To Evaluate the Correlation Between the Results of Specif... | NCT05805267

Studies
To Evaluate the Correlation Between the Results of Specific Gene Testing and the Efficacy of Targeted Therapy in Patients With NSCLC

NCT05805267

Sponsor

Hunan Province Tumor Hospital

Status

Completed

Last Update Posted

Apr 7, 2023Actual

Enrollment

130Actual

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2022Actual

Primary Completion Date

Feb 25, 2023Actual

Completion Date

Mar 25, 2023Actual

First Submitted Date

Mar 27, 2023

First Submission Date that Met QC Criteria

Mar 27, 2023

First Posted Date

Apr 7, 2023Actual

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 27, 2023

Last Update Posted Date

Apr 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yongchang Zhang, Director, Head of Medical Oncology, Principal Investigator, Clinical Professor, Hunan Province Tumor HospitalPrincipal Investigator

Lead Sponsor

Hunan Province Tumor HospitalOTHER

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

Evaluated the correlation between the qualitative test results of Xiamen Aide the gene test specified by the test reagent and the efficacy of relevant targeted drugs in patients with non-small cell lung cancery, and the research data is used to support the registration and marketing of the assessment reagent

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

Retention

Enrollment

130Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS	Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)	2 year

Secondary Outcomes

Measure	Description	Time Frame
ORR	Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1)≥18;
2) advanced non-small cell lung cancer confirmed by histopathology;
3) Patients with NSCLC who have previously or are taking gefitinib (first-line therapy) or osimertinib (post-TKI resistance) or crizotinib monotherapy, and the response to treatment can be assessed;
4) Have sufficient FFPE tissue samples within 5 years: 5 large specimens/case; There were 10 puncture specimens/case

Exclusion Criteria:

1) Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs;
2)Maintenance therapy if the disease does not progress after treatment with other antitumor methods

Accepts Healthy Volunteers

Not provided

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 with non-small cell lung cancer who have previously received or are taking gefitinib (first-line therapy) or osimertinib (post-TKI resistance) or crizotinib monotherapy

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Hunan Cancer hospital		Changsha	Hunan		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