- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01248429
Prevalence of Creatinine Phosphokinase Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases (TKI-CPK)
March 12, 2026 updated by: Centre Oscar Lambret
National Study of Prevalence of Creatinine Phosphokinase (CPK) Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases (TKI)
This study describes the elevation of CPK in patient treated for solid tumors by TKI
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
154
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Angers, France, 49000
- Centre Paul Papin
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Besançon, France, 25030
- Hopital Jean Minjoz
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Bordeaux, France, 33076
- Institut Bergonie
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Bordeaux, France, 33076
- CHU Bordeaux
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Caen, France, 14076
- Centre Francois Baclesse
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Clermont-Ferrand, France, 63011
- Centre Jean Perrin
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Créteil, France, 94010
- Hôpital Henri Mondor - APHP
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Lille, France, 59020
- Centre Oscar Lambret
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Limoges, France, 87042
- CHU Limoges
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Lyon, France, 69008
- Centre Leon Berard
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Lyon, France, 69003
- Hôpital Edouard Herriot
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Marseille, France, 13273
- Institut Paoli Calmettes
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Montpellier, France, 34298
- Centre Val d'Aurelle
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Nice, France, 06189
- Centre Antoine Lacassagne
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Paris, France, 75248
- Institut Curie
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Paris, France, 75014
- Hopital Cochin - APHP
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Paris, France, 75010
- Hopital Saint-Louis - APHP
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Paris, France, 75020
- Hôpital Tenon - APHP
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Reims, France, 51056
- Institut Jean Godinot
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Reims, France, 51092
- CHU Robert Debré
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Rennes, France, 35042
- Centre Eugène Marquis
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Rouen, France, 76000
- Centre Henri Becquerel
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Saint-Cloud, France, 92211
- Centre René Huguenin
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Saint-Priest-en-Jarez, France, 42271
- Institut de cancérologie de la Loire
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Toulouse, France, 31052
- Institut Claudius Regaud
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Vandœuvre-lès-Nancy, France, 54511
- Centre Alexis Vautrin
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Villejuif, France, 94805
- Institut Gustave Roussy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients treated for a solid tumor by thyrosin kinase inhibitors
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patient treated by TKI
Any patient with solid tumor and treated by Thyrosine Kinase Inhibitor for at least 1 week
|
CPK dosage during a blood sample realized at least one week after the begining of the treatment
Examination of the patient for myalgia, cramps, medical history and concomitant medication
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Within 3 days after a clinical exam
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
During the clinical exam
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Antoine ADENIS, MD, PhD, Centre Oscar Lambret
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
January 15, 2013
Study Registration Dates
First Submitted
November 24, 2010
First Submitted That Met QC Criteria
November 24, 2010
First Posted (Estimated)
November 25, 2010
Study Record Updates
Last Update Posted (Actual)
March 16, 2026
Last Update Submitted That Met QC Criteria
March 12, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TKI-CPK-1003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.