completing antibiotic treatment);
- •History of inflammatory bowel diseases or diverticulitis;
- •History of gastric banding or bypass;
- •History of major gastric or intestinal surgery (not include endoscopy, biopsy, removal of polyps or haemorrhoids).
Arms & Interventions
Control group 3:
No
Intervention: No
Case group 1:
No
Case group 2:
No
Control group 1:
Control group 4:
No
Control group 2:
No
Outcomes
Primary Outcomes
profile of gut microbiota in hormonal receptor-positive breast cancer and controls
Time Frame: cross-sectional at enrollment
Secondary Outcomes
- Identify the correlations between gut and breast tissue microbiota among women with different subtypes of breast cancer or benign conditions.(cross-sectional at enrollment)
- Correlate gut microbiota with level of estrogens and estrogen metabolites in urine and blood, and with breast tissue microbiota.(cross-sectional at enrollment)
Investigators
Study Sites (1)
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