NCT05450081

Completed

Association Between the Results of Specific Genetic Tests an...

Hunan Province Tumor Hospital Source

Compare

Other study identifiers

Sponsor study identifier

ART

Study Type

observational

Actual enrollment (reported)

140

Locations

1 country

Sites

1

Timeline

Study Start

June 30, 2022

Actual (reported)

Primary Completion

March 31, 2023

Actual (reported)

Study Completion

October 1, 2023

Actual (reported)

Brief Summary

Our study aimed to evaluate the correlation between test reagent specific gene test results and the efficacy of relevant targeted drugs in patients with non-small cell lung cancer, and to support the continued registration of test reagents.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 140 participants
Study completion date: October 1, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 29, 2022
Actual (reported)
Study Start
June 30, 2022
Actual (reported)
First Posted
July 8, 2022
Actual (reported)
Primary Completion
March 31, 2023
Actual (reported)
Study Completion
October 1, 2023
Actual (reported)

Last Updated: December 27, 2023
Status Verified: December 2023
Last Update Submitted: December 25, 2023

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

PFS
Progression free survival time
October 2022-December 2022
ORR
Objective response rate
October 2022-December 2022
Consistency
he consistency of efficacy between specified kit and 22C3
October 2022-December 2022

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Patients with non-small cell lung cancer who have previously received single-agent K therapy

You may qualify if:

)≥18，advanced non-small cell lung cancer confirmed by histopathology, and were previously or currently treated with gefitinib tablets (as the first-line treatment) or osimertinib (first-generation TKI resistance treatment) or crizotinib capsules monotherapy were evaluated for efficacy.

Sponsors & Collaborators

Hunan Province Tumor Hospital
Otherlead

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, China

Biospecimen

Retention: SAMPLES WITH DNA

tissue sample and plasma DNA

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

Yongchang Zhang, MD
Hunan Cancer Hospital
PRINCIPAL INVESTIGATOR

Enrollment

140 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 8, 2022

Study Start

June 30, 2022

Actual (reported)

NCT05284539

Efficacy of Platinum-based Chemotherapy Plus Immune Checkpoint Inhibitors for EGFR/ALK/ROS1 Mutant Lung Cancer

Phase 2Recruiting

NCT05059951

Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer

Recruiting

NCT05379803

High-dose Furmonertinib for First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases

Phase 2Unknown

NCT05014464

ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma

Phase 2Recruiting

NCT04997382

Chemotherapy Combined with ICIs in First-line Alectinib Failed Patients with ALK-rearranged NSCLC

Phase 2Completed

NCT05129462

Consistency of PD-L1 Detecting Method Between E1L3N and 22C3 Monoclonal Antibodies in NSCLC Patients

Completed

\) Able to provide FFPE samples with a storage life of 5 years: Large specimen 5 pieces in each case; 10 puncture specimens in each case

You may not qualify if:

\) Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells \>20%);
\) Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs;
\) Maintenance treatment when the disease does not progress after other anti-tumor treatments.

Contact the study team to confirm eligibility.

Primary Completion

March 31, 2023

Actual (reported)

Study Completion

October 1, 2023

Actual (reported)

Last Updated

December 27, 2023

Record last verified: 2023-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05450081
Data provider: ClinicalTrials.gov
Source updated: 2023-12-27
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:42 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations