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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Onconix, Inc.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01371695
First Posted: June 13, 2011
Last Update Posted: June 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Onconix, Inc
  Purpose
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.

Condition
Cervical Cancer Cervical Intraepithelial Neoplasia II Cervical Intraepithelial Neoplasia III

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Phase 1 of Serum IGF II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Onconix, Inc:

Biospecimen Retention:   Samples With DNA
frozen serum

Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
university clinic
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371695


Locations
United States, Georgia
Georgia Health Sciences
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Onconix, Inc
  More Information

Responsible Party: Sharad A. Ghamande, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT01371695     History of Changes
Other Study ID Numbers: onc11-03-164
First Submitted: June 9, 2011
First Posted: June 13, 2011
Last Update Posted: June 13, 2011
Last Verified: June 2011

Keywords provided by Onconix, Inc:
IGF-II levels

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions