Clinical trial · Observational
Endometrial Cancer Vaginal Fluid Specimen Collection Study
Endometrial Cancer Vaginal Fluid Specimen Collection Study: "ENVISION"
NCT07544680CI-TRIAL-00124051ENVISIONrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abnormal Uterine Bleeding (AUB) | — | UNRESOLVED | — |
| Atypical Endometrial Hyperplasia | Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia | ALIAS | 0.90 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Hyperplasia With Atypia | Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia | ALIAS | 0.90 |
| Endometrial Intraepithelial Neoplasia | Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1
- description
- Participants undergoing clinical evaluation for AUB
- label
- Cohort 2
- description
- Participants diagnosed with EC or AEH/EIN
Primary outcomes (4)
- measure
- Collection of clinically characterized vaginal fluid specimens
- timeFrame
- Within 90 days of enrollment.
- description
- Vaginal fluid specimens will be collected during a standard clinical exam using a swab-based collection method. Specimens will be used for research purposes to support the development of biomarker assays. No specific biomarkers or analytical methods are defined as part of this study.
- measure
- Clinical data for biomarker assay development and evaluation
- timeFrame
- Within 90 days of enrollment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria Cohort 1 Participants: * Age ≥ 45 years, OR age ≥ 18 years with at least one risk factor * Diagnosed with abnormal uterine bleeding (AUB) * Planning standard-of-care endometrial tissue sampling to assess for endometrial cancer (EC) or atypical endometrial hyperplasia/endometrial intraepithelial neoplasia (AEH/EIN) Cohort 2 Participants: * Age ≥ 18 years * Newly diagnosed, biopsy-confirmed EC or AEH/EIN * Planning initial management for their endometrial pathology Exclusion Criteria * Prior partial or complete hysterectomy * Current pregnancy * Prior pelvic or vaginal radiotherapy * Chemotherapy within past 5 years (except tamoxifen) * Any condition judged by the Investigator to preclude participation Additional for Cohort 1: * Cancer diagnosis within past 5 years (except non-gynecologic skin cancer) * Current biopsy-proven cervical, vaginal, or vulvar cancer, or lower genital tract dysplasia * Current biopsy-proven endometrial cancer, hyperplasia, or benign polyp * Benign endometrial biopsy within last month Additional for Cohort 2: * Cancer diagnosis other than EC within past 5 years (except non-gynecologic skin cancer) * Prior cervical cancer or biopsy-proven cervical dysplasia * Surgery for recurrent EC * Preoperative neoadjuvant chemotherapy or radiotherapy for current EC * Prior treatment or surgery to remove target pathology during current episode
References
Publications (0)
Data not yet available
No reference posted for this study.