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This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants undergoing clinical evaluation for AUB | ||
| Cohort 2 | Participants diagnosed with EC or AEH/EIN |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Within 90 days of enrollment |
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Inclusion Criteria
Cohort 1 Participants:
Cohort 2 Participants:
Exclusion Criteria
Additional for Cohort 1:
Additional for Cohort 2:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Trial Manager | Contact | 608-982-1588 | ENVISION_Study_Info@exactsciences.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Murfreesboro Medical Clinic | Recruiting | Murfreesboro | Tennessee | 37130 | United States |
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.
Data will be available from 2 years and ending 4 years after publication.
Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/IEC approvals or waivers as applicable to conduct research
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| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| D016889 | Endometrial Neoplasms |
| D004714 | Endometrial Hyperplasia |
| D011230 | Precancerous Conditions |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |