- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01744860
Comparison of In-House Methods and Cobas BRAF V600 Mutation Assay in Melanoma Tumor Samples
25. februar 2016 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
420
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Boulogne Billancourt, Frankrike, 92104
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Colmar, Frankrike, 68024
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Lille, Frankrike, 59037
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Lyon, Frankrike, 69437
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Marseille, Frankrike, 13015
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Montpellier, Frankrike, 34295
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Nantes, Frankrike, 44093
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Paris, Frankrike, 75010
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Pessac, Frankrike, 33604
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Rouen, Frankrike, 76031
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Vandoeuvre Les Nancy, Frankrike, 54511
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Villejuif, Frankrike, 94505
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
No patients are enrolled in this study.
Use of melanoma tumor samples.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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
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Cobas 4800 Mutation Test
BRAF V600 mutations were analysed using Cobas 4800 mutation test
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories
Tidsramme: Up to 6 months
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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.
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Up to 6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Tumor Sample Characteristics-Type of Tumor Sample
Tidsramme: Up to 6 months
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The type of tumor sample used for evaluation of BRAF V600 mutation whether it was a biopsy or surgical specimen were reported
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Up to 6 months
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Tumor Sample Characteristics - Source of Tumor Sample
Tidsramme: Up to 6 months
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The source of tumor sample for BRAF V600 mutation detection whether taken from internal or external pathology laboratory were reported
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Up to 6 months
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Type of Pathology Laboratory Performing the Fixation or Embedding-Pre-analytical Method
Tidsramme: Up to 6 months
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The external or internal pathology laboratories involved in the process of fixation or embedding of the tumor sample was evaluated.
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Up to 6 months
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Time From Sampling to Fixation- Pre-analytical Method
Tidsramme: Up to 6 months
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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.
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Up to 6 months
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Type of Fixative Used- Pre-analytical Method
Tidsramme: Up to 6 months
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The different types of fixative Excell, formol, alcohol formol acetic acid and other, used to fix the tumor samples were reported.
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Up to 6 months
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Fixation Duration by Pre-analytical Method
Tidsramme: Up to 6 months
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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
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Up to 6 months
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Slice Thickness by Pre-analytical Method
Tidsramme: Up to 6 months
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Slice thickness of all the tumour samples was measured.
The slice thickness was measured in micrometer.
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Up to 6 months
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Dewaxing by Pre-analytical Method
Tidsramme: Up to 6 Months
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Dewaxing is a method to recover the DNA from samples.
Dewaxing information was collected as "Yes, No or Missing"
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Up to 6 Months
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Necrosis Percentage Determination by Pre-analytical Method
Tidsramme: Up to 6 months
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The percentage of necrosis defined as the death of one or more cells in the analysed zone was reported.
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Up to 6 months
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Percentage of Tumor Cells by Pre-analytical Method
Tidsramme: Up to 6 months
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The percentage of tumor cells in the given tumor sample were reported.
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Up to 6 months
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Tumor Samples With Presence of Melanin by Pre-analytical Method
Tidsramme: Up to 6 months
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The tumor samples with presence of melanin were categorized as Important, Few, Medium and Absent.
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Up to 6 months
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DNA Extraction - Extraction Method by Pre-analytical Method
Tidsramme: Up to 6 months
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This method assessed DNA from the tumor samples was extracted by Automated method or Manual method.
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Up to 6 months
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Median DNA Elution Volume by Pre-analytical Method
Tidsramme: Up to 6 months
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Median DNA elution volume microliters [mcl] was reported.
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Up to 6 months
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Mean DNA Concentration by Pre-analytical Method
Tidsramme: Up to 6 months
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The DNA concentration in the tissue elute was measured in nanogram per microliter (ng/mcL).
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Up to 6 months
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Amount of DNA by Pre-analytical Method
Tidsramme: Up to 6 months
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The total DNA concentration extracted from the tissue was measured in nanogram (ng).
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Up to 6 months
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Size of Amplicons Used by "In-house" Analytical Method
Tidsramme: Up to 6 months
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The method described the size of amplicon used.
It was measured in base pairs (bp).
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Up to 6 months
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Method of Mutation Detection by "In-house" Analytical Method
Tidsramme: Up to 6 months
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Allele-specific PCR, High Resolution Melting (HRM) + Sanger sequencing, Pyrosequencing, Sanger sequencing, Real time PCR, SNaPshot were used for BRAF V600 mutation detection.
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Up to 6 months
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Number of Samples Punched in In-house Analytical Method
Tidsramme: Up to 6 months
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Total number of samples for whom punch was used in 'in-house analytical' method are reported.
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Up to 6 months
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Mean Number of Slices Per Sample Used for "In-house"- Analytical Method
Tidsramme: Up to 6 months
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The mean of number of slices per sample when no punch was used are reported.
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Up to 6 months
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Median Time Between Receipt of Samples and Determination of Result by "In-house" Analytical Method
Tidsramme: Up to 6 months
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This In-house analytical method measured the time between receipt of samples to the result determination.
It measured the time in days.
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Up to 6 months
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Technician Work Time Between DNA Extraction and Result by "In-house" Analytical Method
Tidsramme: Up to 6 months
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The working time required by the technician from the time of DNA extraction to the time to obtain the results was measured in hours.
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Up to 6 months
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Mean DNA Concentration as Measured by COBAS 4800 BRAF V600 Mutation Test-Analytical Method
Tidsramme: Up to 6 months
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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)
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Up to 6 months
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Punch Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method
Tidsramme: Up to 6 months
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The punch done during Cobas 4800 BRAF V600 Mutation Test on the sample was described as Yes or No.
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Up to 6 months
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Number of Slices Used When No Punch Was Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method
Tidsramme: Up to 6 months
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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.
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Up to 6 months
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Median Time Between Receipt of Sample and Determination of Result by Cobas 4800 BRAF V600 Mutation Test -Analytical Method
Tidsramme: Up to 6 months
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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.
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Up to 6 months
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Technician Work Time Between DNA Extraction and Result by Cobas 4800 BRAF V600 Mutation Test - Analytical Method
Tidsramme: Up to 6 months
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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.
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Up to 6 months
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Management of Discordance- Method Used to Manage Discordance
Tidsramme: Up to 6 months
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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.
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Up to 6 months
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Management of Discordance-Final Result for BRAF V600 Mutation Detection
Tidsramme: Up to 6 months
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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.
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Up to 6 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2012
Primær fullføring (Faktiske)
1. april 2013
Studiet fullført (Faktiske)
1. april 2013
Datoer for studieregistrering
Først innsendt
6. desember 2012
Først innsendt som oppfylte QC-kriteriene
6. desember 2012
Først lagt ut (Anslag)
7. desember 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
28. mars 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. februar 2016
Sist bekreftet
1. november 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ML28471
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