Prevalence of Creatinine Phosphokinase Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases (TKI-CPK-1003)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01248429
First received: November 24, 2010
Last updated: June 6, 2012
Last verified: June 2012

November 24, 2010
June 6, 2012
November 2010
December 2010   (final data collection date for primary outcome measure)
To evaluate the prevalence of the CPK increase [ Time Frame: Within 3 days after a clinical exam ] [ Designated as safety issue: No ]
Dosage of CPK during standard blood sampling. The increase of CPK is defined when CPK value > USL
Same as current
Complete list of historical versions of study NCT01248429 on ClinicalTrials.gov Archive Site
Correlation myalgia/CPK increase [ Time Frame: During the clinical exam ] [ Designated as safety issue: No ]
To determine the correlation between myalgia and CPK blood, taking into account the risk factors leading to CPK increase
Same as current
Not Provided
Not Provided
 
Prevalence of Creatinine Phosphokinase Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases
National Study of Prevalence of Creatinine Phosphokinase (CPK) Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases (TKI)

This study describes the elevation of CPK in patient treated for solid tumors by TKI

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients treated for a solid tumor by thyrosin kinase inhibitors

  • Cancer
  • Solid Tumor
  • Biological: CPK dosage
    CPK dosage during a blood sample realized at least one week after the begining of the treatment
  • Other: Clinical exam
    Examination of the patient for myalgia, cramps, medical history and concomitant medication
Patient treated by TKI
Any patient with solid tumor and treated by Thyrosine Kinase Inhibitor for at least 1 week
Interventions:
  • Biological: CPK dosage
  • Other: Clinical exam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
February 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with solid tumor treated by inhibitor of tyrosin kinase for at least 1 week
  • Patient examined AND with a routine blood test planned
  • Patient informed of procedure for the study who was not opposed to it

Exclusion Criteria:

  • Patient treated for malignant hemopathy
  • Patient no treated by inhibitor of thyrosine kinase or for less than 1 week
  • Patients with no routine blood laboratory tests planned
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01248429
TKI-CPK 1003
No
Centre Oscar Lambret
Centre Oscar Lambret
Not Provided
Principal Investigator: Antoine ADENIS, MD, PhD Centre Oscar Lambret
Centre Oscar Lambret
June 2012

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