Genomic Study in Non-small Cell Lung Cancer Brain Metastasis

• Sponsor: National Cheng-Kung University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04745715
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Anticipated Duration (Months): 130
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
NSCLC Stage IV; Brain Metastases	Procedure: craniectomy

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 90 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Genomic Analysis in Surgically Treated NSCLC Brain Metastasis Based on Neurosurgical Perspectives
• Actual Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Oct 31, 2020
• Anticipated Study Completion Date: Oct 31, 2021

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cheng Kung University hospital	Tainan		Taiwan

Sponsors and Collaborators

• National Cheng-Kung University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cheng-Kung University Hospital
• ClinicalTrials.gov Identifier: NCT04745715
• Other Study ID Numbers: A-ER-109-437
• First Posted: Feb 9, 2021
• Last Update Posted: Feb 9, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasm Metastasis; Brain Neoplasms

Study Results

No Results Posted as of Feb 9, 2021