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Comparison of In-House Methods and Cobas BRAF V600 Mutation Assay in Melanoma Tumor Samples

25 février 2016 mis à jour par: Hoffmann-La Roche

Evaluation of Concordance Between the Methods Used in INCa Platforms and the Cobas® 4800 BRAF V600 Mutation Test for Detection of BRAF V600 Mutations in Melanoma in Real Life Setting

This non-interventional study will compare the Cobas BRAF V600 mutation assay with in-house methods used in molecular laboratories for the assessment of the BRAF mutation status in melanoma tumor samples. No patients will be enrolled in this study. Data will be collected for approximately 6 months.

Aperçu de l'étude

Statut

Complété

Les conditions

Mélanome malin

Type d'étude

Observationnel

Inscription (Réel)

420

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

France
- - Boulogne Billancourt, France, 92104
  - Colmar, France, 68024
  - Lille, France, 59037
  - Lyon, France, 69437
  - Marseille, France, 13015
  - Montpellier, France, 34295
  - Nantes, France, 44093
  - Paris, France, 75010
  - Pessac, France, 33604
  - Rouen, France, 76031
  - Vandoeuvre Les Nancy, France, 54511
  - Villejuif, France, 94505

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Enfant
Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

No patients are enrolled in this study. Use of melanoma tumor samples.

La description

Inclusion Criteria:

No patients are enrolled. Use of tumor samples only.

Histologically proven melanoma tumor sample
Any type of tumor sample: biopsy or surgical specimen of primary tumor or metastasis
Tumor samples must be fixed and paraffin-embedded.

Exclusion Criteria:

No patients are enrolled. Use of tumor samples only.

Fixative unknown

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
INCa molecular genetics laboratory "in-house" methods BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using "in-house" methods
Cobas 4800 Mutation Test BRAF V600 mutations were analysed using Cobas 4800 mutation test

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories Délai: Up to 6 months	BRAF V600 mutation status was determined by INCa molecular laboratories "in-house" methods and Cobas 4800 BRAF V600 mutation test. Samples were analysed as V600 mutation, No V600 mutation and Non evaluable. Additionally, the type of V600 mutation (E, K, R, D, E2, other V600 mutation, not specified) was also evaluated only by INCa molecular laboratory "in-house" method.	Up to 6 months

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Tumor Sample Characteristics-Type of Tumor Sample Délai: Up to 6 months	The type of tumor sample used for evaluation of BRAF V600 mutation whether it was a biopsy or surgical specimen were reported	Up to 6 months
Tumor Sample Characteristics - Source of Tumor Sample Délai: Up to 6 months	The source of tumor sample for BRAF V600 mutation detection whether taken from internal or external pathology laboratory were reported	Up to 6 months
Type of Pathology Laboratory Performing the Fixation or Embedding-Pre-analytical Method Délai: Up to 6 months	The external or internal pathology laboratories involved in the process of fixation or embedding of the tumor sample was evaluated.	Up to 6 months
Time From Sampling to Fixation- Pre-analytical Method Délai: Up to 6 months	Time taken from the sampling to the fixation of the tumor sample was reported in range of 0-2 hours, 2-6 hours, >6 hours and unknown. Number of samples falling in each of the class were reported.	Up to 6 months
Type of Fixative Used- Pre-analytical Method Délai: Up to 6 months	The different types of fixative Excell, formol, alcohol formol acetic acid and other, used to fix the tumor samples were reported.	Up to 6 months
Fixation Duration by Pre-analytical Method Délai: Up to 6 months	Fixation duration is defined as the amount of time required in hours for the fixation of a samples. The fixation duration was categorized as <6 hours, 6-24 hours and >24 hours and unknown. Number of samples falling in each category were reported	Up to 6 months
Slice Thickness by Pre-analytical Method Délai: Up to 6 months	Slice thickness of all the tumour samples was measured. The slice thickness was measured in micrometer.	Up to 6 months
Dewaxing by Pre-analytical Method Délai: Up to 6 Months	Dewaxing is a method to recover the DNA from samples. Dewaxing information was collected as "Yes, No or Missing"	Up to 6 Months
Necrosis Percentage Determination by Pre-analytical Method Délai: Up to 6 months	The percentage of necrosis defined as the death of one or more cells in the analysed zone was reported.	Up to 6 months
Percentage of Tumor Cells by Pre-analytical Method Délai: Up to 6 months	The percentage of tumor cells in the given tumor sample were reported.	Up to 6 months
Tumor Samples With Presence of Melanin by Pre-analytical Method Délai: Up to 6 months	The tumor samples with presence of melanin were categorized as Important, Few, Medium and Absent.	Up to 6 months
DNA Extraction - Extraction Method by Pre-analytical Method Délai: Up to 6 months	This method assessed DNA from the tumor samples was extracted by Automated method or Manual method.	Up to 6 months
Median DNA Elution Volume by Pre-analytical Method Délai: Up to 6 months	Median DNA elution volume microliters [mcl] was reported.	Up to 6 months
Mean DNA Concentration by Pre-analytical Method Délai: Up to 6 months	The DNA concentration in the tissue elute was measured in nanogram per microliter (ng/mcL).	Up to 6 months
Amount of DNA by Pre-analytical Method Délai: Up to 6 months	The total DNA concentration extracted from the tissue was measured in nanogram (ng).	Up to 6 months
Size of Amplicons Used by "In-house" Analytical Method Délai: Up to 6 months	The method described the size of amplicon used. It was measured in base pairs (bp).	Up to 6 months
Method of Mutation Detection by "In-house" Analytical Method Délai: Up to 6 months	Allele-specific PCR, High Resolution Melting (HRM) + Sanger sequencing, Pyrosequencing, Sanger sequencing, Real time PCR, SNaPshot were used for BRAF V600 mutation detection.	Up to 6 months
Number of Samples Punched in In-house Analytical Method Délai: Up to 6 months	Total number of samples for whom punch was used in 'in-house analytical' method are reported.	Up to 6 months
Mean Number of Slices Per Sample Used for "In-house"- Analytical Method Délai: Up to 6 months	The mean of number of slices per sample when no punch was used are reported.	Up to 6 months
Median Time Between Receipt of Samples and Determination of Result by "In-house" Analytical Method Délai: Up to 6 months	This In-house analytical method measured the time between receipt of samples to the result determination. It measured the time in days.	Up to 6 months
Technician Work Time Between DNA Extraction and Result by "In-house" Analytical Method Délai: Up to 6 months	The working time required by the technician from the time of DNA extraction to the time to obtain the results was measured in hours.	Up to 6 months
Mean DNA Concentration as Measured by COBAS 4800 BRAF V600 Mutation Test-Analytical Method Délai: Up to 6 months	The DNA concentration as assessed by COBAS 4800 BRAF V600 Mutation assay was reported. The unit used to measure the DNA concentration was nanogram/microlitre (ng/mcl)	Up to 6 months
Punch Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method Délai: Up to 6 months	The punch done during Cobas 4800 BRAF V600 Mutation Test on the sample was described as Yes or No.	Up to 6 months
Number of Slices Used When No Punch Was Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method Délai: Up to 6 months	This describes the Cobas 4800 BRAF V600 Mutation Test, for the mean of number of slices when No punch method, was used. Of the 420 samples, punch was Yes, for 45 samples and punch was No, for 375 samples.	Up to 6 months
Median Time Between Receipt of Sample and Determination of Result by Cobas 4800 BRAF V600 Mutation Test -Analytical Method Délai: Up to 6 months	This analytical method for cobas 4800 BRAF V600 Mutation Test measured the time between receipt of samples to the result determination. It measured the time in days.	Up to 6 months
Technician Work Time Between DNA Extraction and Result by Cobas 4800 BRAF V600 Mutation Test - Analytical Method Délai: Up to 6 months	This cobas 4800 BRAF V600 Mutation Test analytical method measures the working time required by the technician from the time of DNA extraction to the time to obtain the results. The time duration was measured in hours.	Up to 6 months
Management of Discordance- Method Used to Manage Discordance Délai: Up to 6 months	Crossing DNA, DNA from In-House method analysed with cobas, SNaPshot, DNA from cobas analysed with In-House method, external site control test, Sanger sequencing, Kit CE-IVD Therascreen RGQ Qiagen, Kit Therascreen RGQ BRAF + Pyrosequencing by another platform (PF), Pyrosequencing, Mutation detection On Another Block, (primitive tumor [prm. tmr]), Sequencing And Therascreen kit (Qiagen) were used for management of discordance between "in-house" method and Cobas 4800 mutation test.	Up to 6 months
Management of Discordance-Final Result for BRAF V600 Mutation Detection Délai: Up to 6 months	The final results obtained by discordance management of the 28 discordant samples were BRAF V600 mutation, No BRAF V600 mutation and Non-evaluable. These results were further assessed by the Investigator and interpreted as final result.	Up to 6 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hoffmann-La Roche

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2012

Achèvement primaire (Réel)

1 avril 2013

Achèvement de l'étude (Réel)

1 avril 2013

Dates d'inscription aux études

Première soumission

6 décembre 2012

Première soumission répondant aux critères de contrôle qualité

6 décembre 2012

Première publication (Estimation)

7 décembre 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

28 mars 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 février 2016

Dernière vérification

1 novembre 2015

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

ML28471

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