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NCT04745715 Clinical Trial

Genomic Study in Non-small Cell Lung Cancer Brain Metastasis

Brain Metastases Clinical Trial

Official title:
Genomic Analysis in Surgically Treated NSCLC Brain Metastasis Based on Neurosurgical Perspectives

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04745715
Other study ID # A-ER-109-437
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2011
Est. completion date October 31, 2022

Study information
Verified date December 2020
Source National Cheng-Kung University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators collected the data from the investigators' center between January 2011 and October 2020. The study included all non-small cell lung cancer patients with surgically excised brain metastasis. The investigators analysis the correlation of gene mutation and the disease course.

Description:

The investigators collected the data from from the investigators' center between January 2011 and October 2020. The study included all non-small cell lung cancer patients with surgically excised brain metastasis. The investigators analysis the correlation of gene mutation and the disease course. The investigators use Kaplan-Meier regression to analyze the overall survival, and the difference between the groups was calculated using log rank test. Cox proportional hazards method was used to create the regression model and estimate the hazard ratios.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date October 31, 2022
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients diagnosed with non-small cell lung cancer who underwent craniectomy and subsequent whole brain radiotherapy and associated chemo or target therapy Exclusion Criteria: - patient who did not receive postoperative adjuvant therapy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• craniectomy
craniectomy outcomes and survival

Locations
Country Name City State
Taiwan National Cheng Kung University hospital Tainan

Sponsors (1)
Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative survival From date of craniectomy until the date of patient deceased or date of last followed medical record, with median follow up around to 20 months
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