Clinical trial · Interventional
Uterine Lavage to Detect Ovarian Cancer Risk
Collection of Uterine Lavage in High-Risk Patients as a Potential Biomarker for Ovarian Cancer Risk
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
This clinical trial develops a non-surgical approach using uterine lavage samples to screen for progression to ovarian cancer in high-risk patients carrying BRCA mutations. Women with inherited mutations in the BRCA1 and BRCA2 genes (BRCA carriers) have a much higher lifetime risk of developing ovarian cancer. Currently there are no effective ovarian cancer screening or early detection tests for BRCA carriers. Uterine lavage is a procedure that uses saline to rinse and collect cells from the fallopian tube. Molecular analysis of these samples may help proactively detect genetic alterations that are indicative of progression to ovarian cancer in women with BRCA mutations.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA Hereditary Ovarian Carcinoma | BRCA Hereditary Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Fallopian Tube High Grade Serous Adenocarcinoma | Fallopian Tube High Grade Serous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian High Grade Serous Adenocarcinoma | Ovarian High Grade Serous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Primary Peritoneal High Grade Serous Adenocarcinoma | Primary Peritoneal High Grade Serous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Archive Sample | Procedure | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
| Uterine Lavage | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening (uterine lavage)
- description
- Patients undergo uterine lavage prior to their standard of care risk-reduction surgery and uterine lavage samples undergo molecular analysis on study.
- interventionNames
- Other: Uterine Lavage
- Procedure: Archive Sample
- Other: Survey Administration
Primary outcomes (4)
- measure
- TP53 mutation burden (MB)
- timeFrame
- Up to 2 years
- description
- Will compare TP53 MB in lavages of women with and without serous tubal intraepithelial carcinoma/high grade serous carcinoma (HGSC).
- measure
- Correlation of TP53 mutation burden (MB) in lavages with known HGSC risk factors
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \> 18 years of age * Have a pathogenic BRCA1 or BRCA2 germline variant * Planned risk-reduction surgery * Presence of uterus and at least one fallopian tube Exclusion Criteria: * Prior tubal ligation * Prior history of known ovarian or endometrial cancer
References
Publications (0)
Data not yet available