Vaginal Fluid Collection for Detection of Endometrial Cancer

Summary

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.

Eligibility

Inclusion 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.

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Exclusion Criteria:

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.

Conditions2

Locations1 site

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