Lung CancersNCT07100444
Spinal Metastasis as the First Presentation of Lung Malignancy: Clinical Characteristics and Postoperative Survival
An observational study of Lung Cancers and Bone Metastasis, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancers, Bone Metastasis
- How many people
- 139 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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. By analyzing and contrasting these two groups, we seek to identify any distinctive characteristics, prognostic factors, and potential implications for early detection and treatment strategies in patients with malignant spinal metastases.
- Conditions
- Lung Cancers, Bone Metastasis
- Keywords
- lung cancers, bone metastasis, spinal metastasis, postoperative survival outcomes
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the date of surgery until death or last follow-up, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Jan 2018
- Primary completion30 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancersStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Zhang, PhD, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100444
- Sponsor's protocol ID
- lungfirstboneMetas
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Metastasis as the First Presentation of Lung Malignancy: Clinical Characteristics and Postoperative Survival
- ClinicalTrials.gov ID
- NCT07100444
- Acronym / sponsor ID
- lungfirstboneMetas
- Conditions
- Lung Cancers, Bone Metastasis
- Keywords
- lung cancers, bone metastasis, spinal metastasis, postoperative survival outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. By analyzing and contrasting these two groups, we seek to identify any distinctive characteristics, prognostic factors, and potential implications for early detection and treatment strategies in patients with malignant spinal metastases.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Overall Survival
Time frame: From the date of surgery until death or last follow-up, up to 5 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancers and Bone Metastasis, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Overall Survival (time frame: From the date of surgery until death or last follow-up, up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.