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

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ClinicalTrials.gov Identifier: NCT01248429
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : June 7, 2012
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret

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

Condition or disease Intervention/treatment
Cancer Solid Tumor Biological: CPK dosage Other: Clinical exam

Study Type : Observational
Actual Enrollment : 154 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Study of Prevalence of Creatinine Phosphokinase (CPK) Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases (TKI)
Study Start Date : November 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Creatinine
Drug Information available for: Tyrosine
U.S. FDA Resources

Group/Cohort Intervention/treatment
Patient treated by TKI
Any patient with solid tumor and treated by Thyrosine Kinase Inhibitor for at least 1 week
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



Primary Outcome Measures :
  1. To evaluate the prevalence of the CPK increase [ Time Frame: Within 3 days after a clinical exam ]
    Dosage of CPK during standard blood sampling. The increase of CPK is defined when CPK value > USL


Secondary Outcome Measures :
  1. Correlation myalgia/CPK increase [ Time Frame: During the clinical exam ]
    To determine the correlation between myalgia and CPK blood, taking into account the risk factors leading to CPK increase



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated for a solid tumor by thyrosin kinase inhibitors
Criteria

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

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): NCT01248429


Locations
France
Centre Paul Papin
Angers, France, 49000
Hôpital Jean Minjoz
Besancon, France, 25030
CHU Bordeaux
Bordeaux, France, 33076
Institut Bergonié
Bordeaux, France, 33076
Centre François Baclesse
Caen, France, 14076
Centre Jean Perrin
Clermont Ferrand, France, 63011
Hôpital Henri Mondor - APHP
Creteil, France, 94010
Centre Oscar Lambret
Lille, France, 59020
CHU Limoges
Limoges, France, 87042
Hôpital Edouard Herriot
Lyon, France, 69003
Centre Léon Bérard
Lyon, France, 69008
Institut Paoli Calmettes
Marseille, France, 13273
Centre Val d'Aurelle
Montpellier, France, 34298
Centre Antoine Lacassagne
Nice, France, 06189
Hôpital Saint-Louis - APHP
Paris, France, 75010
Hôpital Cochin - APHP
Paris, France, 75014
Hôpital Tenon - APHP
Paris, France, 75020
Institut Curie
Paris, France, 75248
Institut Jean Godinot
Reims, France, 51056
CHU Robert Debré
Reims, France, 51092
Centre Eugène Marquis
Rennes, France, 35042
Centre Henri Becquerel
Rouen, France, 76000
Centre René Huguenin
Saint Cloud, France, 92211
Institut de Cancérologie de la Loire
Saint Priest en Jarez, France, 42271
Institut Claudius Régaud
Toulouse, France, 31052
Centre Alexis Vautrin
Vandoeuvre Les Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Antoine ADENIS, MD, PhD Centre Oscar Lambret

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01248429     History of Changes
Other Study ID Numbers: TKI-CPK 1003
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012

Keywords provided by Centre Oscar Lambret:
thyrosine kinase inhibitor
phosphokinase creatinin
myalgia