Spinal MetastasesNCT04110457
Outcomes of Surgical Treatment of Patients With Spinal Metastasis in AUH
An observational study of Spinal Metastases, run by Assiut University at 1 site in Egypt.
Trial summary
To analyze the outcomes of surgical treatment of patients with spinal metastases in spine unit in AUH regarding the pain control, neurological status and ambulatory status as well as survival rate . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- spinal decompression
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 30 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with spinal metastases
Who may be able to join
- Patients > 18 years old
- Patient with tissue proven dx of cancer
Who cannot join
- Patient younger 18 years old
- CNS or spinal 1ry tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Surgical Treatment of Patients With Spinal Metastasis in Assiut University Hospitals
To analyze the outcomes of surgical treatment of patients with spinal metastases in spine unit in AUH regarding the pain control, neurological status and ambulatory status as well as survival rate .
Read the detailed description
this study monitor what is the results after operative treatment of patients which have secondary metastases in spinal column concerning quality of live for one year and pain and neurology
- Conditions
- Spinal Metastases
- Being tested
- spinal decompression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal decompressionProcedure or surgery
spinal surgery by decompression or fixation
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate quality of life after surgery
to evaluate the general condition using 5Q-ED score
Measured: baseline
Secondary outcomes (1)
to analyze postoperative pain control , stability and ambulatory statues after surgical treatment of spinal metastases.
evaluation of postoperative pain and neurology and comparing with preoperative data
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Apr 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2022
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 Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim gamal asem, Assiut University
- Investigators
- Essam El morshidy, PHD, Study director, lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110457
- Sponsor's protocol ID
- surgical treatment in spine
- Status last verified
- Dec 2022
- First submitted
- 27 Sep 2019
- Last updated
- 28 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hirabayashi H, Ebara S, Kinoshita T, Yuzawa Y, Nakamura I, Takahashi J, Kamimura M, Ohtsuka K, Takaoka K. Clinical outcome and survival after palliative surgery for spinal metastases: palliative surgery in spinal metastases. Cancer. 2003 Jan 15;97(2):476-84. doi: 10.1002/cncr.11039.
PubMed 12518372Maccauro G, Spinelli MS, Mauro S, Perisano C, Graci C, Rosa MA. Physiopathology of spine metastasis. Int J Surg Oncol. 2011;2011:107969. doi: 10.1155/2011/107969. Epub 2011 Aug 10.
PubMed 22312491
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Surgical Treatment of Patients With Spinal Metastasis in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT04110457
- Acronym / sponsor ID
- surgical treatment in spine
- Conditions
- Spinal Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 1 Oct 2019 (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.
To analyze the outcomes of surgical treatment of patients with spinal metastases in spine unit in AUH regarding the pain control, neurological status and ambulatory status as well as survival rate .
Detailed description
this study monitor what is the results after operative treatment of patients which have secondary metastases in spinal column concerning quality of live for one year and pain and neurology
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with spinal metastases
Key inclusion criteria (2 listed)
- Patients > 18 years old
- Patient with tissue proven dx of cancer
Key exclusion criteria (2 listed)
- Patient younger 18 years old
- CNS or spinal 1ry tumor
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 |
|---|---|---|
| spinal decompressionspinal surgery by decompression or fixation | Procedure or surgery | – |
Primary outcome
Evaluate quality of life after surgery
Time frame: baseline
to evaluate the general condition using 5Q-ED score
1 secondary outcome
to analyze postoperative pain control , stability and ambulatory statues after surgical treatment of spinal metastases.
Time frame: Baseline
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 28 Dec 2022.
- Background: PubMed 12518372Hirabayashi H, Ebara S, Kinoshita T, Yuzawa Y, Nakamura I, Takahashi J, Kamimura M, Ohtsuka K, Takaoka K. Clinical outcome and survival after palliative surgery for spinal metastases: palliative surgery in spinal metastases. Cancer. 2003 Jan 15;97(2):476-84. doi: 10.1002/cncr.11039.
- Results publication: PubMed 22312491Maccauro G, Spinelli MS, Mauro S, Perisano C, Graci C, Rosa MA. Physiopathology of spine metastasis. Int J Surg Oncol. 2011;2011:107969. doi: 10.1155/2011/107969. Epub 2011 Aug 10.
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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.
Essam El morshidy, PHD study director
lecturer
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 Spinal Metastases, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 2 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 28 Dec 2022. 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 Egypt. 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?
Evaluate quality of life after surgery (time frame: baseline). 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 NCT04110457, 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 28 Dec 2022.