Survival Validation and Gene Mutations of N Descriptors i... | NCT06349252

Studies
Survival Validation and Gene Mutations of N Descriptors in the Ninth Edition of the TNM Classification for Lung Cancer

NCT06349252

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Apr 5, 2024Actual

Enrollment

1,263Estimated

Phase

Not provided

Conditions

Non-small Cell Lung Cancer

Interventions

Radical resection

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

Mar 2024

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

Jan 1, 2021Actual

Primary Completion Date

Aug 1, 2024Estimated

Completion Date

Jan 1, 2025Estimated

First Submitted Date

Mar 31, 2024

First Submission Date that Met QC Criteria

Mar 31, 2024

First Posted Date

Apr 5, 2024Actual

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 31, 2024

Last Update Posted Date

Apr 5, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Haiquan Chen, The director of the department of thoracic surgery, Fudan UniversityPrincipal Investigator

Lead Sponsor

Fudan UniversityOTHER

Collaborators

Not provided

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

The International Association for the Study of Lung Cancer Staging Committee recently unveiled the ninth edition of TNM staging system for lung cancer. This study aims to explore survival outcomes, stage grouping, and gene mutations in N descriptors of this new classification system.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

1,263Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radical resection	Procedure	Patients should undergo radical resection.

Measure	Description	Time Frame
Overall Survival		Five year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathological N2.

Exclusion Criteria:

Patients undergoing neoadjuvant chemotherapy

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients diagnosed with pathological N2 non-small cell lung cancer based on the eighth TNM staging system in Fudan University Shanghai Cancer Center.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fangqiu Fu, MD	Contact	+86-13122677592		fufangqiu12@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Cancer Center	Recruiting	Shanghai	Shanghai Municipality	200032	China

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