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

This study is enrolling participants by invitation only.
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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Complete list of historical versions of study NCT01371695 on ClinicalTrials.gov Archive Site
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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
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Retention:   Samples With DNA
Description:

frozen serum

Probability Sample

university clinic

  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia II
  • Cervical Intraepithelial Neoplasia III
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01371695
onc11-03-164
No
Sharad A. Ghamande, Georgia Health Sciences University
Onconix, Inc
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Not Provided
Onconix, Inc
June 2011

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