Recruiting NCT07544680
Endometrial Cancer Vaginal Fluid Specimen Collection Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Abnormal Uterine Bleeding (AUB), Endometrial Cancer, Atypical Endometrial Hyperplasia, Endometrial Hyperplasia With Atypia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Endometrial Cancer Vaginal Fluid Specimen Collection Study: "ENVISION"
Overview
This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.
Primary outcome measures
- Collection of clinically characterized vaginal fluid specimens [Time frame: Within 90 days of enrollment.]
- Clinical data for biomarker assay development and evaluation [Time frame: Within 90 days of enrollment]
- Collection devices for detection [Time frame: Within 90 days of enrollment]
- Characterization of endometrial neoplasia, other neoplasms, or underlying causes [Time frame: Within 90 days of enrollment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 4 centers
- Physical Care Clinical Research — Sarasota
- MaineHealth — Scarborough
- Murfreesboro Medical Clinic — Murfreesboro
- IC Research — Murfreesboro
Identifiers
NCT: NCT07544680 · 2024-01