oncoFISH Cervical Test for Detection of 3q26 Region Gain | NCT01416922

Studies
oncoFISH Cervical Test for Detection of 3q26 Region Gain

NCT01416922

Sponsor

Ikonisys, Inc.

Status

Unknown status

Last Update Posted

Aug 15, 2011Estimated

Enrollment

1,100Estimated

Phase

Not provided

Conditions

Cervical Cancer
LSIL

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

Aug 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Not provided

Completion Date

Dec 2011Estimated

First Submitted Date

Aug 12, 2011

First Submission Date that Met QC Criteria

Aug 12, 2011

First Posted Date

Aug 15, 2011Estimated

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

Aug 12, 2011

Last Update Posted Date

Aug 15, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 evaluate the use of the oncoFISH cervical test system in the management of women who have received an LSIL Pap report to determine whether the test can predict which women will progress to more serious cervical disease and which women do not have to be monitored as closely.

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

No data available

No data is available for this block.

Enrollment

1,100Estimated

Label	Type	Description	Intervention Names
LSIL		Women 21 years of age or older with an LSIL diagnosis

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women 21 years of age or greater with recent LSIL who are scheduled for colposcipal assessment.
Women with previous or current STD or HIV may be included
Women with previous LSIL history may be included.

Exclusion Criteria:

pregnant women,
women with vaginal intraepithelial lesions,
women on a chemotherapeutic agent,
women with previous or current cancer except for non-cervical squamous cell carcinoma

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients 21 years of age or greater with LSIL cytology diagnosis who are scheduled for a colposcical assessment.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael W Kilpatrick, Ph.D.	Ikonisys, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ikonisys		New Haven	Connecticut	06511	United States

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided