LymphomaSKETChNCT05865678
Musculoskeletal Health in Adult Haematological Cancer Survivors
An observational study of Lymphoma and Leukemia, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Haematological cancer treatment often includes use of high dose glucocorticoids (steroids), chemotherapy and radiotherapy and current evidence suggests that these patients may have lower bone mineral density after treatment when compared to the general population which can predispose them to increased risk of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphoma, Leukemia, Cancer Survivors
- What is being tested?
- Not an intervention study
- How many people
- 650 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 May 2023to May 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be identified from The Christie NHS Foundation Trust local haematology and lymphoma survivors' clinical patient databases. The haematology database used is the HSCT database that records all haematology patients that have undergo haematopoietic stem cell transplant. For lymphoma patients, the ADAPT (Managed Local Follow up of Long-Term Lymphoma Survivors) database will be used which records lymphoma patients that are cured and had 5 years regular hospital follow up post treatment.
Who may be able to join
- Age 18 or above at diagnosis of haematological cancer
- Diagnosis of haematological cancers: lymphoma or leukaemia
- Cancer survivors as recorded in the local database of lymphoma and haematopoietic stem cell transplant database
- Able to give written informed consent
- Able to read and understand English
- Age 18 or above at diagnosis of haematological cancer
Show all 10Show fewer
- Diagnosis of haematological cancers: lymphoma or leukaemia
- Cancer survivors as recorded in the local database of lymphoma and haematopoietic stem cell transplant database
- Able to give written or verbal informed consent
- Able to read and understand English
Who cannot join
- 1.Currently receiving any active cancer treatment
- Interview study
- 1 .Currently receiving any active cancer treatment
Trial locations and contacts
1 site in 1 country.
Claire Higham, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Salina Tsui, 07726781196, salina.tsui@nhs.net
About this study
Official title: Musculoskeletal Health in Adult Haematoloigcal Cancer Survivors - a Mixed Methods Study
Haematological cancer treatment often includes use of high dose glucocorticoids (steroids), chemotherapy and radiotherapy and current evidence suggests that these patients may have lower bone mineral density after treatment when compared to the general population which can predispose them to increased risk of fragility fractures. Evidence of the impact of these musculoskeletal burden to patients (e.g. quality of life) are not available.
This study aims to describe musculoskeletal complications experienced by long-term haematological cancer survivors and examine the impact of the burden from the patient perspective. The study will be conducted in 2 parts; a questionnaire study and an interview study to help understand the extent of musculoskeletal problems experienced by this group of patients and the impact of this on quality of life.
- Conditions
- Lymphoma, Leukemia, Cancer Survivors, Musculoskeletal Complication
- Being tested
- Not an intervention study
- Medical subject headings
- Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not an intervention studyOther
This is a study administering questionnaire and interviews using mixed quantitative and qualitative methodology with the aim to describe and evaluate musculoskeletal health of adult haematological cancer survivors and its impact to survivors.
| Study group | Role | What they receive |
|---|---|---|
| 5-10 years post cancer treatment; male; age at diagnosis 18-30 | Not described Receives: Other: Not an intervention study | |
| 5-10 years post cancer treatment; male; age at diagnosis 31-50 | Not described Receives: Other: Not an intervention study | |
| 5-10 years post cancer treatment; male; age at diagnosis 51-70 | Not described Receives: Other: Not an intervention study | |
| 5-10 years post cancer treatment; male; age at diagnosis 70+ | Not described Receives: Other: Not an intervention study | |
| 5-10 years post cancer treatment; female; age at diagnosis 18-30 | Not described Receives: Other: Not an intervention study | |
| 5-10 years post cancer treatment; female; age at diagnosis 31-50 | Not described Receives: Other: Not an intervention study | |
| 5-10 years post cancer treatment; female; age at diagnosis 51-70 | Not described Receives: Other: Not an intervention study | |
| 5-10 years post cancer treatment; female; age at diagnosis 70+ | Not described Receives: Other: Not an intervention study | |
| 11-20 years post cancer treatment; male; age at diagnosis 18-30 | Not described Receives: Other: Not an intervention study | |
| 11-20 years post cancer treatment; male; age at diagnosis 31-50 | Not described Receives: Other: Not an intervention study | |
| 11-20 years post cancer treatment; male; age at diagnosis 51-70 | Not described Receives: Other: Not an intervention study | |
| 11-20 years post cancer treatment; male; age at diagnosis 70+ | Not described Receives: Other: Not an intervention study | |
| 11-20 years post cancer treatment; female; age at diagnosis 18-30 | Not described Receives: Other: Not an intervention study | |
| 11-20 years post cancer treatment; female; age at diagnosis 31-50 | Not described Receives: Other: Not an intervention study | |
| 11-20 years post cancer treatment; female; age at diagnosis 51-70 | Not described Receives: Other: Not an intervention study | |
| 11-20 years post cancer treatment; female; age at diagnosis 70+ | Not described Receives: Other: Not an intervention study | |
| 21-30 years post cancer treatment; male; age at diagnosis 18-30 | Not described Receives: Other: Not an intervention study | |
| 21-30 years post cancer treatment; male; age at diagnosis 31-50 | Not described Receives: Other: Not an intervention study | |
| 21-30 years post cancer treatment; male; age at diagnosis 51-70 | Not described Receives: Other: Not an intervention study | |
| 21-30 years post cancer treatment; male; age at diagnosis 70+ | Not described Receives: Other: Not an intervention study | |
| 21-30 years post cancer treatment; female; age at diagnosis 18-30 | Not described Receives: Other: Not an intervention study | |
| 21-30 years post cancer treatment; female; age at diagnosis 31-50 | Not described Receives: Other: Not an intervention study | |
| 21-30 years post cancer treatment; female; age at diagnosis 51-70 | Not described Receives: Other: Not an intervention study | |
| 21-30 years post cancer treatment; female; age at diagnosis 70+ | Not described Receives: Other: Not an intervention study | |
| 30 years + post cancer treatment; male; age at diagnosis 18-30 | Not described Receives: Other: Not an intervention study | |
| 30 years + post cancer treatment; male; age at diagnosis 31-50 | Not described Receives: Other: Not an intervention study | |
| 30 years + post cancer treatment; male; age at diagnosis 51-70 | Not described Receives: Other: Not an intervention study | |
| 30 years + post cancer treatment; male; age at diagnosis 70+ | Not described Receives: Other: Not an intervention study | |
| 30 years + post cancer treatment; female; age at diagnosis 18-30 | Not described Receives: Other: Not an intervention study | |
| 30 years + post cancer treatment; female; age at diagnosis 31-50 | Not described Receives: Other: Not an intervention study | |
| 30 years + post cancer treatment; female; age at diagnosis 51-70 | Not described Receives: Other: Not an intervention study | |
| 30 years + post cancer treatment; female; age at diagnosis 70+ | Not described Receives: Other: Not an intervention study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionniare study: To measure prevalence of musculoskeletal conditions and related symptoms experienced by adult lymphoma and leukaemia survivors
Musculoskeletal conditions and related symptoms will be recorded by patients on the study specific questionnaire and the validated questionnaire Nordic musculoskeletal questionnaire (NMQ-E) and gait, arms, legs and spine (GALS) assessment
Measured: overall length of the study - 6 months
Questionniare study: To calculate the 10-year probability of hip fracture and major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture) of adult lymphoma and leukaemia survivors
The 10-year probability of hip fracture and major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture) of adult lymphoma and leukaemia survivors will be calculated using the Fracture Risk Assessment Tool (FRAX) and Q-Fracture calculator.
Measured: overall length of the study - 6 months
Questionniare study: To measure prevalence of sarcopenia and frailty among adult lymphoma and leukaemia survivors
Validated questionniares will be used to assess if patients have sarcopenia (SARC-F questionnaire) and frailty (FiND questionnaire).
Measured: overall length of the study - 6 months
Questionniare study: To assess quality of life and musculoskeletal function related quality of life of adult lymphoma and leukaemia survivors
This will be assessed using validated questionnaires - Short Form Survey (SF36) and Short Musculoskeletal Function Assessment (SMFA).
Measured: overall length of the study - 6 months
Interivew study: To describe experience of adult lymphoma and leukaemia survivors on musculoskeletal health, musculoskeletal related care and musculoskeletal health information provision.
Semi-structured qualitative interviews will be conducted with a topic guide to ensure same broad topics are explored in the interviews on musculoskeletal health experience, care and information provision.
Measured: overall length of the study - 6 months
Secondary outcomes (1)
Questionnaire study: To describe the likely risk factors that may be associated with musculoskeletal consequences of adult lymphoma and leukaemia survivors Impact of musculoskeletal health
This will be assessed using regression analysis to determine risk factors that may be associated with poor musculoskeletal health
Measured: overall length of the study - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start2 May 2023
- Primary completionMar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865678
- Sponsor's protocol ID
- CFTsp167
- Acronym
- SKETCh
- Status last verified
- Feb 2024
- First submitted
- 24 Apr 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Health in Adult Haematoloigcal Cancer Survivors - a Mixed Methods Study
- ClinicalTrials.gov ID
- NCT05865678
- Acronym / sponsor ID
- SKETCh / CFTsp167
- Conditions
- Lymphoma, Leukemia, Cancer Survivors, Musculoskeletal Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 2 May 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 19 May 2023 (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.
Haematological cancer treatment often includes use of high dose glucocorticoids (steroids), chemotherapy and radiotherapy and current evidence suggests that these patients may have lower bone mineral density after treatment when compared to the general population which can predispose them to increased risk of fragility fractures. Evidence of the impact of these musculoskeletal burden to patients (e.g. quality of life) are not available.
This study aims to describe musculoskeletal complications experienced by long-term haematological cancer survivors and examine the impact of the burden from the patient perspective. The study will be conducted in 2 parts; a questionnaire study and an interview study to help understand the extent of musculoskeletal problems experienced by this group of patients and the impact of this on quality of life.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 32
| Arm | Type | Receives |
|---|---|---|
| 5-10 years post cancer treatment; male; age at diagnosis 18-30 | – | Other: Not an intervention study |
| 5-10 years post cancer treatment; male; age at diagnosis 31-50 | – | Other: Not an intervention study |
| 5-10 years post cancer treatment; male; age at diagnosis 51-70 | – | Other: Not an intervention study |
| 5-10 years post cancer treatment; male; age at diagnosis 70+ | – | Other: Not an intervention study |
| 5-10 years post cancer treatment; female; age at diagnosis 18-30 | – | Other: Not an intervention study |
| 5-10 years post cancer treatment; female; age at diagnosis 31-50 | – | Other: Not an intervention study |
| 5-10 years post cancer treatment; female; age at diagnosis 51-70 | – | Other: Not an intervention study |
| 5-10 years post cancer treatment; female; age at diagnosis 70+ | – | Other: Not an intervention study |
| 11-20 years post cancer treatment; male; age at diagnosis 18-30 | – | Other: Not an intervention study |
| 11-20 years post cancer treatment; male; age at diagnosis 31-50 | – | Other: Not an intervention study |
| 11-20 years post cancer treatment; male; age at diagnosis 51-70 | – | Other: Not an intervention study |
| 11-20 years post cancer treatment; male; age at diagnosis 70+ | – | Other: Not an intervention study |
| 11-20 years post cancer treatment; female; age at diagnosis 18-30 | – | Other: Not an intervention study |
| 11-20 years post cancer treatment; female; age at diagnosis 31-50 | – | Other: Not an intervention study |
| 11-20 years post cancer treatment; female; age at diagnosis 51-70 | – | Other: Not an intervention study |
| 11-20 years post cancer treatment; female; age at diagnosis 70+ | – | Other: Not an intervention study |
| 21-30 years post cancer treatment; male; age at diagnosis 18-30 | – | Other: Not an intervention study |
| 21-30 years post cancer treatment; male; age at diagnosis 31-50 | – | Other: Not an intervention study |
| 21-30 years post cancer treatment; male; age at diagnosis 51-70 | – | Other: Not an intervention study |
| 21-30 years post cancer treatment; male; age at diagnosis 70+ | – | Other: Not an intervention study |
| 21-30 years post cancer treatment; female; age at diagnosis 18-30 | – | Other: Not an intervention study |
| 21-30 years post cancer treatment; female; age at diagnosis 31-50 | – | Other: Not an intervention study |
| 21-30 years post cancer treatment; female; age at diagnosis 51-70 | – | Other: Not an intervention study |
| 21-30 years post cancer treatment; female; age at diagnosis 70+ | – | Other: Not an intervention study |
| 30 years + post cancer treatment; male; age at diagnosis 18-30 | – | Other: Not an intervention study |
| 30 years + post cancer treatment; male; age at diagnosis 31-50 | – | Other: Not an intervention study |
| 30 years + post cancer treatment; male; age at diagnosis 51-70 | – | Other: Not an intervention study |
| 30 years + post cancer treatment; male; age at diagnosis 70+ | – | Other: Not an intervention study |
| 30 years + post cancer treatment; female; age at diagnosis 18-30 | – | Other: Not an intervention study |
| 30 years + post cancer treatment; female; age at diagnosis 31-50 | – | Other: Not an intervention study |
| 30 years + post cancer treatment; female; age at diagnosis 51-70 | – | Other: Not an intervention study |
| 30 years + post cancer treatment; female; age at diagnosis 70+ | – | Other: Not an intervention study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be identified from The Christie NHS Foundation Trust local haematology and lymphoma survivors' clinical patient databases. The haematology database used is the HSCT database that records all haematology patients that have undergo haematopoietic stem cell transplant. For lymphoma patients, the ADAPT (Managed Local Follow up of Long-Term Lymphoma Survivors) database will be used which records lymphoma patients that are cured and had 5 years regular hospital follow up post treatment.
Key inclusion criteria (10 listed)
- Age 18 or above at diagnosis of haematological cancer
- Diagnosis of haematological cancers: lymphoma or leukaemia
- Cancer survivors as recorded in the local database of lymphoma and haematopoietic stem cell transplant database
- Able to give written informed consent
- Able to read and understand English
Key exclusion criteria (3 listed)
- 1.Currently receiving any active cancer treatment
- Interview study
- 1 .Currently receiving any active cancer treatment
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 |
|---|---|---|
| Not an intervention studyThis is a study administering questionnaire and interviews using mixed quantitative and qualitative methodology with the aim to describe and evaluate musculoskeletal health of adult haematological cancer survivors and its impact to survivors. | Other | 11-20 years post cancer treatment; female; age at diagnosis 18-30, 11-20 years post cancer treatment; female; age at diagnosis 31-50, 11-20 years post cancer treatment; female; age at diagnosis 51-70, 11-20 years post cancer treatment; female; age at diagnosis 70+, 11-20 years post cancer treatment; male; age at diagnosis 18-30, 11-20 years post cancer treatment; male; age at diagnosis 31-50, 11-20 years post cancer treatment; male; age at diagnosis 51-70, 11-20 years post cancer treatment; male; age at diagnosis 70+, 21-30 years post cancer treatment; female; age at diagnosis 18-30, 21-30 years post cancer treatment; female; age at diagnosis 31-50, 21-30 years post cancer treatment; female; age at diagnosis 51-70, 21-30 years post cancer treatment; female; age at diagnosis 70+, 21-30 years post cancer treatment; male; age at diagnosis 18-30, 21-30 years post cancer treatment; male; age at diagnosis 31-50, 21-30 years post cancer treatment; male; age at diagnosis 51-70, 21-30 years post cancer treatment; male; age at diagnosis 70+, 30 years + post cancer treatment; female; age at diagnosis 18-30, 30 years + post cancer treatment; female; age at diagnosis 31-50, 30 years + post cancer treatment; female; age at diagnosis 51-70, 30 years + post cancer treatment; female; age at diagnosis 70+, 30 years + post cancer treatment; male; age at diagnosis 18-30, 30 years + post cancer treatment; male; age at diagnosis 31-50, 30 years + post cancer treatment; male; age at diagnosis 51-70, 30 years + post cancer treatment; male; age at diagnosis 70+, 5-10 years post cancer treatment; female; age at diagnosis 18-30, 5-10 years post cancer treatment; female; age at diagnosis 31-50, 5-10 years post cancer treatment; female; age at diagnosis 51-70, 5-10 years post cancer treatment; female; age at diagnosis 70+, 5-10 years post cancer treatment; male; age at diagnosis 18-30, 5-10 years post cancer treatment; male; age at diagnosis 31-50, 5-10 years post cancer treatment; male; age at diagnosis 51-70, 5-10 years post cancer treatment; male; age at diagnosis 70+ |
Primary outcome
Questionniare study: To measure prevalence of musculoskeletal conditions and related symptoms experienced by adult lymphoma and leukaemia survivors
Time frame: overall length of the study - 6 months
Musculoskeletal conditions and related symptoms will be recorded by patients on the study specific questionnaire and the validated questionnaire Nordic musculoskeletal questionnaire (NMQ-E) and gait, arms, legs and spine (GALS) assessment
Questionniare study: To calculate the 10-year probability of hip fracture and major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture) of adult lymphoma and leukaemia survivors
Time frame: overall length of the study - 6 months
The 10-year probability of hip fracture and major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture) of adult lymphoma and leukaemia survivors will be calculated using the Fracture Risk Assessment Tool (FRAX) and Q-Fracture calculator.
Questionniare study: To measure prevalence of sarcopenia and frailty among adult lymphoma and leukaemia survivors
Time frame: overall length of the study - 6 months
Validated questionniares will be used to assess if patients have sarcopenia (SARC-F questionnaire) and frailty (FiND questionnaire).
Questionniare study: To assess quality of life and musculoskeletal function related quality of life of adult lymphoma and leukaemia survivors
Time frame: overall length of the study - 6 months
This will be assessed using validated questionnaires - Short Form Survey (SF36) and Short Musculoskeletal Function Assessment (SMFA).
Interivew study: To describe experience of adult lymphoma and leukaemia survivors on musculoskeletal health, musculoskeletal related care and musculoskeletal health information provision.
Time frame: overall length of the study - 6 months
Semi-structured qualitative interviews will be conducted with a topic guide to ensure same broad topics are explored in the interviews on musculoskeletal health experience, care and information provision.
1 secondary outcome
Questionnaire study: To describe the likely risk factors that may be associated with musculoskeletal consequences of adult lymphoma and leukaemia survivors Impact of musculoskeletal health
Time frame: overall length of the study - 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
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.
Claire Higham, PhD contact
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 Lymphoma and Leukemia, run by The Christie 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 10 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salina Tsui, MSc (+44 7726781196, salina.tsui@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionniare study: To measure prevalence of musculoskeletal conditions and related symptoms experienced by adult lymphoma and leukaemia survivors (time frame: overall length of the study - 6 months). The study lists 5 primary outcomes in all. 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 21 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.