Vaginal Fluid Collection for Detection of Endometrial Cancer

NCT06294886 | Recruiting

• 1 other identifier: Innovis RD-2401
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Screening test to detect endometrial cancer and precancer DIAGNOSTIC_TEST

The device is designed to detect DNA biomarkers for cancer in cells shed from the lining of the uterus into vaginal fluid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovis LLC: lead

Study Sites (1)

Trials365

Shreveport, Louisiana, 71118, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Vaginal fluid samples

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Gregg S Britt

  Innovis LLC

  STUDY DIRECTOR

Central Study Contacts

Wallis Blumm

CONTACT

9172082989; wblumm@innovis.net

Gregg S Britt

CONTACT

3103863000; gbritt@innovis.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: February 19, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)