Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients

Genetron Health

Status: Completed

Conditions: Gastrointestinal Stromal Tumors; GIST

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05400018

20200196

Details and patient eligibility

About

The purpose of this trail is to evaluate the performance of Genetron D842V PCR kit in GIST patients using real-time PCR method.

Full 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.

Enrollment: 1,041 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design