Clinical trial · Observational
Benign Reproductive Tissue Analysis for Endometrial Cancer Markers
Benign Reproductive Tissue Evaluation (BRTE) Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: * Endometrial cancer (cancer of the lining of the uterus) is the most common gynecologic cancer in the United States. * Currently, there are no markers (components of blood and tissue that determine who might be at risk for developing cancer) for endometrial cancer. Objectives: -To see if women who are undergoing hysterectomy are willing to provide blood and tissue samples to help doctors identify markers that would indicate increased risk for developing endometrial cancer. Eligibility: -Women between 35 and 54 years of age who will undergo hysterectomy for a non-cancerous condition, such as uterine fibroids, uterine prolapse, abnormal uterine bleeding, and others at Magee-Women's Hospital in Pittsburgh, Penn. Design: * Patients' medical records are reviewed and patients complete a questionnaire including information on race and ethnic background, education, marital status, family history, height, weight, pregnancy history, smoking history, medication history, history about menstrual periods and menopausal symptoms. * Patients provide blood and urine samples before surgery. * A sample of fat tissue is removed during surgery in patients undergoing abdominal surgery. * Tissue samples from the removed uterus (and ovaries if the ovaries are also removed) are collected and analyzed for markers for endometrial cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hysterectomy | — | UNRESOLVED | — |
| Oophorectomy for Benign Reasons | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Females with ovarian cancer
- description
- Recruited from Magee Women's Hospital
Primary outcomes (4)
- measure
- Feasibility of sampling and recruiting
- timeFrame
- Ongoing
- description
- Successful enrollment of women undergoing benign surgery, surgery because of high risk of ovarian cancer, or surgery because of diagnosed ovarian cancer.
- measure
- Assessing PTEN abnormalities in benign tissue
- timeFrame
- Ongoing
- description
- Histological assessment of PTEN staining in normal endometrial tissues.
- measure
- Optimization of PTEN testing
- timeFrame
- Ongoing
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 54 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * Inclusion criteria include: 18 years of age and older with: * a benign condition for which subject has decided to have a hysterectomy (removal of the uterus), performed through an abdominal incision (open procedure) or through a laparoscope (minimally invasive procedure). The hysterectomy can be performed with or without removal of the tubes, ovaries or cervix. * a benign cyst on the ovary(s) which subject has decided to have removed, with or without removal of the entire ovary. The surgery will be done with either an abdominal incision (open) or through a laparoscope (minimally invasive procedure). * positive test for the BRCA 1 or 2 gene, which puts subject at an increased risk for breast cancer, and subject has decided to undergo surgery (either with an abdominal incision or through a laparoscope) to remove the uterus, tubes and ovaries, or any combination * diagnosis of ovarian cancer or possible ovarian cancer and subject has been advised to undergo a hysterectomy (removal of the uterus), removal of the tubes and ovaries or any combination, with an abdominal incision or through a laparoscope. EXCLUSION CRITERIA: Evidence on gross examination of the surgically removed uterus that there is a carcinoma invading the myometrium; however, post-operative diagnosis of early endometrial carcinoma will not be a cause for post-hoc exclusion after specimen and data collection. We will exclude women with a previous gynecologic or gastrointestinal cancer. At the discretion of the surgeon, we will exclude women with cancer in whom the study procedures may interfere with clinical management (e.g. staging of the cancer). We will exclude women who had neo-adjuvant chemotherapy and women who underwent chemoprevention of ovarian or breast cancer. We will also exclude women currently wearing an intrauterine device.
References
Publications (0)
Data not yet available