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

June 10, 2011 updated by: Onconix, Inc

Phase 1 of Serum IGF II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

university clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onconix, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

September 1, 2011

Study Completion (ANTICIPATED)

September 1, 2013

Study Registration Dates

First Submitted

June 9, 2011

First Submitted That Met QC Criteria

June 10, 2011

First Posted (ESTIMATE)

June 13, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2011

Last Update Submitted That Met QC Criteria

June 10, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • onc11-03-164

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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