Clinical Trial to Screen Participants Who Are at High Genetic Risk for Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title: Ovarian Cancer Screening Pilot Trial in High Risk Women

Status Active, not recruiting

Clinical Trial Summary

RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer.

PURPOSE: Screening trial to determine the significance of cancer antigen 125 (CA125) levels in detecting ovarian cancer in participants who have a high genetic risk of developing ovarian cancer.

Clinical Trial Description

OBJECTIVES:

• Determine the feasibility of prospective ovarian cancer screening studies within the Cancer Genetics Network and other NCI ovarian programs for participants who are at high genetic risk for developing ovarian cancer.

• Identify the logistical issues of screening these participants and their solutions within this framework.

• Establish normal ranges and distributions of CA125 values over time within and between high-risk participants, with subclassification by pre- or post-menopausal status, estrogen-replacement therapy usage, and prior prophylactic oophorectomy.

• Estimate the specificity and positive predictive value of the "risk of ovarian cancer algorithm" (ROCA) suitable for designing a definitive trial of screening for ovarian cancer in high-risk participants.

• Establish a longitudinal serum and plasma biorepository for retrospective evaluation of other promising biomarkers with special relevance to inherited ovarian and breast cancer risk.

OUTLINE: This is a multicenter study. Participants with 1 or 2 ovaries are assigned to group A, whereas participants with prior prophylactic bilateral oophorectomy are assigned to group B (closed to accrual as of 10/18/04).

At baseline, participants who are not eligible by breast cancer susceptibility gene (BRCA) mutation criteria or family history criteria undergo a probability of having a BRCA mutation given family history of cancer (BRCAPRO) evaluation. Participants in both groups complete a questionnaire requesting demographic information and a personal and family health history at baseline and a questionnaire requesting hospitalization or cancer diagnosis information after each blood test. Participants in both groups also complete health status questionnaires once every 3 months for 6 months-7 years. Participants undergo blood draws for measurement of CA125 levels once every 3 months for 6 months-7 years. For each CA125 measurement, the risk of ovarian cancer algorithm (ROCA) is calculated.

Group A (1 or 2 ovaries at baseline):

• Participants are assigned to 1 of 2 subgroups based on ROCA.

• Subgroup A1: Participants with normal-risk for ovarian cancer (ROCA less than 1%) continue CA125 screening as above.

• Subgroup A2: Participants with intermediate-risk for ovarian cancer (ROCA more than 1% but less than 10%) or elevated-risk for ovarian cancer (ROCA more than 10%) undergo transvaginal sonography (TVS). Participants with elevated-risk undergo an additional blood draw for a confirmatory CA125 level prior to TVS. Participants with normal TVS continue CA125 screening as above. Participants with abnormal TVS are referred to a gynecologic oncologist who decides whether standard clinical intervention for potential ovarian cancer is needed. Participants who are not referred for standard clinical intervention continue CA125 screening as above. Participants who are referred for standard clinical intervention, have at least 1 ovary remaining, and are found to have no malignancy continue CA125 screening as above. Participants who are referred for standard clinical intervention, are found to have no malignancy, and then undergo prophylactic bilateral oophorectomy proceed to CA125 screening as in group B below. Participants who are referred for standard clinical intervention and are found to have malignancy are taken off study.

Group B (no ovaries at baseline) (closed to accrual as of 10/18/04):

• Participants are assigned to 1 of 2 subgroups based on ROCA.

• Subgroup B1: Participants with normal-risk for ovarian cancer (ROCA less than 5%) continue CA 125 screening as above.

• Subgroup B2: Participants with elevated-risk for ovarian cancer (ROCA more than 5%) undergo an additional blood draw for a confirmatory CA125 level and are then referred to a gynecologic oncologist who decides whether standard clinical intervention for potential ovarian cancer is needed. Participants who are not referred for standard clinical intervention continue CA125 screening as above. Participants who are referred for standard clinical intervention and are not found to have malignancy continue CA125 screening as above. Participants who are referred for standard clinical intervention and are found to have malignancy are taken off study.

Patients are followed for clinical diagnosis for 1 additional year.

PROJECTED ACCRUAL: Approximately 2,430 participants will be accrued for this study within 12 months. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

• NCT number: NCT00039559
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2002
• Completion date: December 2014