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
  Purpose

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


Condition Intervention
Cancer
Solid Tumor
Biological: CPK dosage
Other: Clinical exam

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 154
Study Start Date: November 2010
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248429

Locations
France
Centre Paul Papin
Angers, France, 49000
Hôpital Jean Minjoz
Besancon, France, 25030
Institut Bergonié
Bordeaux, France, 33076
CHU Bordeaux
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
Centre Léon Bérard
Lyon, France, 69008
Hôpital Edouard Herriot
Lyon, France, 69003
Institut Paoli Calmettes
Marseille, France, 13273
Centre Val d'Aurelle
Montpellier, France, 34298
Centre Antoine Lacassagne
Nice, France, 06189
Institut Curie
Paris, France, 75248
Hôpital Saint-Louis - APHP
Paris, France, 75010
Hôpital Tenon - APHP
Paris, France, 75020
Hôpital Cochin - APHP
Paris, France, 75014
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
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01248429     History of Changes
Other Study ID Numbers: TKI-CPK 1003
Study First Received: November 24, 2010
Last Updated: June 6, 2012
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 23, 2014