NCT07544680 · Exact Sciences Corporation
Endometrial Cancer Vaginal Fluid Specimen Collection Study
(ENVISION)
What this study is about
This is a conducted at multiple hospitals, forward-looking, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.
View original scientific description
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.
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.
Clinical data for biomarker assay development and evaluation
Time frame: Within 90 days of enrollment
Clinical information will be collected as part of routine study participation and used to describe the study population and support research analyses. Data will be used in aggregate to contextualize research findings and inform future assay development.
Collection devices for detection
Time frame: Within 90 days of enrollment
Specimens will be collected using swab-based collection devices intended solely for specimen collection. These devices do not provide diagnostic results and are not used for clinical decision-making.
Characterization of endometrial neoplasia, other neoplasms, or underlying causes
Time frame: Within 90 days of enrollment
Characterization will be based on existing clinical assessments and diagnoses obtained through standard medical care. The study does not establish diagnostic criteria or endpoints and is intended for research and development purposes only.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Murfreesboro, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations