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临床试验/CTRI/2024/04/066395
CTRI/2024/04/066395尚未招募不适用

Understanding the role of fibroblast specific protein1 S100A4 in profibrotic and inflammatory pathways as a possible therapeutic target in managing endometriosis associated fibrosis

ICMR1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
ICMR
入组人数
26
试验地点
1
主要终点
Pearson correlation will be used to quantify the degree to which S100A4 abundance in peritoneal fluid and pain score/ quality of life scores are related. Similarly, the correlation between S100A4 level and disease status as per ASMR will also be calculated.

研究概览

简要总结

Conventional therapy-based interventions against endometriosis faces several implementation barriers. As a result, large proportion of woman suffering from endometriosis fail to access appropriate care. To improve the care, there is a critical need to identify novel interventions effective in treating endometriosis. The findings of the proposed study will help to advance our knowledge about RAGE  antagonist peptide based therapeutic intervention for managing fibrosis associated with endometriosis. If intervention is found to have a positive effect, it has the potential to make a major contribution for women with endometriosis. We are further correlating S100A4 level in peritoneal fluid and blood to the degree of severity of the endometriosis. If a statistical correlation is established, we can further develop this as a biomarker for the severity of the disease and recovery from the disease, which will be an invaluable tool to monitor women’s health in a non-invasive way

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • • The study will include women aged 18–40 years with who reported to the health centers due to complaints associated with endometriosis.
  • • Females with ultrasound, histologic, and surgical confirmation of endometriosis (by laparoscopy or laparotomy) accordance with the guidelines of the American Society for Reproductive Medicine within the last 2 years.

排除标准

  • • Patients suffering from any other chronic pain or cancer • patients with psychological disorders • patients who had undergone surgery on the abdomen other than for endometriosis • post-menopausal woman • Subjects with medical conditions in which a blood draw would be contraindicated (e.g., severe anemia) • use of antibiotics or probiotic/prebiotic supplements within 60 d of enrollment.

结局指标

主要结局

Pearson correlation will be used to quantify the degree to which S100A4 abundance in peritoneal fluid and pain score/ quality of life scores are related. Similarly, the correlation between S100A4 level and disease status as per ASMR will also be calculated.

时间窗: 12 months, 24 months, 36 months

次要结局

  • Concentration of IL1, IL2, IL8 in peritoneal fluid(2026, at the end of the project)

研究者

发起方
ICMR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Rahul Dutta

Kasturba Medical College

研究点 (1)

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