Evolution of Multiple Primary Lung Cancer (Evolution) | NCT04326751

Studies
Evolution of Multiple Primary Lung Cancer (Evolution)

NCT04326751

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Mar 30, 2020Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Multiple Primary Lung Cancers
Lung Cancer
Non Small Cell Lung Cancer

Interventions

Not provided

Countries

Not provided

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

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Estimated

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Mar 26, 2020

First Submission Date that Met QC Criteria

Mar 26, 2020

First Posted Date

Mar 30, 2020Actual

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

Mar 26, 2020

Last Update Posted Date

Mar 30, 2020Actual

Name	Class
Guangzhou Burning Rock Medical Examination Institute Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

To investigate the evolutionary genomic landscape, explore the genetic tumor heterogeneity and microenvironment of multiple primary lung cancer (MPLC) by using tissue genetic analysis and circulating tumor DNA detection, in order to provide robust evidence for the diagnosis, treatment, and surveillance of MPLC.

Detailed Description

Multiple primary lung cancer (MPLC) has become a worldwide problem due to the difficulty in diagnosis, treatment and surveillance. Although exploring tumour clonal heterogeneity and microenvironment can help understand cancer evolution and impact therapeutic outcome, study is still lacking in this field on MPLC. Circulating tumor DNA (ctDNA) are short DNA fragments, which can be obtained conveniently and non-invasively, providing comprehensive views of the tumor as were shed by tumor cells from multiple tumor regions. Therefore, we design a prospective study of patients with surgically treated MPLC, aiming to use ctDNA technique to define the evolutionary landscape of MPLC through inter-tumor and intra-tumor heterogeneity by multi-region sampling and genetic analysis. We will also explore the the microenvironment by RNA sequencing and T cell receptor sequencing. This study may help understand the genetic evolution and microenvironment of MPLC, and provide evidence for the diagnosis, treatment and surveillance of these patients.

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

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tumor heterogeneity of multiple primary lung cancer	Explore the intra-tumor and inter-tumor genetic heterogeneity by analysis of clonal and subclonal mutations detected by ctDNA.	3 year
Microenvironment of multiple primary lung cancer	Using RNA sequencing and T cell receptor (TCR) sequencing to evaluate the microenvironment of each lesion of multiple primary lung cancer, including T cell receptpr clonality ,diversity , evenness, and richness.	3 year

Secondary Outcomes

Measure	Description	Time Frame
Correlation between ctDNA and clonal variation	Explore the correlation between the detection rate of ctDNA and subclonal mutations of different tumor sites detected by genetic analysis.	3 year
Correlation between ctDNA and tumor burden

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18 to 80 years
1. Patients who are clinically diagnosed multiple lung cancers, and undergo surgical treatment.
2. No history of any malignancy in recent 5 years.
3. No chemotherapy, radiotherapy or targeted therapy will be performed before surgery.
4. Surgical removal of at least 2 tumors confirmed to be lung cancer postoperatively by pathologic evaluation.

Exclusion Criteria:

All lesions present as pure ground-glass opacities (GGOs) on CT scans.
Patients who do not undergo R0 resection (including tumors located bilaterally but only unilaterally resected).
Unqualified blood samples.
Unable to comply with the study procedure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Histologically confirmed multiple lung cancer patients who will receive surgical therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kezhong Chen, M.D.	Contact	(+86)13488752289		mdkzchen@163.com

Overall Officials

Name	Affiliation	Role
Jun Wang, M.D.	Peking University People's Hospital Thoracic Surgery Department	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

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