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临床试验/NCT07048327
NCT07048327招募中不适用

Cohort Study of Intrauterine Diseases

Wenwen Wang1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
The recurrence of endometrial polyps or endometrial hyperplasia.

研究概览

简要总结

"This study employs a prospective cohort design by establishing a uterine cavity diseases research platform. The investigators will collect participants' current medical history, menstrual and obstetric history, past medical history, physical and gynecological examinations, imaging studies, laboratory tests, and pathological examinations. After the hysteroscopic surgery, the investigators will conduct a one-year follow-up on the disease progression of the participants. Through this comprehensive approach, the investigators aim to deeply investigate the pathogenesis, risk factors, and optimized treatment strategies for uterine cavity diseases."

详细描述

Uterine cavity diseases are a common category of hormone-dependent gynecological conditions, encompassing a wide spectrum from benign lesions to malignant tumors, including endometrial hyperplasia, endometrial polyps, and endometrial malignancies.

Endometrial hyperplasia is classified into two types: hyperplasia without atypia and atypical hyperplasia. Atypical hyperplasia is considered a precancerous lesion of endometrial malignancies, which may lead to irregular vaginal bleeding, menstrual disorders, and carries the risk of malignant transformation. Endometrial polyps, a common benign lesion within the uterine cavity, often cause abnormal uterine bleeding, infertility, or recurrent miscarriages, significantly impacting women's reproductive health and quality of life. Endometrial malignancies, the most prevalent malignant tumors in the female reproductive system, pose a serious threat to women's lives and safety. These diseases not only profoundly affect women's physical health but also have far-reaching negative consequences on their mental well-being, social functioning, and overall quality of life.

In light of this, this study aims to utilize patients' clinical data resources to establish a cohort research platform for uterine cavity diseases, bridging the gap between clinical practice and scientific research, and providing valuable clinical data resources for in-depth studies on these conditions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: 18-80 years;
  • Patients requiring hysteroscopy or diagnostic curettage for intrauterine pathologies (e.g., endometrial hyperplasia, endometrial polyps, submucosal uterine fibroids, adenomyosis, or endometrial malignancies);
  • Willing and able to comply with follow-up requirements;
  • Signed informed consent obtained.

排除标准

  • Concurrent participation in other drug clinical trials;
  • Contraindications to or inability to tolerate hysteroscopy/curettage procedures;
  • Unwilling or unable to provide informed consent;
  • Unwilling or unable to adhere to study protocols.

结局指标

主要结局

The recurrence of endometrial polyps or endometrial hyperplasia.

时间窗: Follow up every three months for one year after hysteroscopic surgery

To evaluate the presence of disease progression and recurrence through imaging results.

次要结局

未报告次要终点

研究者

发起方
Wenwen Wang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wenwen Wang

Clinical Professor

Tongji Hospital

研究点 (1)

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