Evolution of Multiple Primary Lung Cancer (Evolution)

NCT ID: NCT04326751

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Burning Rock Medical Examination Institute Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Wang, M.D.

Role: STUDY_CHAIR

Peking University People's Hospital Thoracic Surgery Department

Central Contacts

Kezhong Chen, M.D.

Role: CONTACT

mdkzchen@163.com

(+86)13488752289

Other Identifiers

PTHO2002

Identifier Type: -

Identifier Source: org_study_id