Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039559
Status:
UNKNOWN
Last Update Posted:
2013-06-10
First Post:
2002-06-06
Brief Title:
Clinical Trial to Screen Participants Who Are at High Genetic Risk for Ovarian Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Ovarian Cancer Screening Pilot Trial in High Risk Women
Status:
UNKNOWN
Status Verified Date:
2013-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 101804
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 101804
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 2430 participants will be accrued for this study within 12 months
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 101804
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 101804
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 2430 participants will be accrued for this study within 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MGH-000084 | None | None | None |