Evolution of Multiple Primary Lung Cancer (Evolution)

• Conditions: Multiple Primary Lung Cancers; Lung Cancer; Non Small Cell Lung Cancer

• Registration Number: NCT04326751
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Last Update Submitted: 2020-03-26
• Study First Posted: 2020-03-30
• Last Update Posted: 2020-03-30
• Study Start: 2021-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor heterogeneity of multiple primary lung cancer	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	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between ctDNA and clonal variation	3 year	Explore the correlation between the detection rate of ctDNA and subclonal mutations of different tumor sites detected by genetic analysis.
Correlation between ctDNA and tumor burden	3 year	Explore the correlation between the detection rate of ctDNA and tumor burden.