NCT01466049

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2011

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

2.2 years

First QC Date

November 3, 2011

Last Update Submit

August 4, 2014

Conditions

Adnexal Mass

Keywords

Ovarian CancerAdnexal MassPelvic Mass

Outcome Measures

Primary Outcomes (1)

  • Evaluate novel biomarkers for patients with an adnexal mass

    observational studies

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women with an adnexal mass, presenting to a general surgeon or obstetrician/ gynecologist at a general or specialty center within the United States, for whom a decision to proceed with surgery to remove the mass has been made.

You may qualify if:

  • 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

You may not qualify if:

  • Previous history of ovarian cancer
  • Previous history of bilateral oophorectomy
  • Currently known to be pregnant
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New Hanover Regional Medical Center

Wilmington, North Carolina, 28402, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73110, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Diana Dickson

    Fujirebio Diagnostics, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 3, 2011

First Posted

November 7, 2011

Study Start

December 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

US(2)