Non-Small Cell Carcinoma of Lung, TNM Stage 4TRUMPRWSNCT03605602
A Real World Study Based on NGS (TRUMPRWS)
An observational study of Non-Small Cell Carcinoma of Lung, TNM Stage 4, run by Guangdong Association of Clinical Trials at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Carcinoma of Lung, TNM Stage 4
- What is being tested?
- No treatment is included in this protocol.
- How many people
- 2,700 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 30 Dec 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histologically or cytologically confirmed NSCLC
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
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
Yi-Long Wu, Professor, +862083827812, syylwu@live.cn
Xiao-Yan Bai, Dr., +86 15347435499, 799836599@qq.com
About this study
Official title: 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.
Read the 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).
- Being tested
- No treatment is included in this protocol.
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment is included in this protocol.Other
No drug intervention or tissue sampling will be included in this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical relevance between genomic profiling and overall survival
Kaplan-meier analysis of overall survival based on different genetic alteration
Measured: [ 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
Subtypes, incidence and dynamic changes of genomic variants during treatment process.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Aug 2018
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Carcinoma of Lung, TNM Stage 4Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,700 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Long Wu, Professor, Study chair, Guangdong Association of Clinical Trials (GACT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605602
- Sponsor's protocol ID
- CTONG1705
- Acronym
- TRUMPRWS
- Status last verified
- Feb 2020
- First submitted
- 5 Jul 2018
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37488286Liu 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.
PubMed 35659479
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRUMPRWS: A Non-interventional Study on Genetic Variants and Its Clinical Relevance in Chinese Patients With Advanced NSCLC (TRUMPRWS)
- ClinicalTrials.gov ID
- NCT03605602
- Acronym / sponsor ID
- TRUMPRWS / CTONG1705
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,700 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically or cytologically confirmed NSCLC
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No treatment is included in this protocol.No drug intervention or tissue sampling will be included in this study. | Other | – |
Primary outcome
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
1 secondary outcome
The characteristics of genomic variation and dynamic changes during different anti-tumor treatment
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Derived from this study: PubMed 37488286Liu 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.
- Derived from this study: PubMed 35659479Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Long Wu, Professor study chair
Guangdong Association of Clinical Trials (GACT)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Carcinoma of Lung, TNM Stage 4, run by Guangdong Association of Clinical Trials at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Long Wu, Professor (+86 20 83827812, syylwu@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03605602, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.