Cohort Study of Intrauterine Diseases

Обзор

"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."

Подробное описание

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.

Вмешательства

• Другое No intervention (observational study)
  No intervention (observational study)

Первичные конечные точки

• The recurrence of endometrial polyps or endometrial hyperplasia. [Срок оценки: Follow up every three months for one year after hysteroscopic surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT07048327 · CSID

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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