Risk of Ovarian Cancer in Patients With a Pelvic Mass
|ClinicalTrials.gov Identifier: NCT00315692|
Recruitment Status : Completed
First Posted : April 19, 2006
Last Update Posted : November 8, 2011
|First Submitted Date||April 18, 2006|
|First Posted Date||April 19, 2006|
|Last Update Posted Date||November 8, 2011|
|Study Start Date||December 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Cancer vs Benign Disease|
|Original Primary Outcome Measures||Not Provided|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Risk of Ovarian Cancer in Patients With a Pelvic Mass|
|Official Title||Evaluation of a Multiple Biomarker Assay to Estimate the Risk of Ovarian Cancer in Patients Presenting With a Pelvic Mass.|
|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 a solid ovarian cyst / pelvic mass).|
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 oncologist with a pelvic mass (defined as a simple, complex or a solid ovarian cyst / pelvic mass) who are scheduled to undergo surgery.
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.
|Study Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples Without DNA
Serum, plasma and urine
|Sampling Method||Probability Sample|
|Study Population||Women undergoing surgery for the removal of a pelvic mass.|
|Intervention||Device: Biomarker Assay (CA125 and HE4)|
|Publications *||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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Actual Study Completion Date||February 2007|
|Primary Completion Date||Not Provided|
|Ages||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||FDI-03 Pelvic Mass Study|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Fujirebio Diagnostics, Inc.|
|Study Sponsor||Fujirebio Diagnostics, Inc.|
|PRS Account||Fujirebio Diagnostics, Inc.|
|Verification Date||November 2011|