A Real World Study Based on NGS (TRUMPRWS)

NCT03605602 | Unknown DMC

• 1 other identifier: CTONG1705
• Study Type: observational
• Target: 2,700
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Carcinoma of Lung, TNM Stage 4

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The characteristics of genomic variation and dynamic changes during different anti-tumor treatment

  24 months

Interventions

No treatment is included in this protocol. OTHER

No drug intervention or tissue sampling will be included in this study.

Eligibility Criteria

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

Study Population

Histologically or cytologically confirmed NSCLC

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead

Study Sites (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, 510080, China

RECRUITING

Related Publications (2)

• Liu SM, Tu HY, Wei XW, Yan HH, Dong XR, Cui JW, Zhou Z, Xu CR, Zheng MY, Li YS, Wang Z, Bai XY, Li AN, Sun YL, Huang J, Lin JX, Ke EE, Xu BF, Lu C, Du Y, Chen Y, Ma R, Wang BH, Cang SD, Wang BC, Chen HJ, Yang JJ, Li Y, Zhou Q, Wu YL. First-line pyrotinib in advanced HER2-mutant non-small-cell lung cancer: a patient-centric phase 2 trial. Nat Med. 2023 Aug;29(8):2079-2086. doi: 10.1038/s41591-023-02461-x. Epub 2023 Jul 24.

  PMID: 37488286 DERIVED

• Liu SM, Yan HH, Wei XW, Lu C, Dong XR, Du Y, Cui JW, Chen Y, Ma R, Wang BH, Zhou Z, Cang SD, Yang JJ, Tu HY, Zhang XC, Zhong WZ, Zhou Q, Wu YL. Biomarker-Driven Studies With Multi-targets and Multi-drugs by Next-Generation Sequencing for Patients With Non-Small-Cell Lung Cancer: An Open-Label, Multi-center, Phase II Adaptive Umbrella Trial and a Real-World Observational Study (CTONG1702&CTONG1705). Clin Lung Cancer. 2022 Nov;23(7):e395-e399. doi: 10.1016/j.cllc.2022.05.009. Epub 2022 May 11.

  PMID: 35659479 DERIVED

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 Officials

• Yi-Long Wu, Professor

  Guangdong Association of Clinical Trials (GACT)

  STUDY CHAIR

Central Study Contacts

Yi-Long Wu, Professor

CONTACT

+86 20 83827812; syylwu@live.cn

Xiao-Yan Bai, Dr.

CONTACT

+8615347435499; 799836599@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 30, 2018
• Study Start: August 1, 2018
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2024
• Last Updated: February 7, 2020

Record last verified: 2020-02

Locations

CN (1)