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临床试验/NCT05316740
NCT05316740进行中(未招募)不适用

Vaginal Microbiome and the Risk of Vulvovaginal Graft Versus Host Disease Following Hematopoietic Stem Cell Transplantation

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Microbiome composition

研究概览

简要总结

Allogeneic stem cell transplantation (also termed "bone marrow transplantation") involves transferring stem cells from a healthy person (the donor) to the patient, after high-intensity chemotherapy or radiation, given to destroy any remaining cancer cells in the body. When a transplant is successful, the donor stem cells replace the original cells in the bone marrow. It may provide the only long-term cure of the patient's disease. Of transplant-related complications, graft-versus-host disease (GVHD) is one of the most important complications. GVHD arises from donor immune cells, that identify the recipient's (the patien's) cells as foreign and attack them. Approximately half of women undergoing transplantation will experience GVHD involving the genitalia (i.e., the vulva and vagina), termed vulvovaginal GVHD (VV-GVHD). VV-GVHD may cause irreversible anatomical changes, including complete vaginal obliteration, and not surprisingly, it has a severe impact on patients' quality of life and sexual function. This complication is unpredictable and non-preventable by the usual immunosuppressive treatment given to patients. Frequent gynecological examinations and prolonged follow-up of transplanted women are needed, to allow early diagnosis and prevention of harmful results of VV-GVHD. This follow-up adds inconvenience and anxiety to the patients.

The suggested study aims to evaluate a possible association between vaginal microorganisms (the "microbiome") to the progress of VV-GVHD. Finding such association may allow prediction of VV-GVHD progress, a better understanding of the development of VV-GVHD and a potential to develop interventions for the treatment and prevention of VV-GVHD.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Candidate for allogeneic stem cell transplantation
  • Ability to sign an informed consent

排除标准

  • Patient does not approve sample collection

结局指标

主要结局

Microbiome composition

时间窗: 2 years

Characterization of the vaginal microbial community using shotgun analysis and16S rRNA sequencing

CMV presence

时间窗: 2 years

Evaluation of CMV in vaginal samples using PCR assay

Vulvovaginal graft vs host disease presence

时间窗: 2 years

Evaluation of presence of vulvovaginal GVHD by gynecologic examination, using the NIH classification system for chronic graft-versus-host disease

次要结局

  • HPV presence(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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