Abnormal Uterine Bleeding (AUB)ENVISIONNCT07544680
Endometrial Cancer Vaginal Fluid Specimen Collection Study
An observational study of Abnormal Uterine Bleeding (AUB) and Endometrial Cancer, run by Exact Sciences Corporation at 5 sites in United States.
Trial summary
This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abnormal Uterine Bleeding (AUB), Endometrial Cancer, Atypical Endometrial Hyperplasia
- How many people
- 4,200 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 Mar 2026to 24 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving routine clinical care within participating primary care, gynecology, oncology, and Veterans Affairs health systems across rural, urban, and suburban regions of the United States.
Who may be able to join
- 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
Who cannot join
- 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:
Show all 16Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
National Research Center - Frisco
Frisco, Texas, 75034
Murfreesboro Medical Clinic
Murfreesboro, Tennessee, 37130
IC Research
Murfreesboro, Tennessee, 37132
Physical Care Clinical Research
Sarasota, Florida, 34249
MaineHealth
Scarborough, Maine, 04070
About this study
Official title: Endometrial Cancer Vaginal Fluid Specimen Collection Study: "ENVISION"
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
- Abnormal Uterine Bleeding (AUB), Endometrial Cancer, Atypical Endometrial Hyperplasia, Endometrial Hyperplasia With Atypia, Endometrial Intraepithelial Neoplasia
- Keywords
- Abnormal Uterine Bleeding (AUB), Endometrial Cancer (EC), Atypical Endometrial Hyperplasia (AEH), Endometrial Hyperplasia with Atypia, Endometrial Intraepithelial Neoplasia (EIN), Precancerous Conditions, Post-Menopausal Bleeding, Specimen Collection, Sample Collection, in vitro diagnostic (IVD) devices
- Medical subject headings
- Metrorrhagia, Endometrial Neoplasms, Endometrial Hyperplasia, Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants undergoing clinical evaluation for AUB | |
| Cohort 2 | Participants diagnosed with EC or AEH/EIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of clinically characterized vaginal fluid specimens
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.
Measured: Within 90 days of enrollment.
Clinical data for biomarker assay development and evaluation
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.
Measured: Within 90 days of enrollment
Collection devices for detection
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.
Measured: Within 90 days of enrollment
Characterization of endometrial neoplasia, other neoplasms, or underlying causes
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.
Measured: Within 90 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start10 Mar 2026
- Primary completion24 Apr 2028 (estimated)
- Study completion24 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine Bleeding (AUB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544680
- Sponsor's protocol ID
- 2024-01
- Acronym
- ENVISION
- Status last verified
- Jul 2026
- First submitted
- 31 Mar 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include test, tables, figures, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable), and the clinical study report (when applicable) will also be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Cancer Vaginal Fluid Specimen Collection Study: "ENVISION"
- ClinicalTrials.gov ID
- NCT07544680
- Acronym / sponsor ID
- ENVISION / 2024-01
- Conditions
- Abnormal Uterine Bleeding (AUB), Endometrial Cancer, Atypical Endometrial Hyperplasia, Endometrial Hyperplasia With Atypia, Endometrial Intraepithelial Neoplasia
- Keywords
- Abnormal Uterine Bleeding (AUB), Endometrial Cancer (EC), Atypical Endometrial Hyperplasia (AEH), Endometrial Hyperplasia with Atypia, Endometrial Intraepithelial Neoplasia (EIN), Precancerous Conditions, Post-Menopausal Bleeding, Specimen Collection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,200 participants (estimated)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 24 Apr 2028 (estimated)
- Study completion
- 24 Apr 2028 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants undergoing clinical evaluation for AUB |
| Cohort 2 | – | –Participants diagnosed with EC or AEH/EIN |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving routine clinical care within participating primary care, gynecology, oncology, and Veterans Affairs health systems across rural, urban, and suburban regions of the United States.
Key inclusion criteria (8 listed)
- 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)
- Age ≥ 18 years
- Newly diagnosed, biopsy-confirmed EC or AEH/EIN
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include test, tables, figures, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable), and the clinical study report (when applicable) will also be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormal Uterine Bleeding (AUB) and Endometrial Cancer, run by Exact Sciences Corporation at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of clinically characterized vaginal fluid specimens (time frame: Within 90 days of enrollment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 3 Nov 2026.