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

Multiple Synchronous Lung Cancers (MSLCs) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03795155
• Other study ID #: RenJiH-2018-056
• Status: Recruiting
• Start date: December 1, 2018
• Est. completion date: November 30, 2023

Study information

• Verified date: June 2020
• Source: RenJi Hospital
• Contact: Pengfei Ma, Ph.D.
• Phone: +8613671806647
• Email: pengfei0820[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Multiple Synchronous Lung Cancers (MSLCs)

Locations

Country	Name	City	State
China	Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Ma P, Fu Y, Cai MC, Yan Y, Jing Y, Zhang S, Chen M, Wu J, Shen Y, Zhu L, Chen HZ, Gao WQ, Wang M, Gu Z, Bivona TG, Zhao X, Zhuang G. Simultaneous evolutionary expansion and constraint of genomic heterogeneity in multifocal lung cancer. Nat Commun. 2017 Oct 10;8(1):823. doi: 10.1038/s41467-017-00963-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genomic characters of synchronous lessions in each MSLC patient	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.	November 30, 2021