NCT01248429

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Typical duration for all trials

Geographic Reach
1 country

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2013

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

November 24, 2010

Last Update Submit

March 12, 2026

Conditions

Keywords

thyrosine kinase inhibitorphosphokinase creatininmyalgia

Outcome Measures

Primary Outcomes (1)

  • To evaluate the prevalence of the CPK increase

    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 Outcomes (1)

  • Correlation myalgia/CPK increase

    During the clinical exam

Study Arms (1)

Patient treated by TKI

Any patient with solid tumor and treated by Thyrosine Kinase Inhibitor for at least 1 week

Biological: CPK dosageOther: Clinical exam

Interventions

Examination of the patient for myalgia, cramps, medical history and concomitant medication

Patient treated by TKI
CPK dosageBIOLOGICAL

CPK dosage during a blood sample realized at least one week after the begining of the treatment

Patient treated by TKI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated for a solid tumor by thyrosin kinase inhibitors

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Centre Paul Papin

Angers, 49000, France

Location

Hôpital Jean Minjoz

Besançon, 25030, France

Location

CHU Bordeaux

Bordeaux, 33076, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Hôpital Henri Mondor - APHP

Créteil, 94010, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

CHU Limoges

Limoges, 87042, France

Location

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hôpital Saint-Louis - APHP

Paris, 75010, France

Location

Hôpital Cochin - APHP

Paris, 75014, France

Location

Hôpital Tenon - APHP

Paris, 75020, France

Location

Institut Curie

Paris, 75248, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

CHU Robert Debré

Reims, 51092, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Centre Henri Becquerel

Rouen, 76000, France

Location

Centre René Huguenin

Saint-Cloud, 92211, France

Location

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, 42271, France

Location

Institut Claudius Régaud

Toulouse, 31052, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

NeoplasmsMyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Antoine ADENIS, MD, PhD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2010

First Posted

November 25, 2010

Study Start

November 1, 2010

Primary Completion

December 1, 2010

Study Completion

January 15, 2013

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations