Prevalence of Creatinine Phosphokinase Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases

Cancer Clinical Trial

— TKI-CPK-1003  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248429
• Other study ID #: TKI-CPK 1003
• Status: Completed
• Phase: N/A
• First received: November 24, 2010
• Last updated: June 6, 2012
• Start date: November 2010
• Est. completion date: February 2011

Study information

• Verified date: June 2012
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Hôpital Jean Minjoz	Besancon
France	CHU Bordeaux	Bordeaux
France	Institut Bergonié	Bordeaux
France	Centre François Baclesse	Caen
France	Centre Jean Perrin	Clermont Ferrand
France	Hôpital Henri Mondor - APHP	Creteil
France	Centre Oscar Lambret	Lille
France	CHU Limoges	Limoges
France	Centre Léon Bérard	Lyon
France	Hôpital Edouard Herriot	Lyon
France	Institut Paoli Calmettes	Marseille
France	Centre Val d'Aurelle	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Hôpital Cochin - APHP	Paris
France	Hôpital Saint-Louis - APHP	Paris
France	Hôpital Tenon - APHP	Paris
France	Institut Curie	Paris
France	CHU Robert Debré	Reims
France	Institut Jean Godinot	Reims
France	Centre Eugène Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Centre René Huguenin	Saint Cloud
France	Institut de Cancérologie de la Loire	Saint Priest en Jarez
France	Institut Claudius Régaud	Toulouse
France	Centre Alexis Vautrin	Vandoeuvre Les Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the prevalence of the CPK increase	Dosage of CPK during standard blood sampling. The increase of CPK is defined when CPK value > USL	Within 3 days after a clinical exam	No
Secondary	Correlation myalgia/CPK increase	To determine the correlation between myalgia and CPK blood, taking into account the risk factors leading to CPK increase	During the clinical exam	No