A Randomized Controlled Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epithelial Ovarian Cancer
- Sponsor
- Fred Hutchinson Cancer Center
- Enrollment
- 854
- Locations
- 5
- Primary Endpoint
- Positive predictive value of each of the two screening protocols
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The Novel Markers Trial will compare the safety, feasibility and effectiveness of two different epithelial ovarian cancer screening strategies that use CA125 and add HE4 as either a first or second line screen. This study is the next step in a larger research effort to develop a blood test that can be used as a screening method for the early detection of epithelial ovarian cancer.
Detailed Description
Epithelial ovarian cancer (EOC) is usually lethal unless it is diagnosed at an early stage, thus early detection is likely to play an important role in reducing its mortality. Within the Ovarian Specialized Programs of Research Excellence Pacific Ovarian Cancer Research Consortium (POCRC) researchers have been working for a decade to discover, develop, and validate biomarkers (proteins or substances found in blood) that could help save lives by detecting EOC early. During the last five years several biomarkers, including CA125, have been evaluated for their ability to detect EOC at an earlier stage. The best markers will now be studied in a new randomized controlled trial of ovarian cancer screening.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Risk Group 1, Women ages 25 - 80:
- •The subject has tested positive for a deleterious germ line mutation in BRCA1 or BRCA
- •Risk Group 2, Women ages 35 - 80, Pedigree conditions can be satisfied by multiple primary cancers in the same person:
- •The subject has a personal history of breast cancer diagnosed before or at age
- •OR the subject has a personal history of bilateral breast cancer
- •OR the subject has one first-degree relative with breast cancer diagnosed before or at age
- •OR the subject has two breast cancers in the first or second degree relatives, same lineage, with at least one breast cancer diagnosed before or at age
- •OR the subject has three or more first or second degree relatives, same lineage, with breast cancer diagnosed at any age.
- •OR The family contains at least one ovarian cancer diagnosed at any age in the first or second degree relatives.
- •OR the subject is of Ashkenazi ancestry and has had breast cancer diagnosed at any age.
Exclusion Criteria
- •Removal of both ovaries for any reason.
- •History of ovarian, fallopian tube cancer or peritoneal carcinomatosis.
- •Currently pregnant.
- •Unable or unwilling to provide informed consent.
- •Unwilling to provide the name of a physician.
- •Unwilling to sign informed consent and/or medical records release form.
- •Current untreated malignancy (other than non-melanoma skin cancer).
- •Currently receiving adjuvant chemotherapy or radiation therapy for cancer (except tamoxifen or aromatase inhibitors +/- lupron). Patients who are being treated may enroll 3 months after completion of last treatment.
- •Intraperitoneal surgery within the last 3 months (laparoscopy or laparotomy).
- •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.
Outcomes
Primary Outcomes
Positive predictive value of each of the two screening protocols
Time Frame: From first screen through remaining study period
Calculated as number of women with a significant lesion identified at a protocol-indicated procedure divided by number of women with protocol-indicated surgical procedures performed.
Secondary Outcomes
- Screening compliance(From first screen through remaining study period)
- Cancer related distress and health related quality of life(At baseline, each screen, 6 weeks post-surgery to remove remaining ovary/ies, and 6 months after post-surgical assessment)