Clinical trial · Interventional
Lavage of the Uterine Cavity for Diagnosis of Ovarian Cancer
Lavage of the Uterine Cavity for Diagnosis of Ovarian Carcinomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to low accrual
Summary
Brief summary (as posted)
The goal of this project is to develop a minimally invasive test to detect ovarian cancer, by searching for mutations from the tumor in samples obtained from the cervix (Pap smears), and from the uterus (uterine lavage) in participants with advanced ovarian cancer and in participants with increased risk of ovarian cancer due to inherited mutations, such as BRCA or BRCA2 (among others). Pap smear and uterine lavage samples will be collected while the participant is under anesthesia for planned debulking surgery. A novel, highly sensitive and accurate technique, Crispr-Duplex sequencing, will be used to detect tumor associated mutations in TP53 (the most commonly mutated gene in ovarian cancer) within these samples. These results will be compared to sequencing results in the tumor itself for comparison, and Pap and uterine lavage will be compared to each other to determine the optimal test. Ultimately, the goal is to use the results of this study to plan a larger study including women without cancer who are at either increased risk or normal risk of ovarian cancer, for use in early detection.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Grade Ovarian Serous Adenocarcinoma | Ovarian High Grade Serous Adenocarcinoma | ALIAS | 0.90 |
| Stage IIIA1 Ovarian Cancer AJCC v8 | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA2 Ovarian Cancer AJCC v8 | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Ovarian Cancer AJCC v8 | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Ovarian Cancer AJCC v8 | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Ovarian Cancer AJCC v8 | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Ovarian Cancer AJCC v8 | Malignant Ovarian Neoplasm |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Lavage | Device | — | UNRESOLVED |
| Pap Smear | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (pap smear, uterine lavage, tumor sample)
- description
- Participants undergo pap smear, uterine lavage, and collection of tumor sample during a planned surgery. DNA is then extracted from the samples and sequenced for TP53 mutations using Crispr-Duplex sequencing.
- interventionNames
- Other: Biospecimen Collection
- Other: Laboratory Biomarker Analysis
- Device: Lavage
- Other: Pap Smear
Primary outcomes (1)
- measure
- 20 Ovarian Cancer Participants With Detection of Associated TP53 Mutation in Uterine Lavage
- timeFrame
- A single point in time after sample collection, no follow-up of participants is done
- description
- In participants with ovarian cancer, we compared the detection of TP53 mutations in the uterine lavage specimen compared to the ovarian cancer.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * With suspected advanced ovarian cancer or genetic predisposition to malignant neoplasm of the ovary * Planned surgery * Have a uterus and no history of tubal occlusion Exclusion Criteria: * Unable to speak English * Unable to provide informed consent * Prior hysterectomy
References
Publications (0)
Data not yet available