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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06318065
Other study ID # B-ER111-370
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date September 1, 2024

Study information

Verified date February 2024
Source National Cheng-Kung University Hospital
Contact Jung-Shun Lee, M.D.
Phone 886-6-2353535
Email nslee1218@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

While many studies have investigated the prognostic factors for patients undergoing surgical resection for primary brain tumors, decision-making for patients with brain metastasis (BM) is more complex because of their higher burden of comorbidities compared to those with primary brain tumors. In addition, although various prognostic indicators have been identified to predict prognosis in several types of cancer, such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), prognostic nutritional index (PNI), and systemic immune-inflammation index (SII), limited studies have yet determined which group of patients would yield beater survival outcome after surgical resection for BM. This study aimed to investigate the impact of patient and perioperative characteristics and prognostic indicators on survival outcome of patients undergoing surgical resection of BM.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. patients with Clinical diagnosis of brain metastasis 2. patients who underwent craniotomy surgery for brain metastasis Exclusion Criteria: 1. patients with insufficient data for associated factors 2. patients who underwent stereotactic biopsy for brain metastasis 3. patients who did not undergo craniotomy surgery for brain metastasis

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Jung-Shun Lee Tainan None Selected

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 survival outcome of patients undergoing surgery for brain metastasis overall survival of patients From date of surgery until the date of death from any cause, whichever came first, assessed up to 100 months
Primary Functional outcome of patients undergoing surgery for brain metastasis change of preoperative and postoperative modified rankin scale from date of surgery until 6 months after surgery ordate of death from any cause, whichever came first
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