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Report for Clinical Trial NCT02784639

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Comparison of KRAS/BRAF Mutational Status Between Tumor Tissue Section Analysis With Conventional Techniques and Plasma Samples Analysis (KPLEX2)

The goal of this multicenter prospective study is to validate, and ultimately translate in routine clinical practice, the use of plasma analysis of ccfDNA for the determination of KRAS mutation status in mCRC patients.

NCT02784639 Colorectal Cancer
MeSH:Colorectal Neoplasms
HPO:Neoplasm of the large intestine

2 Interventions

Name: Plasma Analysis of circulating cell free DNA

Type: Other
Group Labels: 1

determination of KRAS mutation

Name: Tumor tissue analysis of circulating cell free DNA

Type: Other
Group Labels: 1

determination of KRAS mutation


Primary Outcomes

Description: Area under the ROC curve of the mutation percentage obtained from plasma ccfDNA analysis

Measure: Area under ROC curve

Time: 12 month

Purpose: Diagnostic

Allocation: N/A

Single Group Assignment


There are 7 SNPs

SNPs


1 G12A

As a consequence, the method was adapted to detect the six more frequent KRAS mutations in CRC (G12D, G12V, G13D, G12S, G12C, G12A) and the BRAF V600E. --- G12D --- --- G12V --- --- G13D --- --- G12S --- --- G12C --- --- G12A ---


2 G12C

As a consequence, the method was adapted to detect the six more frequent KRAS mutations in CRC (G12D, G12V, G13D, G12S, G12C, G12A) and the BRAF V600E. --- G12D --- --- G12V --- --- G13D --- --- G12S --- --- G12C ---


3 G12D

As a consequence, the method was adapted to detect the six more frequent KRAS mutations in CRC (G12D, G12V, G13D, G12S, G12C, G12A) and the BRAF V600E. --- G12D ---


4 G12S

As a consequence, the method was adapted to detect the six more frequent KRAS mutations in CRC (G12D, G12V, G13D, G12S, G12C, G12A) and the BRAF V600E. --- G12D --- --- G12V --- --- G13D --- --- G12S ---


5 G12V

As a consequence, the method was adapted to detect the six more frequent KRAS mutations in CRC (G12D, G12V, G13D, G12S, G12C, G12A) and the BRAF V600E. --- G12D --- --- G12V ---


6 G13D

As a consequence, the method was adapted to detect the six more frequent KRAS mutations in CRC (G12D, G12V, G13D, G12S, G12C, G12A) and the BRAF V600E. --- G12D --- --- G12V --- --- G13D ---


7 V600E

As a consequence, the method was adapted to detect the six more frequent KRAS mutations in CRC (G12D, G12V, G13D, G12S, G12C, G12A) and the BRAF V600E. --- G12D --- --- G12V --- --- G13D --- --- G12S --- --- G12C --- --- G12A --- --- V600E ---

CcfDNA analysis showed 100% specificity and sensitivity for the BRAF V600E mutation. --- V600E ---



HPO Nodes


HPO: