A Real World Study Based on NGS (TRUMPRWS)

Non-Small Cell Carcinoma of Lung, TNM Stage 4 Clinical Trial

— TRUMPRWS  

Official title:

TRUMPRWS: A Non-interventional Study on Genetic Variants and Its Clinical Relevance in Chinese Patients With Advanced NSCLC (TRUMPRWS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03605602
• Other study ID #: CTONG1705
• Status: Recruiting
• Start date: August 1, 2018
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2020
• Source: Guangdong Association of Clinical Trials
• Contact: Yi-Long Wu, Professor
• Phone: +86 20 83827812
• Email: syylwu[@]live.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2700
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• No treatment is included in this protocol.
No drug intervention or tissue sampling will be included in this study.

Locations

Country	Name	City	State
China	Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Association of Clinical Trials

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical relevance between genomic profiling and overall survival	Kaplan-meier analysis of overall survival based on different genetic alteration	[ Time Frame: From registration onto that step until death, or censored at the date of last contact, assessed up to 3 years]
Secondary	The characteristics of genomic variation and dynamic changes during different anti-tumor treatment	Subtypes, incidence and dynamic changes of genomic variants during treatment process.	24 months