Ovarian Cancer Risk Estimation in Patients With Pelvic Mass | NCT00987649

Studies
Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

NCT00987649

Sponsor

Fujirebio Diagnostics, Inc.

Status

Completed

Last Update Posted

Feb 9, 2011Estimated

Enrollment

512Actual

Phase

Not provided

Conditions

Adnexal Mass
Ovarian Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Aug 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Sep 30, 2009

First Submission Date that Met QC Criteria

Sep 30, 2009

First Posted Date

Oct 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2011

Last Update Posted Date

Feb 9, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Fujirebio Diagnostics, Inc.INDUSTRY

Collaborators

Name	Class
Advanced Clinical Research Services, LLC	OTHER
ReSearch Pharmaceutical Services, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether the Risk of Ovarian Cancer Algorithm (ROMA) is effective in the determination of a woman's risk of cancer when she is scheduled to have surgery to remove a pelvic mass.

After Informed Consent is obtained, an Initial Cancer Risk Assessment will be made. A blood sample will be collected within 30 days of the surgical procedure. Results of the surgical procedure will be collected and analyzed against the CA125 and HE4 results used in the calculation of the ROMA.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

512Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1. A statistically higher number of cancer patients are correctly assigned by the combination of Initial Cancer Risk assessment and positive ROMA test result than by Initial Cancer Risk assessment alone		Blood draw within 30 days of surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female, age ≥ 18 years
Adnexal mass present documented by imaging
Scheduled to undergo surgery based on a finding of adnexal mass (defined as a simple, complex or a solid ovarian cyst/or any mass in pelvis)
Able to understand 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

It is anticipated that approximately 10 general or specialty centers geographically dispersed throughout the United States will be utilized.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Moore, MD, FACOG, FACS	Women & Infants Hospital Rhode Island	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scripps Clinic Carmel Valley		San Diego	California	92130	United States
Women's Clinic of Northern Colorado

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25449569	Derived	Moore RG, Hawkins DM, Miller MC, Landrum LM, Gajewski W, Ball JJ, Allard WJ, Skates SJ. Combining clinical assessment and the Risk of Ovarian Malignancy Algorithm for the prediction of ovarian cancer. Gynecol Oncol. 2014 Dec;135(3):547-51. doi: 10.1016/j.ygyno.2014.10.017. Epub 2014 Oct 23.

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases