Prospective Genomics Initiative on Multiple Synchronous Lung Cancer (PGI-MSLC)

• Conditions: Multiple Synchronous Lung Cancers (MSLCs)

• Registration Number: NCT03795155
• Lead Sponsor: RenJi Hospital

Brief Summary

This prospective study is to characterize the genomic landscape and genetic heterogeneity of multiple synchronous lung cancer (MSLC) in correlation with comprehensive clinical, histopathological and medical imaging information, in order to improve disease diagnosis and tailored treatment for MSLC patients.

Detailed Description

* To initiate a prospective registry of MSLC patients with high-quality clinical samples and detailed medical data.

* To define the clonal relationship, genomic landscape and potential driver alterations of MSLC using whole-genome sequencing.

* To determine the intrapatient and intratumor genetic heterogeneity of MSLC.

* To correlate molecular features with clinical parameters and patient outcome.

* To serve as a continuous infrastructure for a large variety of research purposes including: A. Diagnostic research B. Prognostic research C. Biological research D. Interventional trial design testing new therapies in MSLC.

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-07
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-11
• Primary Completion: 2022-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age 18 years or older
• Confirmed diagnosis of multiple synchronous lung cancers (MSLCs) without metastatic disease
• Signed informed consent

Exclusion Criteria

• Medical or psychiatric condition that would preclude informed consent
• History of known high-risk infections
• With metastatic tumors except lung

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genomic characters of synchronous lessions in each MSLC patient	November 30, 2021	Whole-genome sequencing reveals the mutation, copy number variation and structure variation of MSLCs. We will analysis the genomic characters of synchronous lesions in each MSLC patient.

Trial Locations

Locations (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China