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

Completed

• Conditions: Cancer; Solid Tumor
• Interventions: Biological: CPK dosage; Other: Clinical exam

• Registration Number: NCT01248429
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Primary Completion: 2010-12
• Study Completion: 2011-02
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient treated by TKI	CPK dosage	Any patient with solid tumor and treated by Thyrosine Kinase Inhibitor for at least 1 week
Patient treated by TKI	Clinical exam	Any patient with solid tumor and treated by Thyrosine Kinase Inhibitor for at least 1 week

Primary Outcome Measures

Name	Time	Method
To evaluate the prevalence of the CPK increase	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

Name	Time	Method
Correlation myalgia/CPK increase	During the clinical exam	To determine the correlation between myalgia and CPK blood, taking into account the risk factors leading to CPK increase

Trial Locations

Locations (27)

Hôpital Jean Minjoz; 🇫🇷 Besancon, France

Centre Paul Papin; 🇫🇷 Angers, France

Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

Institut Bergonié; 🇫🇷 Bordeaux, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Jean Perrin; 🇫🇷 Clermont Ferrand, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Hôpital Henri Mondor - APHP; 🇫🇷 Creteil, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

CHU Limoges; 🇫🇷 Limoges, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Hôpital Saint-Louis - APHP; 🇫🇷 Paris, France

Hôpital Cochin - APHP; 🇫🇷 Paris, France

Hôpital Tenon - APHP; 🇫🇷 Paris, France

Institut Curie; 🇫🇷 Paris, France

CHU Robert Debré; 🇫🇷 Reims, France

Institut Jean Godinot; 🇫🇷 Reims, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Centre René Huguenin; 🇫🇷 Saint Cloud, France

Institut Claudius Régaud; 🇫🇷 Toulouse, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Institut de Cancérologie de la Loire; 🇫🇷 Saint Priest en Jarez, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre Les Nancy, France