Clinical trial · Interventional
Detection of Tumor Associated Cell-free DNA in Peritoneal Fluid Obtained by Culdocentesis
NCT02441140CI-TRIAL-00044939terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual
Summary
Brief summary (as posted)
This research study is studying a possible test which may help doctors diagnose women with ovarian 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 |
|---|---|---|---|
| Stage III Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood collection | Procedure | — | UNRESOLVED |
| Chromopertubation | Procedure | — | UNRESOLVED |
| Culdocentesis | Procedure | — | UNRESOLVED |
| Tissue collection | Procedure | — | UNRESOLVED |
| Vaginal Swab | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Culdocentesis
- description
- * Patients with known or highly likely ovarian cancer (i.e. highly elevated CA-125, ascites, pelvic mass) scheduled for cytoreductive surgery will be identified during preoperative consultation and offered participation in the study. * During Surgery: * Blood Collection * Vaginal Swab * Chromopertubation * Culdocentesis * Tissue Collection
- interventionNames
- Procedure: Culdocentesis
- Procedure: Vaginal Swab
- Procedure: Chromopertubation
- Procedure: Blood collection
- Procedure: Tissue collection
Primary outcomes (1)
- measure
- Number of completed peritoneal fluid collection by culdocentesis after chromopertubation as an assessment of feasibility of peritoneal fluid collection in women with ovarian cancer.
- timeFrame
- At the time of surgery
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age ≥ 18 * Able to give informed consent * Scheduled for surgery at Brigham and Women's Hospital for known or highly suspected Stage III or IV ovarian cancer (i.e. elevated CA-125 with a pelvic mass, ascites, and carcinomatosis) * Post-menopausal or negative urine and/or blood pregnancy test * Measurable disease on preoperative imaging Exclusion Criteria: * Male * Age \< 18 * Unable to give informed consent * Not planned for surgical intervention * Active malignancy other than ovarian cancer * Prior bilateral tubal ligation or hysterectomy (as this would prevent chromopertubation) * Known or suspected active pelvic infection * Pregnancy * No measurable disease or suspected Stage I or II ovarian cancer on preoperative imaging
References
Publications (0)
Data not yet available
No reference posted for this study.