NCT07100444

Brief Summary

The aim of this study is to compare the clinical features and postoperative survival outcomes between patients with spinal metastasis as the initial manifestation of malignancy and those with spinal metastasis occurring after an established diagnosis of malignancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 3, 2025

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

7.2 years

First QC Date

July 24, 2025

Last Update Submit

July 27, 2025

Conditions

Keywords

lung cancersbone metastasisspinal metastasispostoperative survival outcomes

Outcome Measures

Primary Outcomes (1)

  • Postoperative Overall Survival

    Postoperative overall survival is defined as the time from the date of surgery for spinal metastasis to the date of death from any cause. Patients who are still alive at the last follow-up will be censored at that date. Survival status will be ascertained by clinical follow-up and/or review of medical records.

    From the date of surgery until death or last follow-up, up to 5 years

Study Arms (2)

Spinal Metastasis as the First Presentation of Lung Malignancy

It refers to patients who first present with symptoms such as pain or spinal cord compression caused by spinal metastasis, leading to the initial detection of bone metastasis, and are subsequently diagnosed with lung cancer.

lung cancer who subsequently developed spinal metastasis

It refers to patients with a history of treatment for primary lung cancer who subsequently developed spinal metastasis during the course of the disease.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adult patients diagnosed with lung cancer who have developed spinal metastasis. Participants will be selected from individuals treated at Guangdong Provincial People's Hospital. Eligible patients must have a diagnosis of lung cancer with spinal metastasis confirmed by pathological examination or imaging studies, and must have undergone surgical intervention for spinal metastasis.

You may qualify if:

  • Age ≥ 18 years.
  • Pathologically or radiologically confirmed diagnosis of lung cancer with spinal metastasis.
  • Patients with spinal metastasis who underwent surgical intervention.
  • Adequate medical records and follow-up data available.

You may not qualify if:

  • Patients with spinal metastasis originating from non-lung primary tumors.
  • Patients who did not receive surgical treatment for spinal metastasis.
  • Incomplete clinical data or lost to follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2025

First Posted

August 3, 2025

Study Start

January 1, 2018

Primary Completion

March 30, 2025

Study Completion

April 30, 2025

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because of patient privacy concerns and local data protection regulations. Data may contain sensitive personal information that cannot be sufficiently anonymized to ensure participant confidentiality.

Locations