Collecting vaginal fluid to detect endometrial cancer
Vaginal Fluid Collection Study for Endometrial Cancer Test Research and Development
This study is trying to see if collecting vaginal fluid from women with endometrial cancer or related conditions can help create a new test for earlier detection and better treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Innovis LLC Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Shreveport, Louisiana) |
| Trial ID | NCT06294886 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect de-identified vaginal fluid samples from women diagnosed with endometrial cancer, atypical endometrial hyperplasia, or endometrial intraepithelial neoplasia. Participants will provide samples during a pelvic examination, which will be sent to a designated laboratory for analysis. The goal is to develop a new molecular diagnostic test for detecting these conditions, enhancing early diagnosis and treatment options.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a confirmed histopathological diagnosis of endometrial cancer, atypical endometrial hyperplasia, or endometrial intraepithelial neoplasia.
Not a fit: Patients with recurrent or previously treated endometrial cancer, or those who have undergone prior hysterectomy, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more accurate and non-invasive method for detecting endometrial cancer and its precursors.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel method for detection.
Eligibility criteria
Show full inclusion / exclusion criteria
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. - 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.
Where this trial is running
Shreveport, Louisiana
- Trials365 — Shreveport, Louisiana, United States (Recruiting)
Study contacts
- Study coordinator: Wallis Blumm
- Email: wblumm@innovis.net
- Phone: 9172082989
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.