Neoplasm MetastasisNCT02934594
Metastatic Spinal Cord Compression (MSCC): Treatment Timing and Survival Rate
An observational study of Neoplasm Metastasis and Spinal Cord Compression, run by National Taiwan University Hospital.
Trial summary
Patients with metastatic spinal cord compression (MSCC) are treated with different options according to the life expectancy. Survival and surgical outcome can be influenced by surgical timing in MSCC patients treated with palliative decompression. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Neoplasm Metastasis, Spinal Cord Compression
- What is being tested?
- Palliative Decompression
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Aug 2020
- How long will I take part?
- 2 Years
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression.
Who may be able to join
- Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression in National Taiwan University Hospital after January 1st, 2012.
Who cannot join
- Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression before December 31st, 2011, or those who were not treated in National Taiwan University Hospital.
Trial locations and contacts
No sites are listed yet.
About this study
Patients with metastatic spinal cord compression (MSCC) are treated with different options according to the life expectancy. Survival and surgical outcome can be influenced by surgical timing in MSCC patients treated with palliative decompression.
Read the detailed description
MSCC patients who underwent palliative decompression after January 2012 in National Taiwan University Hospital (NTUH) were divided into the preoperative motor function intact group (Group A) and motor deficit group (Group B). The motor deficit group was subdivided into operation within 48 hours (Group B1), and after 48 hours (Group B2). All patients underwent palliative decompression and posterior stabilization. Investigators did wide laminectomy for tumor invading the vertebral body, and debulking surgery for tumor destructing the posterior column of the spine. Investigators retrospectively reviewed all patient records, including patient demographics, prognostic factors for survival (Kaplan-Meier survival analysis), neurological outcome (Frankel grade), primary tumor, complications, and relevance of Tomita and Tokuhashi scores.
- Conditions
- Neoplasm Metastasis, Spinal Cord Compression
- Being tested
- Palliative Decompression
- Medical subject headings
- Neoplasm Metastasis, Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative DecompressionOther
palliative decompression to MSCC patients: before motor deficit (Group A), within 48 hours after motor deficit (Group B1), 48 hours after motor deficit (Group B2)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Motor function intact group: received palliative decompression Receives: Other: Palliative Decompression | |
| Group B1 | motor deficit group: received palliative decompression within 48 hours after symptoms occured Receives: Other: Palliative Decompression | |
| Group B2 | motor deficit group: received palliative decompression 48 hours after symptoms occured Receives: Other: Palliative Decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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 only
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Hua Yang, M.D., Ph.D., Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934594
- Sponsor's protocol ID
- 201608007RIND
- Status last verified
- Oct 2016
- First submitted
- 11 Oct 2016
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tokuhashi Y, Matsuzaki H, Oda H, Oshima M, Ryu J. A revised scoring system for preoperative evaluation of metastatic spine tumor prognosis. Spine (Phila Pa 1976). 2005 Oct 1;30(19):2186-91. doi: 10.1097/01.brs.0000180401.06919.a5.
PubMed 16205345Tomita K, Kawahara N, Kobayashi T, Yoshida A, Murakami H, Akamaru T. Surgical strategy for spinal metastases. Spine (Phila Pa 1976). 2001 Feb 1;26(3):298-306. doi: 10.1097/00007632-200102010-00016.
PubMed 11224867
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metastatic Spinal Cord Compression (MSCC): Treatment Timing and Survival Rate
- ClinicalTrials.gov ID
- NCT02934594
- Acronym / sponsor ID
- 201608007RIND
- Conditions
- Neoplasm Metastasis, Spinal Cord Compression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 17 Oct 2016 (estimated)
- 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.
Patients with metastatic spinal cord compression (MSCC) are treated with different options according to the life expectancy. Survival and surgical outcome can be influenced by surgical timing in MSCC patients treated with palliative decompression.
Detailed description
MSCC patients who underwent palliative decompression after January 2012 in National Taiwan University Hospital (NTUH) were divided into the preoperative motor function intact group (Group A) and motor deficit group (Group B). The motor deficit group was subdivided into operation within 48 hours (Group B1), and after 48 hours (Group B2). All patients underwent palliative decompression and posterior stabilization. Investigators did wide laminectomy for tumor invading the vertebral body, and debulking surgery for tumor destructing the posterior column of the spine. Investigators retrospectively reviewed all patient records, including patient demographics, prognostic factors for survival (Kaplan-Meier survival analysis), neurological outcome (Frankel grade), primary tumor, complications, and relevance of Tomita and Tokuhashi scores.
Study design
- Observational model
- Case only
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Palliative DecompressionMotor function intact group: received palliative decompression |
| Group B1 | – | Other: Palliative Decompressionmotor deficit group: received palliative decompression within 48 hours after symptoms occured |
| Group B2 | – | Other: Palliative Decompressionmotor deficit group: received palliative decompression 48 hours after symptoms occured |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression.
Key inclusion criteria (1 listed)
- Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression in National Taiwan University Hospital after January 1st, 2012.
Key exclusion criteria (1 listed)
- Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression before December 31st, 2011, or those who were not treated in National Taiwan University Hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative Decompressionpalliative decompression to MSCC patients: before motor deficit (Group A), within 48 hours after motor deficit (Group B1), 48 hours after motor deficit (Group B2) | Other | Group A, Group B1, Group B2 |
Primary outcome
survival rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Background: PubMed 16205345Tokuhashi Y, Matsuzaki H, Oda H, Oshima M, Ryu J. A revised scoring system for preoperative evaluation of metastatic spine tumor prognosis. Spine (Phila Pa 1976). 2005 Oct 1;30(19):2186-91. doi: 10.1097/01.brs.0000180401.06919.a5.
- Background: PubMed 11224867Tomita K, Kawahara N, Kobayashi T, Yoshida A, Murakami H, Akamaru T. Surgical strategy for spinal metastases. Spine (Phila Pa 1976). 2001 Feb 1;26(3):298-306. doi: 10.1097/00007632-200102010-00016.
- Individual participant dataSharing planned: No
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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.
Shu-Hua Yang, M.D., Ph.D. study chair
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasm Metastasis and Spinal Cord Compression, run by National Taiwan University Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Hua Yang, M.D., Ph.D. (886-2-23123456 ext. 63981, 005964@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02934594, which also lists 2 linked publications.
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 17 Oct 2016.