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

NCT ID: NCT01371695

Last Updated: 2011-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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Cervical Cancer Cervical Intraepithelial Neoplasia II Cervical Intraepithelial Neoplasia III

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Onconix, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Georgia Health Sciences University

Locations

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Georgia Health Sciences

Augusta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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onc11-03-164

Identifier Type: -

Identifier Source: org_study_id

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