Status:
COMPLETED
Risk of Ovarian Cancer in Patients With a Pelvic Mass
Lead Sponsor:
Fujirebio Diagnostics, Inc.
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
The purpose of this clinical trial is to evaluate the ability of multiple serum biomarkers to estimate the risk of ovarian cancer in women presenting with pelvic mass (defined as a simple, complex or ...
Detailed Description
The Pelvic Mass study is a prospective, multi-center, double blind, statistically powered clinical trial that will enroll female subjects ≥18 years of age presenting to a gynecologist or gynecological...
Eligibility Criteria
Inclusion
- Females selected to undergo laparotomy or laparoscopy based on a finding of pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass);
- Pre- and post-menopausal women greater than or equal to 18 years of age;
- Pelvic mass must be demonstrated by ultrasound
- Able to understand and sign Informed Consent
Exclusion
- Treatment for any malignancy (with the exception of non-melanoma skin cancer) within the last five years
- Subjects receiving cytotoxic chemotherapies, such as cyclophosphamide or methotrexate
- Subjects with previous bilateral oophorectomy
- Any subject known to be pregnant
Key Trial Info
Start Date :
December 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
566 Patients enrolled
Trial Details
Trial ID
NCT00315692
Start Date
December 1 2005
End Date
February 1 2007
Last Update
November 8 2011
Active Locations (2)
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1
Fujirebio Diagnostics, Inc
Malvern, Pennsylvania, United States, 19355
2
Richard Moore
Providence, Rhode Island, United States, 02905