Risk of Ovarian Cancer in Patients With a Pelvic Mass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fujirebio Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT00315692
First received: April 18, 2006
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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).


Condition Intervention
Ovarian Cancer
Device: Biomarker Assay (CA125 and HE4)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Multiple Biomarker Assay to Estimate the Risk of Ovarian Cancer in Patients Presenting With a Pelvic Mass.

Resource links provided by NLM:


Further study details as provided by Fujirebio Diagnostics, Inc.:

Primary Outcome Measures:
  • Cancer vs Benign Disease [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum, plasma and urine


Enrollment: 566
Study Start Date: December 2005
Study Completion Date: February 2007
Groups/Cohorts Assigned Interventions
Premenopausal women Device: Biomarker Assay (CA125 and HE4)
Postmenopausal women Device: Biomarker Assay (CA125 and HE4)

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women undergoing surgery for the removal of a pelvic mass.

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315692

Locations
United States, Pennsylvania
Fujirebio Diagnostics, Inc
Malvern, Pennsylvania, United States, 19355
United States, Rhode Island
Richard Moore
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Fujirebio Diagnostics, Inc.
Investigators
Principal Investigator: Richard Moore, M.D. Womens and Infant's Hosapital of Rhode Island
  More Information

No publications provided by Fujirebio Diagnostics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fujirebio Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT00315692     History of Changes
Other Study ID Numbers: FDI-03 Pelvic Mass Study
Study First Received: April 18, 2006
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Fujirebio Diagnostics, Inc.:
Ovarian Neoplasms

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 22, 2014