Clinical trial · Observational
Natera Ovarian Cancer Detection Assay
Prospective Collection of Samples for Development of the Natera Ovarian Cancer Detection Assay
NCT03485651CI-TRIAL-00043243terminatedClinicalTrials.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)
The purpose of this study is to enroll participants who present with an adnexal mass on imaging to develop a non-invasive ovarian cancer assay to distinguish between malignant and benign masses. The study will collect blood, tissue, and health information from these individuals.
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 |
|---|---|---|---|
| Adnexal Mass | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Compare ctDNA from benign ovarian masses and confirmed ovarian cancers
- timeFrame
- Up to 60 months or 5 years
- description
- Examine ctDNA between benign ovarian masses and confirmed ovarian cancer cases (based on tumor pathology report). The purpose of this outcome is to determine whether cfDNA could be used to develop a non-invasive ovarian cancer assay to distinguish between malignant and benign masses.
Secondary outcomes (1)
- measure
- Determine the relationship between quantity of ctDNA and standard prognostic criteria
- timeFrame
- Up to 60 months or 5 years
- description
- Examine quantity of ctDNA and standard prognostic criteria such as tumor grade, histology and stage of cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Presenting to clinic with adnexal mass suspicious of ovarian, fallopian tube, or peritoneal cancer on imaging * Must be planning surgical resection or biopsy * Must be treatment naïve * Must be 18 years or older * Able to understand and sign a written informed consent document * Able to provide 40mL of blood (at least 20mL) for each blood draw Exclusion Criteria: * Prior removal of either ovary for any reason * Currently pregnant * Blood transfusion within 3 months of study enrollment * History of bone marrow or organ transplant * Prior history and treatment for any malignancy, with exception of previously treated non-melanoma skin cancer. * A medical condition that would place subject at risk as a result of the blood donation, including but not limited to bleeding disorders, chronic infectious disease, emphysema or serious anemia
References
Publications (0)
Data not yet available
No reference posted for this study.