Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05400018
• Other study ID #: 20200196
• Status: Completed
• Start date: November 20, 2020
• Est. completion date: February 25, 2021

Study information

• Verified date: June 2022
• Source: Genetron Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1041
• Est. completion date: February 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors
• GIST

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing
China	Harbin Medical University Cancer Hospital	Harbin
China	Shanghai Tenth People's Hospital	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Genetron Health	Beijing Cancer Hospital, Harbin Medical University, Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ct Value (Ct Values From PCR Reaction)	the number of PCR cycles where the amplification signal starts to be observed	3 months
Secondary	PPV	the ratio of true positive in all positive cases	3 months
Secondary	NPV	the ratio of true negative in all negative cases	3 months
Secondary	Consistency (the Overall Ratio of True Positive and True Negative)	The overall consistency ratio of true positive and true negative, i.e. (true positive+true negative)/total number of cases	3 months
Secondary	Kappa coefficient	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.	3 months