Vaginal Fluid Collection for Detection of Endometrial Cancer

Description

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.

Conditions

Endometrial Cancer

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Study Overview

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Study Details

Study overview

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.

Vaginal Fluid Collection Study for Endometrial Cancer Test Research and Development

Vaginal Fluid Collection for Detection of Endometrial Cancer

Condition
Endometrial Cancer
Intervention / Treatment

-

Contacts and Locations

Shreveport

Trials365, Shreveport, Louisiana, United States, 71118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Women ≥18 years of age.
  • 2. Women with endometrial tissue biopsy-based histopathological diagnosis of EC (any histology, including uterine carcinosarcoma), AEH or EIN.
  • 3. Women whose planned surgical intervention (if any) includes hysterectomy, D\&C, or hysteroscopic resection.
  • 4. 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.
  • 1. Patient with recurrent and/or previously treated EC.
  • 2. Receipt of preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis prior to study enrollment.
  • 3. Prior hysterectomy.
  • 4. Current known pregnancy diagnosis.
  • 5. Prior or current biopsy and histopathology-proven cervical cancer.
  • 6. The presence of concomitant biopsy and histopathology-proven cervical dysplasia.
  • 7. Any prior pelvic or vaginal radiotherapy.
  • 8. Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years.
  • 9. Chemotherapy within the past 5 years.
  • 10. Prior intervention to treat, or surgery with intent to completely remove, the target pathology for the current diagnosis during the current episode.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Innovis LLC,

Gregg S Britt, STUDY_DIRECTOR, Innovis LLC

Study Record Dates

2024-06-01