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

June 10, 2020 updated by: RenJi Hospital
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:
        • Principal Investigator:
          • Xiaojing Zhao, M.D.
        • Principal Investigator:
          • Yujie Fu, Ph.D.
        • Principal Investigator:
          • Guanglei Zhuang, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinical diagnosis of multiple synchronous lung cancers (MSLCs)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genomic characters of synchronous lessions in each MSLC patient
Time Frame: 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.
November 30, 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Xiaojing Zhao, M.D., Ren Ji Hospital
  • Principal Investigator: Yujie Fu, Ph.D., Ren Ji Hospital
  • Principal Investigator: Guanglei Zhuang, Ph.D., Ren Ji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

November 30, 2023

Study Registration Dates

First Submitted

January 2, 2019

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 7, 2019

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RenJiH-2018-056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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