Status:
COMPLETED
Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients
Lead Sponsor:
Genetron Health
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
Harbin Medical University
Conditions:
GIST
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
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...
Eligibility Criteria
Inclusion
- 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.
- The sample should have corresponding basic clinical information, including: the patient's unique traceability number, age, gender, pathological diagnosis results, etc.
- 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.
- The content of tumor cells meets the requirements of assessment reagents and comparison methods.
Exclusion
- 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.
- Samples that cannot complete the entire testing process.
- Patients with incomplete sample information.
Key Trial Info
Start Date :
November 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 25 2021
Estimated Enrollment :
1041 Patients enrolled
Trial Details
Trial ID
NCT05400018
Start Date
November 20 2020
End Date
February 25 2021
Last Update
June 6 2022
Active Locations (3)
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1
Peking University Cancer Hospital
Beijing, China
2
Harbin Medical University Cancer Hospital
Harbin, China
3
Shanghai Tenth People's Hospital
Shanghai, China