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NCT01466049 Clinical Trial

New Biomarkers Evaluating Ovarian Cancer

Adnexal Mass Clinical Trial

Official title:
Evaluation of New Biomarker Assays in Ovarian Cancer Patients Presenting to a Generalist With an Adnexal Mass

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01466049
Other study ID # FDI-35
Secondary ID
Status Completed
Phase N/A
First received November 3, 2011
Last updated August 4, 2014
Start date December 2011
Est. completion date March 2014

Study information
Verified date August 2014
Source Fujirebio Diagnostics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate new biomarkers for patients presenting to a physician for surgery to remove a mass in their pelvis and to continue to evaluate these types of patients using the ROMA algorithm for post-market benefits.

Recruitment information / eligibility
Status Completed
Enrollment 280
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Female, age 18 years or older

- Adnexal mass present documented by imaging

- Scheduled to undergo surgery based on a finding of adnexal mass

- Able and willing to provide Informed Consent

Exclusion Criteria:

- Previous history of ovarian cancer

- Previous history of bilateral oophorectomy

- Currently known to be pregnant

- Unable to provide informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Oklahoma Oklahoma City Oklahoma
United States New Hanover Regional Medical Center Wilmington North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Fujirebio Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate novel biomarkers for patients with an adnexal mass observational studies No
See also
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Completed NCT06366997 - Diagnosis of Epithelial Ovarian Cancer Using Ovarian Cancer Score (OCS) Test
Completed NCT00987649 - Ovarian Cancer Risk Estimation in Patients With Pelvic Mass N/A
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Terminated NCT04668521 - Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection
Recruiting NCT05842629 - Improved Diagnosis of Ovarian Cancer
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Terminated NCT04487405 - A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
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Not yet recruiting NCT05761275 - Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach N/A
Not yet recruiting NCT03442881 - The Use of International Ovarian Tumor Analysis and Assessment of Adnexal Neoplasia in Differentiating Malignant and Benign Adnexal Masses N/A
Terminated NCT03485651 - Natera Ovarian Cancer Detection Assay
Active, not recruiting NCT04051502 - ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study
Recruiting NCT05051722 - Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Completed NCT03593681 - Compare Fallopian Tube Cells Collected by Cytuity With Removed Ovarian/Tubal Tissue to Determine Presence of Malignancy
Completed NCT02520115 - Folate Receptor in Diagnosing Ovarian Cancer Using Serum Samples From Patients With Newly Diagnosed Pelvic Mass or Previously Diagnosed Ovarian Cancer Phase 1
Recruiting NCT05461872 - Retrospective Review on PAEDIATRIC and ADOLESCENT ADNEXAL MASSES
Completed NCT03297112 - Contrast-Enhanced Subharmonic Ultrasound Imaging in Improving Characterization of Adnexal Masses in Patients Undergoing Surgery Early Phase 1
Completed NCT03837327 - Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy