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Evolution of Multiple Primary Lung Cancer (Evolution)

The Genetic Evolution and Microenvironment of Multiple Primary Lung Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04326751
Enrollment
20
Registered
2020-03-30
Start date
2021-01-01
Completion date
2023-12-31
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Multiple Primary Lung Cancers, Non Small Cell Lung Cancer

Keywords

multiple primary lung cancer, ctDNA, evolution, tumor heterogeneity, microenvironment

Brief 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.

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.

Interventions

None listed

Sponsors

Guangzhou Burning Rock Medical Examination Institute Co., Ltd.
CollaboratorINDUSTRY
Peking University People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Aged 18 to 80 years 1. Patients who are clinically diagnosed multiple lung cancers, and undergo surgical treatment. 2. No history of any malignancy in recent 5 years. 3. No chemotherapy, radiotherapy or targeted therapy will be performed before surgery. 4. Surgical removal of at least 2 tumors confirmed to be lung cancer postoperatively by pathologic evaluation.

Exclusion criteria

1. All lesions present as pure ground-glass opacities (GGOs) on CT scans. 2. Patients who do not undergo R0 resection (including tumors located bilaterally but only unilaterally resected). 3. Unqualified blood samples. 4. Unable to comply with the study procedure

Design outcomes

Primary

MeasureTime frameDescription
Tumor heterogeneity of multiple primary lung cancer3 yearExplore the intra-tumor and inter-tumor genetic heterogeneity by analysis of clonal and subclonal mutations detected by ctDNA.
Microenvironment of multiple primary lung cancer3 yearUsing 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.

Secondary

MeasureTime frameDescription
Correlation between ctDNA and clonal variation3 yearExplore the correlation between the detection rate of ctDNA and subclonal mutations of different tumor sites detected by genetic analysis.
Correlation between ctDNA and tumor burden3 yearExplore the correlation between the detection rate of ctDNA and tumor burden.

Contacts

Primary ContactKezhong Chen, M.D.
mdkzchen@163.com(+86)13488752289

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026