Vaginal Fluid Collection for Detection of Endometrial Cancer

Vaginal Fluid Collection Study for Endometrial Cancer Test Research and Development

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.

Study Overview

• Status: Recruiting
• Conditions: Endometrial Cancer
• Intervention / Treatment: Diagnostic test: Screening test to detect endometrial cancer and precancer

Detailed Description

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.)

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Gregg S Britt; Phone Number: 3103863000; Email: gbritt@innovis.net
• Study Contact Backup: Name: Wallis Blumm; Phone Number: 9172082989; Email: wblumm@innovis.net

Study Locations

• United States
  • Louisiana
    • Shreveport, Louisiana, United States, 71118
      • Recruiting
      • Trials365
      • Principal Investigator: Destin Black, MD
      • Contact: Jen Cory; Phone Number: 318-408-1198; Email: j.cory@trials365.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study will enroll women ≥18 years of age with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia, or endometrial intraepithelial neoplasia (EIN) presenting for management of their endometrial pathology.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of endometrial cancer and precancer	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.	4 months

Collaborators and Investigators

• Sponsor: Innovis LLC
• Collaborators: Exact Sciences Corporation
• Investigators: Study Director: Gregg S Britt, Innovis LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometrial Neoplasms
• Other Study ID Numbers: Innovis RD-2401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No