Evolution of Multiple Primary Lung Cancer (Evolution)

Lung Cancer Clinical Trial

Official title:

The Genetic Evolution and Microenvironment of Multiple Primary Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04326751
• Other study ID #: PTHO2002
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2020
• Source: Peking University People's Hospital
• Contact: Kezhong Chen, M.D.
• Phone: (+86)13488752289
• Email: mdkzchen[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Multiple Primary Lung Cancers
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 year
Primary	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.	3 year
Secondary	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.	3 year
Secondary	Correlation between ctDNA and tumor burden	Explore the correlation between the detection rate of ctDNA and tumor burden.	3 year