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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:
Information provided by:
Onconix, Inc
ClinicalTrials.gov Identifier:
NCT01371695
First received: June 9, 2011
Last updated: June 10, 2011
Last verified: June 2011
June 9, 2011
June 10, 2011
May 2011
September 2011   (Final data collection date for primary outcome measure)
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No Changes Posted
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Serum IGF-II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer
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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
frozen serum
Probability Sample
university clinic
  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia II
  • Cervical Intraepithelial Neoplasia III
Not Provided
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
September 2013
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01371695
onc11-03-164
No
Not Provided
Not Provided
Sharad A. Ghamande, Georgia Health Sciences University
Onconix, Inc
Not Provided
Not Provided
Onconix, Inc
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP