Spinal TumorsPRO-SSITNCT07849868
Long-Term Patient Reported Outcomes Following Surgery for Spinal Intradural Tumours
An observational study of Spinal Tumors, run by Walton Centre NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The objective of this study is to identify the long-term impact of PSIDT tumours and their treatment on patient HRQoL for those managed at the Walton Centre NHS Foundation Trust (WCFT), which provides tertiary care to a catchment population of 3.5 million so will manage many patients with these rare tumours. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Tumors
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2024to 18 May 2026
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent surgery for an intradural spinal tumour between 2011 and 2018 inclusive, and fulfil the inclusion and exclusion criteria
Who may be able to join
- Patients who received surgery at the WCFT for a PSIDT, both intramedullary and extramedullary covering the time period 2011 to 2018
- Patients aged ≥16 years at the time of surgery for a PSIDT
- Able to communicate effectively using the English language
- Capacity to complete the study consent form
Who cannot join
- Patients aged <16 years at the time of surgery for a PSIDT
- Patients with metastatic spinal intradural tumours
- Patients with a previous spinal operation for a non-intradural tumour related indication
- Patients with a primary operation for a PSIDT before 2011
- Patients with any other congenital or acquired neurological disorder prior to diagnosis of SIDT
- Patients considered to lack capacity to consent to participate in this study (e.g. due to a significant neurological deficit or cognitive disorder)
- Patients with >1 tumour as part of a syndrome (e.g. neurofibromatosis or Von Hippel Lindau)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Walton Centre NHS Foundation Trust
Liverpool, Merseyside, L109LY
About this study
Official title: Long-term Patient Reported Outcomes Following Surgery for Spinal Intradural Tumours: A Cross-sectional Cohort Study
The objective of this study is to identify the long-term impact of PSIDT tumours and their treatment on patient HRQoL for those managed at the Walton Centre NHS Foundation Trust (WCFT), which provides tertiary care to a catchment population of 3.5 million so will manage many patients with these rare tumours. Additionally, the availability of Spine-Tango allows the identification of patients spanning a long duration of follow up. By encompassing a broad anatomical subset, we hope that this will be more sensitive to factors influencing PROs. Additionally, we aim to capture trends that may be more meaningful to patients by performing this long-term follow up. No studies have so far attempted to assess longer term patient reported HRQoL outcomes in this patient group. This study will better identify patient priorities, guide future research directions and holistic care planning. This will be achieved through a cross-sectional cohort study, which will evaluate PROs using five validated questionnaires at a single time point following surgery. These PRO measures will assess HRQoL. The definition of PRO includes the use of subjective measures such as those used for assessment of HRQoL
Read the detailed description
Although Intradural Extramedullary and Intradural Intramedullary tumours can have varied prognoses depending on the surgical features of the tumour and the histological subtype and grade, the range of possible neurological outcomes following surgery is a wide-ranging commonality. The short-term clinical outcomes for these tumours are well studied and generally understood to be favourable, particularly for Intradural Extramedullary tumours. Several studies have identified multiple factors that influence post-operative surgical outcomes, including pre-operative neurological grade, upper thoracic location and longitudinal extension of the tumour.
While longer-term studies assessing the surgical and neurological outcomes following treatment for PSIDT exist, the long-term impact on patient reported HRQoL is less well studied8. For example, one study by Seppala et al. retrospectively contacted 187 patients treated for spinal schwannoma with a median follow-up of 12.8 years. A non-validated symptom questionnaire was used to identify residual symptoms and long-term operative complications, but no patient reported HRQoL assessments were performed. In adults, one study by Xiao et al. did seek to assess HRQoL outcomes in 45 patients with Intradural Intramedullary tumours , although the duration of follow up was 22 months. This was performed using the EuroQol 5-Dimensions (EQ-5D), Pain disability questionnaire (PDQ) and Patient Health Questionnaire-9 (PHQ9).
The objective of this study is to identify the long-term impact of PSIDT tumours and their treatment on patient HRQoL for those managed at the Walton Centre NHS Foundation Trust (WCFT), which provides tertiary care to a catchment population of 3.5 million so will manage many patients with these rare tumours. Additionally, the availability of Spine-Tango allows the identification of patients spanning a long duration of follow up. By encompassing a broad anatomical subset, we hope that this will be more sensitive to factors influencing PROs. Additionally, we aim to capture trends that may be more meaningful to patients by performing this long-term follow up. No studies have so far attempted to assess longer term patient reported HRQoL outcomes in this patient group. This study will better identify patient priorities, guide future research directions and holistic care planning. This will be achieved through a cross-sectional cohort study, which will evaluate PROs using five validated questionnaires at a single time point following surgery. These PRO measures will assess HRQoL. The definition of PRO includes the use of subjective measures such as those used for assessment of HRQoL
- Conditions
- Spinal Tumors
- Keywords
- Spinal Intradural Tumors
- Medical subject headings
- Spinal Cord Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term patient-reported health-related quality of life (HRQoL)
All patients will receive a study-specific questionnaire booklet identifying:
- Active medical problems
- Current medications (and indications) as well as smoking status
- calculation of a Frankel Grade and level of deficit
- Current employment status
- Health-related quality of life questionnaires
This will allow for collection and analysis of long-term health related quality of life data
Measured: 3-10 years following completion of spinal intradural tumour surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start14 Mar 2024
- Primary completion27 Dec 2024
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal TumorsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walton Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nishaharan Srikandarajah, Principal investigator, Walton Centre NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849868
- Sponsor's protocol ID
- RG469-21
- Acronym
- PRO-SSIT
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Patient Reported Outcomes Following Surgery for Spinal Intradural Tumours: A Cross-sectional Cohort Study
- ClinicalTrials.gov ID
- NCT07849868
- Acronym / sponsor ID
- PRO-SSIT / RG469-21
- Conditions
- Spinal Tumors
- Keywords
- Spinal Intradural Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Walton Centre NHS Foundation TrustUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 30 Sep 2026 (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 objective of this study is to identify the long-term impact of PSIDT tumours and their treatment on patient HRQoL for those managed at the Walton Centre NHS Foundation Trust (WCFT), which provides tertiary care to a catchment population of 3.5 million so will manage many patients with these rare tumours. Additionally, the availability of Spine-Tango allows the identification of patients spanning a long duration of follow up. By encompassing a broad anatomical subset, we hope that this will be more sensitive to factors influencing PROs. Additionally, we aim to capture trends that may be more meaningful to patients by performing this long-term follow up. No studies have so far attempted to assess longer term patient reported HRQoL outcomes in this patient group. This study will better identify patient priorities, guide future research directions and holistic care planning. This will be achieved through a cross-sectional cohort study, which will evaluate PROs using five validated questionnaires at a single time point following surgery. These PRO measures will assess HRQoL. The definition of PRO includes the use of subjective measures such as those used for assessment of HRQoL
Detailed description
Although Intradural Extramedullary and Intradural Intramedullary tumours can have varied prognoses depending on the surgical features of the tumour and the histological subtype and grade, the range of possible neurological outcomes following surgery is a wide-ranging commonality. The short-term clinical outcomes for these tumours are well studied and generally understood to be favourable, particularly for Intradural Extramedullary tumours. Several studies have identified multiple factors that influence post-operative surgical outcomes, including pre-operative neurological grade, upper thoracic location and longitudinal extension of the tumour.
While longer-term studies assessing the surgical and neurological outcomes following treatment for PSIDT exist, the long-term impact on patient reported HRQoL is less well studied8. For example, one study by Seppala et al. retrospectively contacted 187 patients treated for spinal schwannoma with a median follow-up of 12.8 years. A non-validated symptom questionnaire was used to identify residual symptoms and long-term operative complications, but no patient reported HRQoL assessments were performed. In adults, one study by Xiao et al. did seek to assess HRQoL outcomes in 45 patients with Intradural Intramedullary tumours , although the duration of follow up was 22 months. This was performed using the EuroQol 5-Dimensions (EQ-5D), Pain disability questionnaire (PDQ) and Patient Health Questionnaire-9 (PHQ9).
The objective of this study is to identify the long-term impact of PSIDT tumours and their treatment on patient HRQoL for those managed at the Walton Centre NHS Foundation Trust (WCFT), which provides tertiary care to a catchment population of 3.5 million so will manage many patients with these rare tumours. Additionally, the availability of Spine-Tango allows the identification of patients spanning a long duration of follow up. By encompassing a broad anatomical subset, we hope that this will be more sensitive to factors influencing PROs. Additionally, we aim to capture trends that may be more meaningful to patients by performing this long-term follow up. No studies have so far attempted to assess longer term patient reported HRQoL outcomes in this patient group. This study will better identify patient priorities, guide future research directions and holistic care planning. This will be achieved through a cross-sectional cohort study, which will evaluate PROs using five validated questionnaires at a single time point following surgery. These PRO measures will assess HRQoL. The definition of PRO includes the use of subjective measures such as those used for assessment of HRQoL
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent surgery for an intradural spinal tumour between 2011 and 2018 inclusive, and fulfil the inclusion and exclusion criteria
Key inclusion criteria (4 listed)
- Patients who received surgery at the WCFT for a PSIDT, both intramedullary and extramedullary covering the time period 2011 to 2018
- Patients aged ≥16 years at the time of surgery for a PSIDT
- Able to communicate effectively using the English language
- Capacity to complete the study consent form
Key exclusion criteria (7 listed)
- Patients aged <16 years at the time of surgery for a PSIDT
- Patients with metastatic spinal intradural tumours
- Patients with a previous spinal operation for a non-intradural tumour related indication
- Patients with a primary operation for a PSIDT before 2011
- Patients with any other congenital or acquired neurological disorder prior to diagnosis of SIDT
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
Long-term patient-reported health-related quality of life (HRQoL)
Time frame: 3-10 years following completion of spinal intradural tumour surgery
All patients will receive a study-specific questionnaire booklet identifying: * Active medical problems * Current medications (and indications) as well as smoking status * calculation of a Frankel Grade and level of deficit * Current employment status * Health-related quality of life questionnaires This will allow for collection and analysis of long-term health related quality of life data
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 30 Sep 2026.
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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.
Nishaharan Srikandarajah principal investigator
Walton Centre NHS Foundation Trust
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 Tumors, run by Walton Centre NHS Foundation Trust at 1 site in United Kingdom.
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 7 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 30 Sep 2026. 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 United Kingdom. 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?
Long-term patient-reported health-related quality of life (HRQoL) (time frame: 3-10 years following completion of spinal intradural tumour surgery). 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 30 Sep 2026.