Multiple Primary Lung CancersNCT04326751
Evolution of Multiple Primary Lung Cancer (Evolution)
An observational study of Multiple Primary Lung Cancers and Lung Cancer, run by Peking University People's Hospital.
Trial summary
To investigate the evolutionary genomic landscape, explore the genetic tumor heterogeneity and microenvironment of multiple primary lung cancer (MPLC) by using tissue genetic analysis and circulating tumor DNA detection, in order to provide robust evidence for the diagnosis, treatment, and surveillance of MPLC. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Primary Lung Cancers, Lung Cancer, Non Small Cell Lung Cancer
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 31 Dec 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histologically confirmed multiple lung cancer patients who will receive surgical therapy
Who may be able to join
- Aged 18 to 80 years
- Patients who are clinically diagnosed multiple lung cancers, and undergo surgical treatment.
- No history of any malignancy in recent 5 years.
- No chemotherapy, radiotherapy or targeted therapy will be performed before surgery.
- Surgical removal of at least 2 tumors confirmed to be lung cancer postoperatively by pathologic evaluation.
Who cannot join
- All lesions present as pure ground-glass opacities (GGOs) on CT scans.
- Patients who do not undergo R0 resection (including tumors located bilaterally but only unilaterally resected).
- Unqualified blood samples.
- Unable to comply with the study procedure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Genetic Evolution and Microenvironment of Multiple Primary Lung Cancer
To investigate the evolutionary genomic landscape, explore the genetic tumor heterogeneity and microenvironment of multiple primary lung cancer (MPLC) by using tissue genetic analysis and circulating tumor DNA detection, in order to provide robust evidence for the diagnosis, treatment, and surveillance of MPLC.
Read the detailed description
Multiple primary lung cancer (MPLC) has become a worldwide problem due to the difficulty in diagnosis, treatment and surveillance. Although exploring tumour clonal heterogeneity and microenvironment can help understand cancer evolution and impact therapeutic outcome, study is still lacking in this field on MPLC. Circulating tumor DNA (ctDNA) are short DNA fragments, which can be obtained conveniently and non-invasively, providing comprehensive views of the tumor as were shed by tumor cells from multiple tumor regions. Therefore, we design a prospective study of patients with surgically treated MPLC, aiming to use ctDNA technique to define the evolutionary landscape of MPLC through inter-tumor and intra-tumor heterogeneity by multi-region sampling and genetic analysis. We will also explore the the microenvironment by RNA sequencing and T cell receptor sequencing. This study may help understand the genetic evolution and microenvironment of MPLC, and provide evidence for the diagnosis, treatment and surveillance of these patients.
- Keywords
- multiple primary lung cancer, ctDNA, evolution, tumor heterogeneity, microenvironment
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor heterogeneity of multiple primary lung cancer
Explore the intra-tumor and inter-tumor genetic heterogeneity by analysis of clonal and subclonal mutations detected by ctDNA.
Measured: 3 year
Microenvironment of multiple primary lung cancer
Using RNA sequencing and T cell receptor (TCR) sequencing to evaluate the microenvironment of each lesion of multiple primary lung cancer, including T cell receptpr clonality ,diversity , evenness, and richness.
Measured: 3 year
Secondary outcomes (2)
Correlation between ctDNA and clonal variation
Explore the correlation between the detection rate of ctDNA and subclonal mutations of different tumor sites detected by genetic analysis.
Measured: 3 year
Correlation between ctDNA and tumor burden
Explore the correlation between the detection rate of ctDNA and tumor burden.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Primary Lung CancersStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Medical Examination Institute Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jun Wang, M.D., Study chair, Peking University People's Hospital Thoracic Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326751
- Sponsor's protocol ID
- PTHO2002
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Genetic Evolution and Microenvironment of Multiple Primary Lung Cancer
- ClinicalTrials.gov ID
- NCT04326751
- Acronym / sponsor ID
- PTHO2002
- Keywords
- multiple primary lung cancer, ctDNA, evolution, tumor heterogeneity, microenvironment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Guangzhou Burning Rock Medical Examination Institute Co., Ltd.
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Mar 2020 (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.
To investigate the evolutionary genomic landscape, explore the genetic tumor heterogeneity and microenvironment of multiple primary lung cancer (MPLC) by using tissue genetic analysis and circulating tumor DNA detection, in order to provide robust evidence for the diagnosis, treatment, and surveillance of MPLC.
Detailed description
Multiple primary lung cancer (MPLC) has become a worldwide problem due to the difficulty in diagnosis, treatment and surveillance. Although exploring tumour clonal heterogeneity and microenvironment can help understand cancer evolution and impact therapeutic outcome, study is still lacking in this field on MPLC. Circulating tumor DNA (ctDNA) are short DNA fragments, which can be obtained conveniently and non-invasively, providing comprehensive views of the tumor as were shed by tumor cells from multiple tumor regions. Therefore, we design a prospective study of patients with surgically treated MPLC, aiming to use ctDNA technique to define the evolutionary landscape of MPLC through inter-tumor and intra-tumor heterogeneity by multi-region sampling and genetic analysis. We will also explore the the microenvironment by RNA sequencing and T cell receptor sequencing. This study may help understand the genetic evolution and microenvironment of MPLC, and provide evidence for the diagnosis, treatment and surveillance of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically confirmed multiple lung cancer patients who will receive surgical therapy
Key inclusion criteria (5 listed)
- Aged 18 to 80 years
Key exclusion criteria (4 listed)
- All lesions present as pure ground-glass opacities (GGOs) on CT scans.
- Patients who do not undergo R0 resection (including tumors located bilaterally but only unilaterally resected).
- Unqualified blood samples.
- Unable to comply with the study procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor heterogeneity of multiple primary lung cancer
Time frame: 3 year
Explore the intra-tumor and inter-tumor genetic heterogeneity by analysis of clonal and subclonal mutations detected by ctDNA.
Microenvironment of multiple primary lung cancer
Time frame: 3 year
Using RNA sequencing and T cell receptor (TCR) sequencing to evaluate the microenvironment of each lesion of multiple primary lung cancer, including T cell receptpr clonality ,diversity , evenness, and richness.
2 secondary outcomes
Correlation between ctDNA and clonal variation
Time frame: 3 year
Correlation between ctDNA and tumor burden
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
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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.
Jun Wang, M.D. study chair
Peking University People's Hospital Thoracic Surgery Department
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Primary Lung Cancers and Lung Cancer, run by Peking University People's Hospital.
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 5 inclusion and 4 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 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Kezhong Chen, M.D. ((+86)13488752289, mdkzchen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor heterogeneity of multiple primary lung cancer (time frame: 3 year). The study lists 2 primary outcomes in all. 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 30 Mar 2020.