Prospective Genomics Initiative on Multiple Synchronous L... | NCT03795155

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

NCT03795155

Sponsor

RenJi Hospital

Status

Unknown status

Last Update Posted

Jun 11, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Multiple Synchronous Lung Cancers (MSLCs)

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2018Actual

Primary Completion Date

Nov 30, 2022Estimated

Completion Date

Nov 30, 2023Estimated

First Submitted Date

Jan 2, 2019

First Submission Date that Met QC Criteria

Jan 3, 2019

First Posted Date

Jan 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2020

Last Update Posted Date

Jun 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Clinical diagnosis of multiple synchronous lung cancers (MSLCs)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pengfei Ma, Ph.D.	Contact	+8613671806647		pengfei0820@163.com

Overall Officials

Name	Affiliation	Role
Xiaojing Zhao, M.D.	Ren Ji Hospital	Principal Investigator
Yujie Fu, Ph.D.	Ren Ji Hospital	Principal Investigator
Guanglei Zhuang, Ph.D.

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University	Recruiting	Shanghai	Shanghai Municipality	200127	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29018192	Background	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.