| TITRE |
Étude prospective non interventionnelle chez des patients atteints d’un cancer avec fusion du gène TRK localement avancé ou métastatique traités par le larotrectinib |
| PROTOCOLE ID |
20324 |
| CLINICAL TRIAL.gov ID |
NCT04142437 |
| TYPE(S) DE CANCER |
Tumeurs solides |
| PHASE |
Autres |
| TYPE D'ÉTUDE |
Autre |
| INSTITUTION |
CHU DE QUEBEC – UNIVERSITE LAVAL
11 Côte du Palais
(418) 525-4444
|
| VILLE |
Québec
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Valérie Larouche
|
| COORDONATEUR(RICE) |
Panagiota Giannakouros
panagiota.giannak@crchudequebec.ulaval.ca
418-525-4444 poste 40121
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Adult and pediatric (from birth to 18 year old) patients
- Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.
- Life expectancy of at least 3 months based on clinical judgement
- Decision to treat with larotrectinib made by the treating physician prior to study enrollment
- Signed informed consent form
- For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required
|
| CRITÈRES D'EXCLUSION |
(EN)
- Any contraindications as listed in the local approved product information
- Pregnancy
- Participation in an investigational program with interventions outside of routine clinical practice
- Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
- Patients with NTRK gene amplification or NTRK point mutation
|
