Gene MutationNCT03764371
Effects of Different Genetic Mutations on Prognosis in sMPLC Adenocarcinoma Patients
An observational study of Gene Mutation, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
In 2007 and 2013, the American College of Chest Physicians (ACCP) guidelines applied the diagnostic criteria of sMPLC （synchronous multiple primary lung cancers）, and the diagnostic criteria of Martini and Melamed were extended and developed, Summarized as: (1) different histological types, different genetic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gene Mutation
- What is being tested?
- KAPA Hyper Prep Kit + Agilent SureSelectQXT
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2019to 30 Mar 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators initiated this prospective clinical study to detect lung cancer related genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative pulmonary nodules). At the same time, application of NGS technology to test lung cancer related genes in patients' tumor tissues and blood, patients with lung cancer drive genes were followed up to explore whether different drive genes had an impact on patients' disease progression. In order to investigate the type of gene that causes disease recurrence in patients, tissue or blood test was performed again when disease recurrence occur.
Who may be able to join
- Male or female patients: 18-75 years old;
- ECOG score: 0-1;
- At least two tumors in patients with invasive lung adenocarcinoma at stage I are pathologically confirmed after sMPLC surgery;
- Genetic test is performed on the pathological tissues of the tumor lesions excised, and at least one with driver gene;
- Predicted survival ≥1 year；
- No more than 3 months after sMPLC surgery (last operation);
- Good compliance, family members agree to cooperate to receive survival follow-up;
- Understand and voluntarily sign the informed consent.
Who cannot join
- Previous or co-existing malignant tumors (patients with resected basal cell carcinoma or other carcinoma in situ are not included);
- Systemic anti-tumor therapy, including chemotherapy, radiotherapy or targeted therapy (including but not limited to monoclonal antibodies, small-molecule tyrosine kinase inhibitors, etc.) was used before enrollment.
- Participated in clinical trials of other drugs within 4 weeks
- All the mutations are insignificant to lung cancer;
- The investigator is not sure that the subject will be able to complete the study ( management reasons or others).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first hospital of Jilin University
Changchun, Jilin
Kewei Ma, 13756060506, makw@jlu.edu.cn
Ye Guo, 15844030579, year0904@sina.com
About this study
Official title: A Prospective, Single-center, Phase II Clinical Study of the Effects of Different Genetic Mutations on Prognosis in Multiple Primary Nodular Lung Adenocarcinoma Patients
In 2007 and 2013, the American College of Chest Physicians (ACCP) guidelines applied the diagnostic criteria of sMPLC （synchronous multiple primary lung cancers）, and the diagnostic criteria of Martini and Melamed were extended and developed, Summarized as: (1) different histological types, different genetic characteristics, or different origin of carcinoma in situ; (2) the histological type is the same, the tumor is located in different lung or different lung lobes, the common lymphatic drainage site of lung cancer is not cancerous, and there is no extrapulmonary metastasis at the time of diagnosis.
Postoperative staging of each tumor was carried out in sMPLC patients, if all of them were stage I lung adenocarcinoma, whether adjuvant therapy could fully refer to the treatment principle of stage I NSCLC was considered, whether the benefit of subsequent application of adjuvant chemotherapy was still unclear, and whether adjuvant therapy was needed or not has been determined.
Read more
High-throughput sequencing, also known as "Next generation" sequencing (NGS), is characterized by sequencing of hundreds of thousands to millions of DNA molecules in parallel, and generally shorter reads.For multiple tumor lesions resected by sMPLC, only biopsy gene information from a single cancer focus may not be enough to identify all active driver gene mutations from the tumor. Therefore, NGS sequencing was proposed for all cancer lesions of sMPLC patients to reflect the full picture of gene mutation in such patients.
The investigators initiated this prospective clinical study to detect lung cancer related genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative pulmonary nodules). At the same time, application of NGS technology to test lung cancer related genes in patients' tumor tissues and blood, patients with lung cancer drive genes were followed up to explore whether different drive genes had an impact on patients' disease progression. In order to investigate the type of gene that causes disease recurrence in patients, tissue or blood test was performed again when disease recurrence occur.
- Conditions
- Gene Mutation
- Being tested
- KAPA Hyper Prep Kit + Agilent SureSelectQXT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KAPA Hyper Prep Kit + Agilent SureSelectQXTDiagnostic test
Also called NGS technology
We initiated this prospective clinical study to detect lung cancer related genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative pulmonary nodules). At the same time, application of KAPA Hyper Prep Kit + Agilent SureSelectQXT technology to test lung cancer related genes in patients' tumor tissues and blood, patients with lung cancer drive genes were followed up to explore whether different drive genes had an impact on patients' disease progression. In order to investigate the type of gene that causes disease recurrence in patients, tissue or blood test was performed again when disease recurrence occur.
| Study group | Role | What they receive |
|---|---|---|
| sMPLC | Lung cancer related genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative pulmonary nodules). Receives: Diagnostic Test: KAPA Hyper Prep Kit + Agilent SureSelectQXT |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
Disease-free survival
Measured: Two years
Secondary outcomes (1)
Drive-gene about recurrence
Explore which drive genes are associated with disease recurrence in patients with different drive genes.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start22 Apr 2019
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gene MutationStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764371
- Sponsor's protocol ID
- K2018108
- Status last verified
- Aug 2021
- First submitted
- 28 Nov 2018
- Last updated
- 14 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Phase II Clinical Study of the Effects of Different Genetic Mutations on Prognosis in Multiple Primary Nodular Lung Adenocarcinoma Patients
- ClinicalTrials.gov ID
- NCT03764371
- Acronym / sponsor ID
- K2018108
- Conditions
- Gene Mutation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 5 Dec 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.
In 2007 and 2013, the American College of Chest Physicians (ACCP) guidelines applied the diagnostic criteria of sMPLC （synchronous multiple primary lung cancers）, and the diagnostic criteria of Martini and Melamed were extended and developed, Summarized as: (1) different histological types, different genetic characteristics, or different origin of carcinoma in situ; (2) the histological type is the same, the tumor is located in different lung or different lung lobes, the common lymphatic drainage site of lung cancer is not cancerous, and there is no extrapulmonary metastasis at the time of diagnosis.
Postoperative staging of each tumor was carried out in sMPLC patients, if all of them were stage I lung adenocarcinoma, whether adjuvant therapy could fully refer to the treatment principle of stage I NSCLC was considered, whether the benefit of subsequent application of adjuvant chemotherapy was still unclear, and whether adjuvant therapy was needed or not has been determined.
High-throughput sequencing, also known as "Next generation" sequencing (NGS), is characterized by sequencing of hundreds of thousands to millions of DNA molecules in parallel, and generally shorter reads.For multiple tumor lesions resected by sMPLC, only biopsy gene information from a single cancer focus may not be enough to identify all active driver gene mutations from the tumor. Therefore, NGS sequencing was proposed for all cancer lesions of sMPLC patients to reflect the full picture of gene mutation in such patients.
The investigators initiated this prospective clinical study to detect lung cancer related genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative pulmonary nodules). At the same time, application of NGS technology to test lung cancer related genes in patients' tumor tissues and blood, patients with lung cancer drive genes were followed up to explore whether different drive genes had an impact on patients' disease progression. In order to investigate the type of gene that causes disease recurrence in patients, tissue or blood test was performed again when disease recurrence occur.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sMPLC | – | Diagnostic Test: KAPA Hyper Prep Kit + Agilent SureSelectQXTLung cancer related genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative pulmonary nodules). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators initiated this prospective clinical study to detect lung cancer related genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative pulmonary nodules). At the same time, application of NGS technology to test lung cancer related genes in patients' tumor tissues and blood, patients with lung cancer drive genes were followed up to explore whether different drive genes had an impact on patients' disease progression. In order to investigate the type of gene that causes disease recurrence in patients, tissue or blood test was performed again when disease recurrence occur.
Key inclusion criteria (8 listed)
- Male or female patients: 18-75 years old;
- ECOG score: 0-1;
- At least two tumors in patients with invasive lung adenocarcinoma at stage I are pathologically confirmed after sMPLC surgery;
- Genetic test is performed on the pathological tissues of the tumor lesions excised, and at least one with driver gene;
- Predicted survival ≥1 year；
Key exclusion criteria (5 listed)
- Previous or co-existing malignant tumors (patients with resected basal cell carcinoma or other carcinoma in situ are not included);
- Systemic anti-tumor therapy, including chemotherapy, radiotherapy or targeted therapy (including but not limited to monoclonal antibodies, small-molecule tyrosine kinase inhibitors, etc.) was used before enrollment.
- Participated in clinical trials of other drugs within 4 weeks
- All the mutations are insignificant to lung cancer;
- The investigator is not sure that the subject will be able to complete the study ( management reasons or others).
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 |
|---|---|---|
| KAPA Hyper Prep Kit + Agilent SureSelectQXTAlso: NGS technologyWe initiated this prospective clinical study to detect lung cancer related genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative pulmonary nodules). At the same time, application of KAPA Hyper Prep Kit + Agilent SureSelectQXT technology to test lung cancer related genes in patients' tumor tissues and blood, patients with lung cancer drive genes were followed up to explore whether different drive genes had an impact on patients' disease progression. In order to investigate the type of gene that causes disease recurrence in patients, tissue or blood test was performed again when disease recurrence occur. | Diagnostic test | sMPLC |
Primary outcome
DFS
Time frame: Two years
Disease-free survival
1 secondary outcome
Drive-gene about recurrence
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
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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.
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 Gene Mutation, run by The First Hospital of Jilin University 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 8 inclusion and 5 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 14 Oct 2021. 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 Kewei F Ma (008613756060506, makw@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.