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The primary objective of this study is to obtain de-identified vaginal fluid specimens from participants with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia or endometrial intraepithelial neoplasia (EIN).
The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of EC, AEH and EIN.
For participants providing written informed consent to participate in the study, samples of vaginal fluid will be obtained by the Principal Investigator (PI) during a pelvic examination. All vaginal fluid samples will be collected ≥7 days after the endometrial biopsy and prior to initiating any therapeutic interventions including surgery, chemotherapy, radiation or hormonal therapy PIs will be provided with multiple, individually packaged Copan eNat® sterile sample collection kits including a swab and a transport tube containing a stabilizer and preservative medium as well as a pre-addressed shipping container and single-use tubes of sterile saline solution After vaginal fluid sample collection, the swab will be inserted into the tube for storage and subsequent shipping to the Sponsor's designated laboratory. The samples can be stored at ambient temperature and should be shipped to the designated laboratory within 24 hours of collection. Site(s) will provide the Sponsor with de-identified endometrial biopsy histopathology report and post-surgery histopathology report (if any) confirming the histopathological diagnosis of EC, AEH or EIN. The final diagnosis will be based on the most severe clinical histopathology (at diagnostic endometrial sampling or surgery.)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening test to detect endometrial cancer and precancer | Diagnostic Test | The device is designed to detect DNA biomarkers for cancer in cells shed from the lining of the uterus into vaginal fluid |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of endometrial cancer and precancer | To provide vaginal fluid specimens to Exact Sciences Corporation to allow for additional research and development of a screening device for the detection of endometrial cancer and endometrial hyperplasia with atypia. | 4 months |
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Inclusion Criteria:
Women ≥18 years of age.
Women with endometrial tissue biopsy-based histopathological diagnosis of EC (any histology, including uterine carcinosarcoma), AEH or EIN.
Women whose planned surgical intervention (if any) includes hysterectomy, D&C, or hysteroscopic resection.
Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
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Exclusion Criteria:
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The study will enroll women ≥18 years of age with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia, or endometrial intraepithelial neoplasia (EIN) presenting for management of their endometrial pathology.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wallis Blumm | Contact | 9172082989 | wblumm@innovis.net | |
| Gregg S Britt | Contact | 3103863000 | gbritt@innovis.net |
| Name | Affiliation | Role |
|---|---|---|
| Gregg S Britt | Innovis LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trials365 | Recruiting | Shreveport | Louisiana | 71118 | United States |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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Vaginal fluid samples
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |