Clinical trial · Observational
Risk of Ovarian Cancer in Patients With a Pelvic Mass
Evaluation of a Multiple Biomarker Assay to Estimate the Risk of Ovarian Cancer in Patients Presenting With a Pelvic Mass.
NCT00315692CI-TRIAL-00005743completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this clinical trial is to evaluate the ability of multiple serum biomarkers to estimate the risk of ovarian cancer in women presenting with pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass).
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 Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarker Assay (CA125 and HE4) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Premenopausal women
- interventionNames
- Device: Biomarker Assay (CA125 and HE4)
- label
- Postmenopausal women
- interventionNames
- Device: Biomarker Assay (CA125 and HE4)
Primary outcomes (1)
- measure
- Cancer vs Benign Disease
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females selected to undergo laparotomy or laparoscopy based on a finding of pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass); * Pre- and post-menopausal women greater than or equal to 18 years of age; * Pelvic mass must be demonstrated by ultrasound * Able to understand and sign Informed Consent Exclusion Criteria: * Treatment for any malignancy (with the exception of non-melanoma skin cancer) within the last five years * Subjects receiving cytotoxic chemotherapies, such as cyclophosphamide or methotrexate * Subjects with previous bilateral oophorectomy * Any subject known to be pregnant
References
Publications (1)
- DERIVEDMoore RG, McMeekin DS, Brown AK, DiSilvestro P, Miller MC, Allard WJ, Gajewski W, Kurman R, Bast RC Jr, Skates SJ. A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol. 2009 Jan;112(1):40-6. doi: 10.1016/j.ygyno.2008.08.031. Epub 2008 Oct 12. PMID 18851871