Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080639
Status:
WITHDRAWN
Last Update Posted:
2013-08-05
First Post:
2004-04-07
Brief Title:
CA-125 in Screening Patients at High Risk for Ovarian Cancer
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Specialized Program Of Research Excellence SPORE In Ovarian CancerCancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women
Status:
WITHDRAWN
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated for administrative reasons and becuase there were no enrollments
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Measuring levels of CA 125 in blood samples of women who have a high risk of developing ovarian cancer may help doctors detect cancer early and plan more effective treatment
PURPOSE This phase II trial is studying CA-125 levels in screening for cancer in women who are at high risk of developing ovarian cancer
PURPOSE This phase II trial is studying CA-125 levels in screening for cancer in women who are at high risk of developing ovarian cancer
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility of prospective screening for ovarian cancer in high-risk patients
Determine normal ranges and distributions of CA 125 within and between these patients with subclassification by menopausal status estrogen replacement therapy usage and prophylactic oophorectomy
Secondary
Determine estimates of the specificity and positive predictive value of a risk of cancer algorithm suitable for designing a definitive trial of screening for ovarian cancer in these patients
OUTLINE This is a multicenter pilot study
Patients undergo blood collection and CA 125 levels are measured at baseline and then every 3 months for 1-2 years Patients may be referred for an ovarian ultrasound if indicated by the CA 125 results
Patients are followed at 6 months and then annually thereafter
PROJECTED ACCRUAL A total of 2400 patients will be accrued for this study within 1 year
Primary
Determine the feasibility of prospective screening for ovarian cancer in high-risk patients
Determine normal ranges and distributions of CA 125 within and between these patients with subclassification by menopausal status estrogen replacement therapy usage and prophylactic oophorectomy
Secondary
Determine estimates of the specificity and positive predictive value of a risk of cancer algorithm suitable for designing a definitive trial of screening for ovarian cancer in these patients
OUTLINE This is a multicenter pilot study
Patients undergo blood collection and CA 125 levels are measured at baseline and then every 3 months for 1-2 years Patients may be referred for an ovarian ultrasound if indicated by the CA 125 results
Patients are followed at 6 months and then annually thereafter
PROJECTED ACCRUAL A total of 2400 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| UAB-120 | None | None | None |
| UAB-0120 | None | None | None |