Table 1

Six categories of gene mentions in clinical trial documents.

Category

Definition

Examples


ID

Stage I

Stage II


1

Gene-related

Genetic lesion detected

Genetic lesion status is detected.

• Positive EGFR mutation test...

• Patient with EGFR positive ...



2

Genetic lesion not detected

Genetic lesion status is Not Detected.

• ...negative staining for Kit.

• Patient must have wild type KRAS.



3

Genetic lesion mentioned

Analysis of genetic lesion is mentioned but not particular results

• BRAF - gene analysis of archival tissue

• mutational analysis of genes such as EGFR ...



4

Gene only

It refers to the gene entity only, no status is associated.

• KIT is a gene that codes for ...

• WT1 is a protein in cancer cells that regulates gene expression and ...


5

Drug

Gene related drugs, drug classes, or other therapy

• WT1 Peptide Vaccination in Carcinomas.

• Prior treatment with EGFR inhibitor chemotherapy...


6

Others

None of the above classes, e.g., English words,

• ...using the kit and testing procedures.

• Criteria are met.


Wu et al. BMC Genomics 2012 13(Suppl 8):S21   doi:10.1186/1471-2164-13-S8-S21

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