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

Sponsor
Centre Oscar Lambret (Other)
Overall Status
Completed
CT.gov ID
NCT01248429
Collaborator
(none)
154
27
3
5.7
1.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: CPK dosage
  • Other: Clinical exam

Study Design

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 :
Nov 1, 2010
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Feb 1, 2011

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Paul Papin Angers France 49000
2 Hôpital Jean Minjoz Besancon France 25030
3 CHU Bordeaux Bordeaux France 33076
4 Institut Bergonié Bordeaux France 33076
5 Centre François Baclesse Caen France 14076
6 Centre Jean Perrin Clermont Ferrand France 63011
7 Hôpital Henri Mondor - APHP Creteil France 94010
8 Centre Oscar Lambret Lille France 59020
9 CHU Limoges Limoges France 87042
10 Hôpital Edouard Herriot Lyon France 69003
11 Centre Léon Bérard Lyon France 69008
12 Institut Paoli Calmettes Marseille France 13273
13 Centre Val d'Aurelle Montpellier France 34298
14 Centre Antoine Lacassagne Nice France 06189
15 Hôpital Saint-Louis - APHP Paris France 75010
16 Hôpital Cochin - APHP Paris France 75014
17 Hôpital Tenon - APHP Paris France 75020
18 Institut Curie Paris France 75248
19 Institut Jean Godinot Reims France 51056
20 CHU Robert Debré Reims France 51092
21 Centre Eugène Marquis Rennes France 35042
22 Centre Henri Becquerel Rouen France 76000
23 Centre René Huguenin Saint Cloud France 92211
24 Institut de Cancérologie de la Loire Saint Priest en Jarez France 42271
25 Institut Claudius Régaud Toulouse France 31052
26 Centre Alexis Vautrin Vandoeuvre Les Nancy France 54511
27 Institut Gustave Roussy Villejuif France 94805

Sponsors and Collaborators

  • Centre Oscar Lambret

Investigators

  • Principal Investigator: Antoine ADENIS, MD, PhD, Centre Oscar Lambret

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01248429
Other Study ID Numbers:
  • TKI-CPK 1003
First Posted:
Nov 25, 2010
Last Update Posted:
Jun 7, 2012
Last Verified:
Jun 1, 2012
Keywords provided by Centre Oscar Lambret
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2012