Risk of Ovarian Cancer in Patients With a Pelvic Mass

NCT00315692 | Completed

• 1 other identifier: FDI-03 Pelvic Mass Study
• Study Type: observational
• Target: 566
• Locations: 1 country
• Sites: 2

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).

Conditions

Ovarian Cancer

Keywords

Ovarian Neoplasms

Outcome Measures

Primary Outcomes (1)

• Cancer vs Benign Disease

Study Arms (2)

Premenopausal women

Device: Biomarker Assay (CA125 and HE4)

Postmenopausal women

Device: Biomarker Assay (CA125 and HE4)

Interventions

Biomarker Assay (CA125 and HE4) DEVICE

Postmenopausal women; Premenopausal women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women undergoing surgery for the removal of a pelvic mass.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujirebio Diagnostics, Inc.: lead

Study Sites (2)

Fujirebio Diagnostics, Inc

Malvern, Pennsylvania, 19355, United States

Location

Richard Moore

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

• 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.

  PMID: 18851871 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma and urine

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Richard Moore, M.D.

  Womens and Infant's Hosapital of Rhode Island

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2006
• First Posted: April 19, 2006
• Study Start: December 1, 2005
• Study Completion: February 1, 2007
• Last Updated: November 8, 2011

Record last verified: 2011-11

Locations

US (2)