NCT06318065

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
14.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

March 22, 2024

Status Verified

February 1, 2024

Enrollment Period

14.4 years

First QC Date

February 25, 2024

Last Update Submit

March 20, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients newly diagnosed with BM due to various primary cancers who underwent surgery at our institution

You may qualify if:

  • patients with Clinical diagnosis of brain metastasis
  • patients who underwent craniotomy surgery for brain metastasis

You may not qualify if:

  • patients with insufficient data for associated factors
  • patients who underwent stereotactic biopsy for brain metastasis
  • patients who did not undergo craniotomy surgery for brain metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jung-Shun Lee

Tainan, None Selected, 70403, Taiwan

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jung-Shun Lee, M.D.

    National Cheng Kung Univsersity Hospital

    STUDY CHAIR

Central Study Contacts

Jung-Shun Lee, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2024

First Posted

March 19, 2024

Study Start

January 1, 2010

Primary Completion

June 1, 2024

Study Completion

September 1, 2024

Last Updated

March 22, 2024

Record last verified: 2024-02

Locations