Early detection of ovarian cancer using blood tests in low-risk women

Use of CA125 and Complementary Biomarkers for the Early Detection of Ovarian Cancer in Low Risk Women

This study is testing if a combination of four blood tests can help find ovarian cancer earlier in women who are considered low-risk.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 8000 (estimated)
• Ages: 50 Years to 74 Years
• Sex: Female
• Sponsor: M.D. Anderson Cancer Center (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 12 sites (Miami, Florida and 11 other locations)
• Trial ID: NCT00539162 on ClinicalTrials.gov

What this trial studies

This clinical research evaluates a method involving four blood tests—CA-125, HE4, HE4 antigen autoantibody complexes, and osteopontin—to improve early detection of ovarian cancer in low-risk women. Participants will undergo blood draws and complete questionnaires about their medical history and symptoms. The results from these tests will be combined into a Risk of Ovarian Cancer-2 (ROCA2) score to determine if further testing is necessary. The study aims to address the lack of effective screening methods for ovarian cancer in this population.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal women aged 50 to 75 who have at least one ovary and are cancer-free.

Not a fit: Patients who have had both ovaries removed or those with active non-ovarian malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to earlier detection of ovarian cancer, improving treatment outcomes for women.

How similar studies have performed: Other studies have explored similar blood test approaches for cancer detection, showing promising results, but this specific combination is relatively novel.

Eligibility criteria

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.

Where this trial is running

Miami, Florida and 11 other locations

• Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine — Miami, Florida, United States (RECRUITING)
• John Stoddard Cancer Center — Des Moines, Iowa, United States (RECRUITING)
• University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
• Carol G. Simon Cancer Center / Atlantic Health — Morristown, New Jersey, United States (RECRUITING)
• University of Rochester Medical Center — Rochester, New York, United States (RECRUITING)
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (RECRUITING)
• Women's and Infant's Hospital — Providence, Rhode Island, United States (RECRUITING)
• The University of Texas at Austin — Austin, Texas, United States (ACTIVE_NOT_RECRUITING)
• University of Texas (UT) Southwestern Medical Center — Dallas, Texas, United States (ACTIVE_NOT_RECRUITING)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
• Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA) — Houston, Texas, United States (RECRUITING)
• UT Health Science Center San Antonio — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Denise Nebgen, MD, PHD — M.D. Anderson Cancer Center
• Study coordinator: Gwen H. Corrigan

Conditions: Ovarian Cancer, CA 125 Algorithm, Cancer Detection, Questionnaire, Survey