Recruiting

Observational Study

Sponsor:

Innovis LLC

Code:

NCT06294886

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Screening test to detect endometrial cancer and precancer

Study Details

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

Study ID

NCT06294886

Start date

Feb 19, 2024

Status verified date

Mar, 2024

Completion date

Jun 1, 2024

Anticipated

Primary completion date

Jun 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Interventions

Screening test to detect endometrial cancer and precancer

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

Primary outcome measure

  • Detection of endometrial cancer and precancer [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Locations

Trials365

Recruiting

Shreveport, Louisiana, United States, 71118

Contacts

Principal Investigator:

Destin Black, MD

More Information

Sponsor

Innovis LLC

Last update posted

Mar 7, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Innovis LLC on 2024-03-07.