Multiomics Tumor Evolution Model of NSCLC | NCT05352035

Studies
Multiomics Tumor Evolution Model of NSCLC

NCT05352035

Sponsor

Peking University People's Hospital

Status

Recruiting

Last Update Posted

Apr 30, 2025Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Non-small Cell Lung Cancer

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

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2022Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Apr 23, 2022

First Submission Date that Met QC Criteria

Apr 23, 2022

First Posted Date

Apr 28, 2022Actual

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

Apr 27, 2025

Last Update Posted Date

Apr 30, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jun Wang, Member of the Chinese Academy of Engineering, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Name	Class
Chinese Academy of Medical Sciences	OTHER

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

The purpose of this study is to determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the overall prognosis.

Detailed Description

Lung cancer is the leading cause of cancer-related death globally. Non-small cell lung cancer (NSCLC) accounts for 85% of lung cancer and surgery is still the main treatment strategy. This study will determine the evolutionary mechanism of early-stage non-small cell lung cancer and establish an accurate prognostic model and a recurrence monitoring system by multiomics analysis, which can be helpful for the individual and whole management of lung cancer patients and improve the overall prognosis.

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

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prospective cohort		This cohort will enroll a total of 300 patients prospectively

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease-free survival (DFS)	Time from randomization to disease recurrence or death from any cause.	Through study completion, an average of 2 years
Overall survival (OS)	Time from randomization to death from any cause.	Through study completion, an average of 2 years

Secondary Outcomes

Measure	Description	Time Frame
Relationship between translational biomarkers and clinical outcome	To evaluate if the translational biomarkers can be prediction tools for the clinical outcomes.	Through study completion, an average of 2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years old;
Early-stage NSCLC patients underwent radical surgical resection;
Sufficient tumor tissue and blood sample for study use;
Available clinical-pathologic data, imaging data and follow-up date;
Written informed consent.

Exclusion Criteria:

History of other malignant tumors;
Evidence of distant metastasis before surgery;
Insufficient tumor tissue or blood sample for study use;
Clinical-pathologic data, imaging data or follow-up date is not available;
Other judgments by the Investigator that the patient should not participate in the study.

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

Patients who meet the eligibility criteria will be included consecutively.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kezhong Chen, M.D.	Contact	+86-010-88326657		chenkezhong@pkuph.edu.cn
Wenxiang Wang	Contact	+86-010-88326657		wangwenxiang@stu.pku.edu.cn

Overall Officials

Name	Affiliation	Role
Jun Wang	Peking University People's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University People's Hospital	Recruiting	Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided