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Endometriosis is a complex, heterogeneous disease that may present inconsistently across women. Using disease-specific biomarkers and advanced biostatistics, DotLab is developing a biomarker test to confirm the presence of endometriosis.This is a multi-center, prospective, observational, minimal risk study in women undergoing laparoscopy, laparotomy or other pelvic surgical procedure for endometriosis, infertility or another benign gynecological indication. Participants will undergo 2 study visits for collection of blood and saliva and completion of study questionnaires.
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical validity | Performance of a microRNA (miRNA)-based assay compared to visual inspection during surgery for the diagnosis of active endometriosis | From date of first sample collection to surgery, up to 3 weeks |
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Inclusion Criteria:
Participant is willing and able to provide written informed consent.
Participant is willing and able to provide up to 50 mL of blood via venipuncture and comply with all other study and sample collection procedures.
Participant is a female aged 18 through 49 years (inclusive).
Participant is scheduled to undergo:
Exclusion Criteria:
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Women of reproductive age who have been referred to surgery for suspected endometriosis and other benign gynecological indications.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Hospital | Palo Alto | California | 94031 | United States | ||
| Center for Special Minimally Invasive & Robotic Surgery |
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Blood and saliva
| Woodside |
| California |
| 94061 |
| United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| Christiana Care | Newark | Delaware | 19713 | United States |
| RAD Fertility | Newark | Delaware | 19713 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Academia of Women's Health and Endoscopic Surgery | Atlanta | Georgia | 30328 | United States |
| Northwestern Medicine | Chicago | Illinois | 60611 | United States |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| The Advanced Gynecologic Surgery Institute | Park Ridge | Illinois | 60068 | United States |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Rutgers Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
| NewYork-Presbyterian / Columbia University Medical Center | New York | New York | 10019 | United States |
| University Hospitals | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Penn State Health | Hershey | Pennsylvania | 17033 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| UT Austin | Austin | Texas | 78712 | United States |
| Seattle Reproductive Medicine | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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