Gastrointestinal Stromal Tumors, GIST
Conditions
Brief summary
The purpose of this trail is to evaluate the performance of Genetron D842V PCR kit in GIST patients using real-time PCR method.
Detailed description
This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron D842V PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. The safety and effectiveness of this kit are confirmed and evaluated.
Interventions
None listed
Sponsors
Peking University Cancer Hospital & Institute
Harbin Medical University
Shanghai 10th People's Hospital
Genetron Health
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Paraffin-embedded tissue samples from patients clinically diagnosed with gastrointestinal stromal tumor (GIST), and a small number of other cancers or benign lesions in the gastrointestinal site were included as interference samples. 2. The sample should have corresponding basic clinical information, including: the patient's unique traceability number, age, gender, pathological diagnosis results, etc. 3. The sample is a formalin-fixed paraffin-embedded gastrointestinal stromal tumor tissue sample, and each sample can provide 5 paraffin sections or 5 paraffin rolls with a thickness of at least 5 µm. 4. The content of tumor cells meets the requirements of assessment reagents and comparison methods.
Exclusion criteria
1. The investigator considers that it is not appropriate to continue the clinical trial, such as the samples that are not prepared according to the required steps. 2. Samples that cannot complete the entire testing process. 3. Patients with incomplete sample information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ct Value (Ct Values From PCR Reaction) | 3 months | the number of PCR cycles where the amplification signal starts to be observed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PPV | 3 months | the ratio of true positive in all positive cases |
| NPV | 3 months | the ratio of true negative in all negative cases |
| Consistency (the Overall Ratio of True Positive and True Negative) | 3 months | The overall consistency ratio of true positive and true negative, i.e. (true positive+true negative)/total number of cases |
| Kappa coefficient | 3 months | Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the Genetron D842V PCR kit and sanger sequencing method. |
Countries
China
Outcome results
None listed