Comparison of In-House Methods and Cobas BRAF V600 Mutation Assay in Melanoma Tumor Samples
2016년 2월 25일 업데이트: 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.
연구 개요
상태
완전한
정황
연구 유형
관찰
등록 (실제)
420
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Boulogne Billancourt, 프랑스, 92104
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Colmar, 프랑스, 68024
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Lille, 프랑스, 59037
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Lyon, 프랑스, 69437
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Marseille, 프랑스, 13015
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Montpellier, 프랑스, 34295
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Nantes, 프랑스, 44093
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Paris, 프랑스, 75010
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Pessac, 프랑스, 33604
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Rouen, 프랑스, 76031
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Vandoeuvre Les Nancy, 프랑스, 54511
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Villejuif, 프랑스, 94505
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
No patients are enrolled in this study.
Use of melanoma tumor samples.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Tumor Sample Characteristics-Type of Tumor Sample
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 12월 1일
기본 완료 (실제)
2013년 4월 1일
연구 완료 (실제)
2013년 4월 1일
연구 등록 날짜
최초 제출
2012년 12월 6일
QC 기준을 충족하는 최초 제출
2012년 12월 6일
처음 게시됨 (추정)
2012년 12월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 3월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 2월 25일
마지막으로 확인됨
2015년 11월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ML28471
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