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

torstai 25. helmikuuta 2016 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Pahanlaatuinen melanooma

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Todellinen)

420

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

Lapsi
Aikuinen
Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Sukupuolet, jotka voivat opiskella

Kaikki

Näytteenottomenetelmä

Todennäköisyysnäyte

Tutkimusväestö

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

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Ryhmien/kohorttien lukumäärä

Kohortit ja interventiot

Ryhmä/Kohortti
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

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus	Toimenpiteen kuvaus	Aikaikkuna
BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus	Toimenpiteen kuvaus	Aikaikkuna
Tumor Sample Characteristics-Type of Tumor Sample Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: Up to 6 months	Median DNA elution volume microliters [mcl] was reported.	Up to 6 months
Mean DNA Concentration by Pre-analytical Method Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Hoffmann-La Roche

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.

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