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临床试验/NCT06294886
NCT06294886招募中不适用

Vaginal Fluid Collection Study for Endometrial Cancer Test Research and Development

Innovis LLC1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Detection of endometrial cancer and precancer

研究概览

简要总结

The primary objective of this study is to obtain de-identified vaginal fluid specimens from participants with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia or endometrial intraepithelial neoplasia (EIN).

The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of EC, AEH and EIN.

详细描述

For participants providing written informed consent to participate in the study, samples of vaginal fluid will be obtained by the Principal Investigator (PI) during a pelvic examination. All vaginal fluid samples will be collected ≥7 days after the endometrial biopsy and prior to initiating any therapeutic interventions including surgery, chemotherapy, radiation or hormonal therapy PIs will be provided with multiple, individually packaged Copan eNat® sterile sample collection kits including a swab and a transport tube containing a stabilizer and preservative medium as well as a pre-addressed shipping container and single-use tubes of sterile saline solution After vaginal fluid sample collection, the swab will be inserted into the tube for storage and subsequent shipping to the Sponsor's designated laboratory. The samples can be stored at ambient temperature and should be shipped to the designated laboratory within 24 hours of collection. Site(s) will provide the Sponsor with de-identified endometrial biopsy histopathology report and post-surgery histopathology report (if any) confirming the histopathological diagnosis of EC, AEH or EIN. The final diagnosis will be based on the most severe clinical histopathology (at diagnostic endometrial sampling or surgery.)

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

  • Women ≥18 years of age.
  • Women with endometrial tissue biopsy-based histopathological diagnosis of EC (any histology, including uterine carcinosarcoma), AEH or EIN.
  • Women whose planned surgical intervention (if any) includes hysterectomy, D&C, or hysteroscopic resection.
  • Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

排除标准

  • Patient with recurrent and/or previously treated EC.
  • Receipt of preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis prior to study enrollment.
  • Prior hysterectomy.
  • Current known pregnancy diagnosis.
  • Prior or current biopsy and histopathology-proven cervical cancer.
  • The presence of concomitant biopsy and histopathology-proven cervical dysplasia.
  • Any prior pelvic or vaginal radiotherapy.
  • Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years.
  • Chemotherapy within the past 5 years.
  • Prior intervention to treat, or surgery with intent to completely remove, the target pathology for the current diagnosis during the current episode.

结局指标

主要结局

Detection of endometrial cancer and precancer

时间窗: 4 months

To provide vaginal fluid specimens to Exact Sciences Corporation to allow for additional research and development of a screening device for the detection of endometrial cancer and endometrial hyperplasia with atypia.

次要结局

未报告次要终点

研究者

发起方
Innovis LLC
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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