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

NCT05023746 | Completed

• 1 other identifier: 2019071915080046
• Study Type: observational
• Target: 1,052
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Clinically diagnosed as non-small cell lung cancer samples

Diagnostic Test: Genetron lung cancer panel

Interventions

Genetron lung cancer panel DIAGNOSTIC_TEST

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.

Clinically diagnosed as non-small cell lung cancer samples

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital sample

You may qualify if:

• 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.
• 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.
• 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.
• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Location

The First Hospital of Jilin University

Jilin, China

Location

The Second Affiliated Hospital Zhejiang University School of Medcine

Zhejiang, China

Location

Henan Cancer Hospital

Zhengzhou, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 27, 2021
• Study Start: August 30, 2018
• Primary Completion: September 9, 2019
• Study Completion: September 17, 2019
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)