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:
Centre Oscar Lambret
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
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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
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 May 23, 2013