Clinical trial · Interventional
Assess Cancer in Ovarian Tumors With Biomarkers.
Whole Blood Collection Protocol For Ovarian Assay Clinical Trial In Women With Ovarian Tumors
- 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)
Purpose The OvaRI assay clinical trial is directed at evaluating a novel proteomics-based blood test. This test is for a physician to use towards differentiating benign from malignant ovarian tumors prior to surgical intervention. Tools that can better triage women with an ovarian tumor are needed. It has been shown that women with ovarian cancer who are referred to gynecologic oncologists have better outcomes. The primary objective of this study is to demonstrate that the OvaRl assay (test) improves the preoperative identification of ovarian cancer in patients with a ovarian tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Tumor | Ovarian Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Draw | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of actual ovarian cancer cases among OvaRl positive patients is higher than the proportion of actual ovarian cancer cases among referred patients.
Secondary outcomes (1)
- measure
- Evaluate OvaRl assay plus standard clinical practice.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is female and age 18 years or older 2. Subject has a level of understanding sufficient to agree to all tests required by the protocol, must be considered reliable and must be able to cooperate with study procedures 3. Subject signs approved written informed consent prior to any study procedures being performed 4. Subject must agree to venipuncture 5. Subject has a documented adnexal tumor with planned surgical intervention Exclusion Criteria: 1. Women under age 18 2. No planned surgical intervention 3. Decline phlebotomy 4. Diagnosis of malignancy in the last 10 years, with the exception of a non-melanoma skin cancer
References
Publications (0)
Data not yet available