Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients

Completed

• Conditions: GIST; Gastrointestinal Stromal Tumors

• Registration Number: NCT05400018
• Lead Sponsor: Genetron Health

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 Timeline

• Study Start: 2020-11-20
• Primary Completion: 2021-02-25
• Study Completion: 2021-02-25
• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-26
• Status Verified: 2022-06
• Study First Posted: 2022-06-01
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1041

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ct Value (Ct Values From PCR Reaction)	3 months	the number of PCR cycles where the amplification signal starts to be observed

Secondary Outcome Measures

Name	Time	Method
PPV	3 months	the ratio of true positive in all positive 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.
NPV	3 months	the ratio of true negative in all negative cases

Trial Locations

Locations (3)

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, China

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, China

Peking University Cancer Hospital; 🇨🇳 Beijing, China