A Real World Study Based on NGS (TRUMPRWS)

Recruiting

• Conditions: Non-Small Cell Carcinoma of Lung, TNM Stage 4

• Registration Number: NCT03605602
• Lead Sponsor: Guangdong Association of Clinical Trials

Brief Summary

This is a descriptive observational study, in which data are collected in an epidemiological fashion. This study does not intend to alter or intervene the current medical practice of the recruited patients. Data will be collected in prospective manner.

Detailed Description

This is a descriptive observational study, in which data are collected in an epidemiological fashion. This study does not intend to alter or intervene the current medical practice of the recruited patients. Data will be collected in prospective manner.

The eligible patients will be recruited after NGS analysis for tumor tissue and the inform-consent is obtained. The study required information will be collected (every 3 months).

Study Timeline

• Study First Submitted: 2018-07-05
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-07-30
• Study Start: 2018-08-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07
• Primary Completion: 2022-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2700

Inclusion Criteria

1. Patients must be ≥20 years of age.
2. Provision of fully informed consent prior to any study specific procedures.
3. Histologically or cytologically confirmed, unresectable stage IIIB or stage IV NSCLC.
4. Genetic variants of tumor tissue detected by NGS.

Exclusion Criteria

None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical relevance between genomic profiling and overall survival	[ Time Frame: From registration onto that step until death, or censored at the date of last contact, assessed up to 3 years]	Kaplan-meier analysis of overall survival based on different genetic alteration

Secondary Outcome Measures

Name	Time	Method
The characteristics of genomic variation and dynamic changes during different anti-tumor treatment	24 months	Subtypes, incidence and dynamic changes of genomic variants during treatment process.

Trial Locations

Locations (1)

Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology; 🇨🇳 Guangzhou, Guangdong, China