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

NCT ID: NCT03795155

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2023-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Synchronous Lung Cancers (MSLCs)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xiaojing Zhao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ren Ji Hospital

Yujie Fu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ren Ji Hospital

Guanglei Zhuang, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ren Ji Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pengfei Ma, Ph.D.

Role: CONTACT

+8613671806647

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Pengfei Ma, Ph.D.

Role: primary

+8613671806647

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29018192 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RenJiH-2018-056

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Molecular Profiling Project
NCT04025515 RECRUITING
Prospective Clinicogenomic Program
NCT04180176 COMPLETED PHASE4