ChiCTR1800015320尚未招募Unknown
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 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2018年4月10日最近更新:
干预措施
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- profile of gut microbiota in hormonal receptor-positive breast cancer and controls
研究概览
简要总结
Characterize and compare the structural and functional profile of gut microbiota between women with hormonal receptor-positive breast cancer and controls
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 100（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Control group 3:
No
干预措施: No
Case group 1:
No
Case group 2:
No
Control group 1:
Control group 4:
No
Control group 2:
No
结局指标
主要结局
profile of gut microbiota in hormonal receptor-positive breast cancer and controls
时间窗: cross-sectional at enrollment
次要结局
- 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)
研究者
研究点 (1)
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