To Evaluate the Correlation Between the Results of Specific Gene Testing and the Efficacy of Targeted Therapy in Patients With NSCLC

NCT05805267 | Completed

• 1 other identifier: CONFIDENCE II
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluated the correlation between the qualitative test results of Xiamen Aide the gene test specified by the test reagent and the efficacy of relevant targeted drugs in patients with non-small cell lung cancery, and the research data is used to support the registration and marketing of the assessment reagent

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)

  2 year

Secondary Outcomes (1)

• ORR

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with non-small cell lung cancer who have previously received or are taking gefitinib (first-line therapy) or osimertinib (post-TKI resistance) or crizotinib monotherapy

You may qualify if:

• )≥18;
• \) advanced non-small cell lung cancer confirmed by histopathology;
• \) Patients with NSCLC who have previously or are taking gefitinib (first-line therapy) or osimertinib (post-TKI resistance) or crizotinib monotherapy, and the response to treatment can be assessed;
• \) Have sufficient FFPE tissue samples within 5 years: 5 large specimens/case; There were 10 puncture specimens/case

You may not qualify if:

• \) Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs;
• )Maintenance therapy if the disease does not progress after treatment with other antitumor methods

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

tissue sample and plasma DNA

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: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: September 20, 2022
• Primary Completion: February 25, 2023
• Study Completion: March 25, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-03

Locations

CN (1)