Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
566 participants
OBSERVATIONAL
2005-12-31
2007-02-28
Brief Summary
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Detailed Description
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The serum tumor marker CA125 has been the most widely used marker in ovarian cancer, however, it is not sufficiently sensitive or specific for the detection of early stage disease. The levels of soluble mesothelin related peptides (SMRP) and HE4 have also recently been found to be elevated in women with ovarian cancer. The results of a pilot study suggest that the use of HE4 may improve the sensitivity of CA125 and provide for stratification of patients presenting with a pelvic mass into high, intermediate and low risk groups.
HE4 and CA125 serum levels will be evaluated in this study for their ability to stratify patients presenting with a pelvic mass into risk groups with low, intermediate or high probabilities of harboring an ovarian cancer at the time of initial presentation. The algorithm using these two serum markers to stratify patients that was developed using pilot study data will be evaluated in this prospective multicenter pelvic mass study. We will also evaluate the inclusion of additional biomarkers and risk factors, such as ultrasound score, age, and menopausal status, into the algorithm to see if there is any improvement in the stratification of patients into the risk groups.
The primary objective of the study is to estimate the risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women presenting with pelvic mass. Multiple serum biomarkers (CA125 and HE4) will be evaluated to estimate the risk that the patient is harboring an ovarian cancer at the time of presentation.
The secondary objective of the study is to develop a multivariate predictive algorithm combining CA125 and HE4 with radiological imaging results, and patient risk factors (such as age, menopausal status and ethnicity) to estimate the risk of ovarian cancer, including low malignant potential (LMP) / borderline tumors, at the time of surgery in patients presenting with a pelvic mass.
The exploratory endpoints will include the evaluation of serum, plasma and/or urine levels of CA125, HE4 and other additional novel biomarkers such as SMRP, alone and in combination with radiological imaging results and subject risk factors to determine their ability to estimate the risk of cancer at the time of surgery in patients presenting with a pelvic mass.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Premenopausal women
Biomarker Assay (CA125 and HE4)
Postmenopausal women
Biomarker Assay (CA125 and HE4)
Interventions
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Biomarker Assay (CA125 and HE4)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Subjects receiving cytotoxic chemotherapies, such as cyclophosphamide or methotrexate
* Subjects with previous bilateral oophorectomy
* Any subject known to be pregnant
18 Years
FEMALE
No
Sponsors
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Fujirebio Diagnostics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Richard Moore, M.D.
Role: PRINCIPAL_INVESTIGATOR
Womens and Infant's Hosapital of Rhode Island
Locations
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Fujirebio Diagnostics, Inc
Malvern, Pennsylvania, United States
Richard Moore
Providence, Rhode Island, United States
Countries
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References
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Moore RG, McMeekin DS, Brown AK, DiSilvestro P, Miller MC, Allard WJ, Gajewski W, Kurman R, Bast RC Jr, Skates SJ. A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol. 2009 Jan;112(1):40-6. doi: 10.1016/j.ygyno.2008.08.031. Epub 2008 Oct 12.
Other Identifiers
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FDI-03 Pelvic Mass Study
Identifier Type: -
Identifier Source: org_study_id