Clinical trial · Interventional
Use of CA125 and Complementary Biomarkers for the Early Detection of Ovarian Cancer in Low Risk Women
NCT00539162CI-TRIAL-00110666recruitingN/AClinicalTrials.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 goal of this clinical research study is to find out if combining a standard blood test (CA-125) that checks for ovarian cancer with other blood tests that check for related tumor markers may be helpful in the early detection of ovarian cancer in women who are at low risk. Tumor markers are substances in the blood that may be related to ovarian cancer.
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 |
|---|---|---|---|
| Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CA 125 Analysis
- description
- Experimental: CA-125 Analysis Experimental: CA-125, HE4, and Osteopontin bio-marker analysis. Participants will have blood (3-4 tablespoons) drawn for CA-125 and other tumor markers. Depending on CA-125 level and other tumor markers: Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers in 1 year. Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers in 3 months, OR Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers, and a transvaginal ultrasound in 6 weeks +/- 2 weeks.
- interventionNames
- Behavioral: Questionnaire
Primary outcomes (1)
- measure
- Rate of increase in CA 125 levels and other tumor markers over time
- timeFrame
- Based on CA-125 level, 3 options will result: 1) re-draw blood (CA-125) in 1 year, 2) re-draw blood (CA-125) in 3 months), or 3) re-draw blood (CA-125) AND TVUS in 6 weeks +/- 2 weeks.
- description
- \[Time Frame: Based on CA-125 level and other tumor markers, 3 options will result: 1) re-draw blood (CA-125 and other tumor markers) in 1 year, 2) re-draw blood (CA-125 and other tumor markers) in 3 months, or 3) re-draw blood (CA-125 and other tumor markers) and TVUS in 6 weeks +/- 2 weeks.\]
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female, \>/= 50 years old or less than 75 years old. 2. Postmenopausal (\>/= 12 months amenorrhea). 3. Have at least one ovary. 4. Cancer-free and have not received any chemotherapy or radiation therapy for \>/=12 months prior to enrolling on this study. 5. Willingness to return for CA 125 blood tests annually or earlier if indicated. 6. Willingness to return to undergo transvaginal ultrasound if indicated. 7. Women need to provide the name of a gynecologist or qualified healthcare professional willing to provide appropriate follow-up care if indicated Exclusion Criteria: 1. Female: Less than 50 years old or older than 75 years at the time of enrollment. 2. Psychiatric or psychological or other conditions which prevent a fully informed consent. 3. Prior removal of both ovaries. 4. Active non-ovarian malignancy. 5. Women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for \>12 months. If they are on SERMS (i.e. tamoxifen or aromatase inhibitors) they will not be excluded. Women maybe undergoing or have had treatment \<12 months prior to study entry for basal cell carcinoma only. 6. High risk for ovarian cancer due to familial predisposition as defined by the following: a. Known mutation in BRCA1 of BRCA2. b. Two 1st or 2nd degree relatives of same lineage who have: two ovarian cancers; one ovarian cancer \& one pre-menopausal breast cancer; two pre-menopausal breast cancers; one pre-menopausal \& one post-menopausal breast cancer. (These conditions can also be met using the patient and one 1st or 2nd degree female relative.) c. Ashkenazi Jewish descent with one 1st degree or two 2nd degree relatives with pre-menopausal breast or ovarian cancer or participant has had pre-menopausal breast cancer. d. 1st or 2nd degree male relative with breast cancer diagnosed at any age. (First degree relative defined as children, siblings and parents. Second degree relative defined as half-siblings, aunts, uncles, nieces, nephews, grandparents, and grandchildren.) 7. Hereditary Nonpolyposis Colorectal Cancer (HNPCC)/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria.
References
Publications (1)
- DERIVEDHan CY, Lu KH, Corrigan G, Perez A, Kohring SD, Celestino J, Bedi D, Bedia E, Bevers T, Boruta D, Carlson M, Holman L, Leeds L, Mathews C, McCann G, Moore RG, Schlumbrecht M, Slomovitz B, Tobias D, Williams-Brown Y, Bevers MW, Liu J, Gornet TG, Handy BC, Lu Z, Bedia JS, Skates SJ, Bast RC Jr. Normal Risk Ovarian Screening Study: 21-Year Update. J Clin Oncol. 2024 Apr 1;42(10):1102-1109. doi: 10.1200/JCO.23.00141. Epub 2024 Jan 9. PMID 38194613