A Real World Study Based on NGS (TRUMPRWS) (TRUMPRWS)

February 6, 2020 updated by: Guangdong Association of Clinical Trials

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yi-Long Wu, Professor
  • Phone Number: +86 20 83827812
  • Email: syylwu@live.cn

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology
        • Contact:
          • Yi-Long Wu, Professor
          • Phone Number: +862083827812
          • Email: syylwu@live.cn
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Histologically or cytologically confirmed NSCLC

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical relevance between genomic profiling and overall survival
Time Frame: [ 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
[ Time Frame: From registration onto that step until death, or censored at the date of last contact, assessed up to 3 years]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The characteristics of genomic variation and dynamic changes during different anti-tumor treatment
Time Frame: 24 months
Subtypes, incidence and dynamic changes of genomic variants during treatment process.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Association of Clinical Trials

Investigators

  • Study Chair: Yi-Long Wu, Professor, Guangdong Association of Clinical Trials (GACT)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

July 5, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

July 30, 2018

Study Record Updates

Last Update Posted (Actual)

February 7, 2020

Last Update Submitted That Met QC Criteria

February 6, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTONG1705

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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