Serum IGF-II and Cancer: Can IGF II Levels be Used to Mon... | NCT01371695

Studies
Serum IGF-II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer

NCT01371695

Sponsor

Onconix, Inc

Status

Unknown status

Last Update Posted

Jun 13, 2011Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Cervical Cancer
Cervical Intraepithelial Neoplasia II
Cervical Intraepithelial Neoplasia III

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

Jun 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

May 2011

Primary Completion Date

Sep 2011Estimated

Completion Date

Sep 2013Estimated

First Submitted Date

Jun 9, 2011

First Submission Date that Met QC Criteria

Jun 10, 2011

First Posted Date

Jun 13, 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

Jun 10, 2011

Last Update Posted Date

Jun 13, 2011Estimated

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 Insulin-like Growth Factor II is elevated sufficiently to detect Cervical Intraepithelial Neoplasia II (CIN II), Cervical Intraepithelial Neoplasia III (CIN III), and cervical cancer.

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

60Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 - 75 years
Female
Normal medical history
Medical history of a single type of cancer confirmed by biopsy or equivalent criteria
Squamous cell carcinoma of organs other than cervix
Adenocarcinoma
Medical history of inflammatory disease
May be pregnant
Pap smear positive for Cervical Intraepithelial Neoplasia II or III
Squamous cell cervical cancer confirmed by biopsy
Informed consent
Willingness to submit a blood sample by venipuncture
Willingness to submit a second blood sample if necessary

Exclusion Criteria:

Age < 18 or > 75 years
Medical history of cancer other than cervical cancer, Non-islet-cell tumor hypoglycemia, Growth hormone deficiency, Acromegaly, Hepatoma, inflammatory disease in addition to confirmed CIN and cervical cancer

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

university clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Georgia Health Sciences		Augusta	Georgia	30912	United States

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D002578	Uterine Cervical Dysplasia

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