Comparison of In-House Methods and Cobas BRAF V600 Mutation Assay in Melanoma Tumor Samples
25 febbraio 2016 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Osservativo
Iscrizione (Effettivo)
420
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Boulogne Billancourt, Francia, 92104
-
Colmar, Francia, 68024
-
Lille, Francia, 59037
-
Lyon, Francia, 69437
-
Marseille, Francia, 13015
-
Montpellier, Francia, 34295
-
Nantes, Francia, 44093
-
Paris, Francia, 75010
-
Pessac, Francia, 33604
-
Rouen, Francia, 76031
-
Vandoeuvre Les Nancy, Francia, 54511
-
Villejuif, Francia, 94505
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione di probabilità
Popolazione di studio
No patients are enrolled in this study.
Use of melanoma tumor samples.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Tumor Sample Characteristics-Type of Tumor Sample
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to 6 months
|
Median DNA elution volume microliters [mcl] was reported.
|
Up to 6 months
|
|
Mean DNA Concentration by Pre-analytical Method
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 dicembre 2012
Completamento primario (Effettivo)
1 aprile 2013
Completamento dello studio (Effettivo)
1 aprile 2013
Date di iscrizione allo studio
Primo inviato
6 dicembre 2012
Primo inviato che soddisfa i criteri di controllo qualità
6 dicembre 2012
Primo Inserito (Stima)
7 dicembre 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
28 marzo 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 febbraio 2016
Ultimo verificato
1 novembre 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ML28471
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .