Clinical Evaluation of Genetron Lung Cancer Panel in Non-small Cell Lung Cancer Patients

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Clinical Evaluation of Genetron Lung Cancer Panel in Non-small Cell Lung Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05023746
• Other study ID #: 2019071915080046
• Status: Completed
• Start date: August 30, 2018
• Est. completion date: September 17, 2019

Study information

• Verified date: August 2021
• 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 lung cancer panel in non-small cell lung cancer patients using semiconductor sequencing method.

Description:

This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron lung cancer panel and comparison methods. The detection results are compared, and the samples that are inconsistent with the detection results of similar products on the market are reviewed by the the Sanger sequencing method, when the site detection results compared with Sanger sequencing method are inconsistent, Sanger's detection results are recognized. The safety and effectiveness of this panel are confirmed and evaluated. Meanwhile, the accuracy of this panel for the following drug companion diagnostic tests: EGFR gene 19 exon deletion and L858R point mutation in gefitinib tablets, erlotinib hydrochloride and icotinib hydrochloride tablets, T790M point mutation in methanesulfonate acid osimertinib tablets, ALK gene fusion in crizotinib capsules. The results were determined independently according to the cutoff values or interpretation requirements provided by each method, and relevant statistics were used to evaluate clinical application performance of Genetron lung cancer panel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1052
• Est. completion date: September 17, 2019
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Cancer samClinically diagnosed as non-small cell lung samples (mainly lung adenocarcinoma and some lung squamous cell carcinoma, adenosquamous carcinoma, large cell carcinoma, etc.), and a small number of other cancer types are enrolled as interference samples.

2. Collect some samples of relevant medical information before and after the use of targeted drugs. This part of the samples should have relevant previous molecular diagnosis results.

3. Able to provide samples in time according to the requirements of the plan: samples for DNA/RNA extraction: 10 pieces of 10 µm thickness for each sample or 10 pieces of paraffin rolls. Samples for FISH experiment: 5 slices of 3-4µm thickness.

4. The pathological examination conforms to the types of tissue samples listed in the above table. The HE staining results show that the tumor content is not less than 50%, and the paraffin slice damage should be avoided.

5. The sample should have corresponding basic clinical information, including: patient visiting number/medical record number/specimen number, age, gender, pathological diagnosis result, molecular diagnosis result (if any).

Exclusion Criteria:

• Those who do not meet any of the above conditions are excluded. Reason: The included non-small cell lung adenocarcinoma samples and normal samples should have statistical significance, and the conclusions obtained should be scientific and valid. The selection of subjects for this study, while excluding research-related influencing factors, has no adverse effect on the health of the subjects.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Diagnostic Test:
• Genetron lung cancer panel
Follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron lung cancer panel and comparison methods. The detection results are compared, and the samples that are inconsistent with the detection results of similar products on the market are reviewed by the the Sanger sequencing method, when the site detection results compared with Sanger sequencing method are inconsistent, Sanger's detection results are recognized. The results were determined independently according to the cutoff values or interpretation requirements provided by each method, and relevant statistics were used to evaluate clinical application performance of Genetron lung cancer panel.

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing
China	The First Hospital of Jilin University	Jilin
China	The Second Affiliated Hospital Zhejiang University School of Medcine	Zhejiang
China	Henan Cancer Hospital	Zhengzhou

Sponsors (6)

Lead Sponsor	Collaborator
Genetron Health	Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Genetron Health (Beijing) Co., Ltd., Henan Cancer Hospital, The First Hospital of Jilin University, The Second Affiliated Hospital Zhejiang University School of Medcine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Genetron Lung Cancer Panel	The main purpose of this study is: by evaluating the Genetron Lung Cancer Panel to compare the results of simultaneous detection with similar products on the market and the Sanger sequencing method, and to calculate the coincidence rate and consistency of the panel and the comparison method.	2 months