NCT05400018CompletedNot Applicable
Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients
Genetron Health3 sites in 1 country1,041 target enrollmentStarted: November 20, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,041
- Locations
- 3
- Primary Endpoint
- Ct Value (Ct Values From PCR Reaction)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Ct Value (Ct Values From PCR Reaction)
Time Frame: 3 months
the number of PCR cycles where the amplification signal starts to be observed
Secondary Outcomes
- PPV(3 months)
- Consistency (the Overall Ratio of True Positive and True Negative)(3 months)
- Kappa coefficient(3 months)
- NPV(3 months)
Investigators
Study Sites (3)
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