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

• Conditions: Cervical Intraepithelial Neoplasia III; Cervical Cancer; Cervical Intraepithelial Neoplasia II

• Registration Number: NCT01371695
• Lead Sponsor: Onconix, Inc

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 available

Study Timeline

• Study Start: 2011-05
• Status Verified: 2011-06
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-10
• Last Update Submitted: 2011-06-10
• Study First Posted: 2011-06-13
• Last Update Posted: 2011-06-13
• Primary Completion: 2011-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Georgia Health Sciences; 🇺🇸 Augusta, Georgia, United States