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

2016年2月25日更新者：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.

調査の概要

状態

完了

条件

悪性黒色腫

研究の種類

観察的

入学 (実際)

420

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

子
大人
高齢者

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

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

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
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

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Tumor Sample Characteristics-Type of Tumor Sample 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：Up to 6 months	Median DNA elution volume microliters [mcl] was reported.	Up to 6 months
Mean DNA Concentration by Pre-analytical Method 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hoffmann-La Roche

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2012年12月1日

一次修了 (実際)

2013年4月1日

研究の完了 (実際)

2013年4月1日

試験登録日

最初に提出

2012年12月6日

QC基準を満たした最初の提出物