Leukemia, ChildhoodMyPal4KidsNCT04381221
Observational MyPal-Child Study on the ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients
An observational study of Leukemia, Childhood and Solid Tumor, Childhood, run by Centre for Research and Technology Hellas at 3 sites in 2 countries.
Trial summary
The main aim of the study is the evaluation of the feasibility of comprehensive service which has been developed while considering patient-orientated needs. With regard to the study, apps have been developed for both groups of participants, parents and their child which suffers from cancer. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Leukemia, Childhood, Solid Tumor, Childhood
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 22 Dec 2020to 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be recruited in each of the three participating clinical centers. Besides the children patients, an additional group of participants is constituted by the corresponding child's parents. At least one of the parents will be asked to participate in the study as well.
Who may be able to join
- 6-17 years of age
- Diagnosed with paediatric leukaemia or solid cancer in the past 12 months
- Receiving anti-cancer treatment at one of the participating clinical site
- Have age-appropriate speaking, reading and comprehension skills in either the German or the Czech language
- Provide signed + informed consent from parents or legal representative and the assent form by all children from the age of 14 years. These documents had been evaluated positively by IEC.
- Access to an internet connection and mobile device (e.g. smartphone or tablet)
Show all 10Show fewer
- Parent(s) with a child eligible for the study, as per the inclusion and exclusion-criteria
- Ability to speak, read and understand German or Czech language
- Provide signed informed consent by parent(s). These documents had been evaluated positively by IEC.
- Access to an internet connection and mobile device (e.g. smartphone or tablet)
Who cannot join
- Anyone who is not able to participate in the study according to the clinical judgment of the site chief investigator or any other authorized person of the research team. This judgment has to be documented for each child not being enrolled.
- Anyone who is not able to participate in the study according to the clinical judgment of the site chief investigator or any other authorized person of the research team. This judgment has to be documented for each parent not being enrolled.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites, 2 recruiting
- Recruiting
Medical School Hannover
Hanover, Lower Saxony, 30625
Annette Sander, MD, Sander.Annette@mh-hannover.de
Kasra Mirzaie, M.Sc., Mirzaie.Kasra@mh-hannover.de
- Recruiting
Saarland University
Homburg, Saarland, 66424
Norbert Graf, Professor MD, +49 68411628411, graf@uks.eu
Marcel Meyerheim, M.Sc., +49 68411628045, marcel.meyerheim@uks.eu
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Brno
Brno, Mähren, 62500
Petr Lokaj, MD, PLokaj@seznam.cz
Jana Didi, Magister, Didi.Jana@fnbrno.cz
About this study
Official title: Observational Prospective Clinical Feasibility Study of the MyPal ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients
The main aim of the study is the evaluation of the feasibility of comprehensive service which has been developed while considering patient-orientated needs. With regard to the study, apps have been developed for both groups of participants, parents and their child which suffers from cancer. These apps aim at supporting the documentation and communication of the own condition. This includes for example a video game which can be played via tablet or smartphone in which questions appear addressing the personally perceived burden by children amongst other things. Participants of the study are children between 6 and 17 years of age which suffer from leukemia or tumors. Further participants of the study are at least one of the patient's parents. It is an observational study. Within the course of the study, the usual treatment is not altered actively by the study, it is, however, supplemented by questionnaires which will be analyzed being anonymized after the end of the study running time.
Read the detailed description
The study is designed as observational prospective feasibility study. The main objective is to assess the feasibility of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems, which aim at supporting the communication between the patients, their parents and the treating medical healthcare professionals. Participants of the study are pediatric oncology patients between 6 and 17 years of age and at least one of their parents, receiving treatment at one of the participating clinical centers due to leukemia or solid tumors. With regard to the study, apps have been developed for both groups of participants, which includes inter alia a game in which questions about burden considering symptoms can be answered by the children.
- Conditions
- Leukemia, Childhood, Solid Tumor, Childhood
- Keywords
- Patient-Reported Outcome (PRO), electronic Patient-Reported Outcome (ePRO), Patient-Reported Outcome Measure (PROM), Palliative Care for Children, Supportive Care for Children, Serious Game, eHealth, Mobile Applications, Observative Study
- Medical subject headings
- Leukemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate, defined as percentage of patients eligible for the study from all patients who were screened for the study.
This contributes to the primary study objective: to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care and pediatric oncology by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
Measured: Regularly each month in the course of 6-month course of study enrollment.
Participation rate, defined as percentage of recruited patients who completed at least 70% of the scheduled questionnaires for 6 months out of all patients eligible for the study
This contributes to the primary study objective: to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
Measured: Regularly each month in the course of 6-month course of study enrollment
Adherence rate to the different components of the MyPal services by documentation of user behavior and qualitative analysis
This contributes to the primary study objective: to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
Measured: Regularly each month in the course of 6-month course of study enrollment
Premature discontinuation rate, defined as percentage of recruited patients who have not been followed-up until the end of 6-month course of study enrollment (withdrawal, death or less than 70% completed questionnaires)
This contributes to the primary study objective: to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
Measured: Regularly each month in the course of 6-month course of study enrollment
System Usability Scale
Min Value: 0, Max Value: 100, higher scores indicate a better outcome. Quantitative data to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
Measured: At the end of the 6-month course of study enrollment
Structured Interviews and Focus Groups
Qualitative data to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
Measured: At the end of the 6-month course of study enrollment
Secondary outcomes (6)
Digital adaption of the Mini-SSpedi / SSPedi questionnaires as ePRO.
Min Value: 0, Max Value: 5, higher scores indicate a worse outcome. To assess children's symptom burden through an in-game ePRO and optionally as standalone ePRO which can be completed outside the serious game.Further, this contributes to the evidence-base of the effectiveness of ePROs in palliative and supportive care for children with cancer.
Measured: Once at baseline and several times a week during the 6-month course of study enrollment. The frequency of single questions depends on severity of reported symptom burden.
PedsQL(TM) Cancer Module questionnaire as ePRO.
Min Value: 0, Max Value: 100, higher scores indicate a better outcome. To demonstrate the appropriateness and acceptability of measures of quality of life of children with cancer.
Measured: Once at baseline and each month during the 6-month course of study enrollment.
EORTC PATSAT C-33 questionnaire, adapted appropriately as ePRO to consider parents' perception.
Min Value: 0, Max Value: 100, higher scores indicate a better outcome. To demonstrate the appropriateness and acceptability of measures of parents' satisfaction with cancer care, i.e. the parents' perception of the quality of medical and nursing care as well as the evaluation of the care's organization and the oncology department services. Furthermore to determine usage and evaluation of the MyPal apps including the gamified ePRO for children with cancer.
Measured: Once at baseline and each month during the 6-month course of study enrollment.
Impact on Family Scale questionnaire as ePRO.
Higher scale scores indicate a worse outcome. To demonstrate the appropriateness and acceptability of measures of the impact of pediatric illness on the family, specifically with regards to financial impact, family-social impact and personal strain.
Measured: Once at baseline and each month during the 6-month course of study enrollment.
EQ-5D-3L questionnaire as ePRO.
Min Value: 11111, Max Value: 33333, higher scores indicate a worse outcome. To demonstrate the appropriateness and acceptability of measures of parents' quality of life having children with cancer. It will be evaluated with regard to the five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Measured: Once at baseline and each month during the 6-month course of study enrollment.
Uniquely developed web-based online questionnaire.
Higher scores indicate a worse outcome. To determine the impact on health care professionals across Europe due to the integration of ePROs in palliative care by measuring strain parameters etc. caused by the usage of the service which is subject of the study. Furthermore, to contribute to the evidence-base of the effectiveness of ePROs for palliative care for children with cancer
Measured: Once at the end of the overall course of the study or earlier given the case of changing study staff.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start22 Dec 2020
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (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 Leukemia, ChildhoodStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Research and Technology Hellas
- Sponsor type
- University, hospital or other
- Collaborators
- Universität des Saarlandes, Brno University Hospital, Hannover Medical School
- Responsible party
- Sponsor
- Investigators
- Kostas Stamatopoulos, MD, Study chair, Representative of the Sponsor: Centre for Research & Technology HellasAnnette Sander, MD, Principal investigator, Medical School HannoverPetr Lokaj, MD, Principal investigator, Brno University HospitalNorbert Graf, Professor MD, Study director, Universität des SaarlandesNorbert Grad, Professor MD, Principal investigator, Universität des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381221
- Sponsor's protocol ID
- MyPal4Kids
- Other IDs
- DRKS00021458, 825872, U1111-1251-0043
- Acronym
- MyPal4Kids
- Status last verified
- Mar 2022
- First submitted
- 27 Apr 2020
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research data will not be published as no consent has been obtained for this. In addition, it is sensitive data derived from a vulnerable patient group, i.e. children in palliative care. The research results will only be published in anonymized form and after statistical and qualitative evaluation. The study protocol will be published in a scientific journal. The analyses will be conducted until the end of the project. Publications will be made in accordance with the established criteria for publication of the research results, which can be found in the study protocol, as well as in accordance with national data protection guidelines and internationally applicable provisions of the basic data protection regulation.
Publications
Payne S, Begovic D, Salifu Y, Nelson A, Payne C, Downing J, Natsiavas P, Ling J. Applying Digital Health in Cancer and Palliative Care in Europe: Policy Recommendations from an International Expert Workshop (MyPal Project). J Palliat Med. 2024 Feb;27(2):216-223. doi: 10.1089/jpm.2023.0309. Epub 2023 Sep 22.
PubMed 37738323Meyerheim M, Karamanidou C, Payne S, Garani-Papadatos T, Sander A, Downing J, Stamatopoulos K, Ling J, Payne C, Scarfo L, Lokaj P, Maramis C, Graf N. MyPal-Child study protocol: an observational prospective clinical feasibility study of the MyPal ePRO-based early palliative care digital system in paediatric oncology patients. BMJ Open. 2021 Apr 13;11(4):e045226. doi: 10.1136/bmjopen-2020-045226.
PubMed 33849855
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Clinical Feasibility Study of the MyPal ePRO-based Early Palliative Care Digital System in Paediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT04381221
- Acronym / sponsor ID
- MyPal4Kids / MyPal4Kids
- Conditions
- Leukemia, Childhood, Solid Tumor, Childhood
- Keywords
- Patient-Reported Outcome (PRO), electronic Patient-Reported Outcome (ePRO), Patient-Reported Outcome Measure (PROM), Palliative Care for Children, Supportive Care for Children, Serious Game, eHealth, Mobile Applications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre for Research and Technology HellasUniversity, hospital or other
- Collaborators
- Universität des Saarlandes, Brno University Hospital, Hannover Medical School
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 8 May 2020 (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 main aim of the study is the evaluation of the feasibility of comprehensive service which has been developed while considering patient-orientated needs. With regard to the study, apps have been developed for both groups of participants, parents and their child which suffers from cancer. These apps aim at supporting the documentation and communication of the own condition. This includes for example a video game which can be played via tablet or smartphone in which questions appear addressing the personally perceived burden by children amongst other things. Participants of the study are children between 6 and 17 years of age which suffer from leukemia or tumors. Further participants of the study are at least one of the patient's parents. It is an observational study. Within the course of the study, the usual treatment is not altered actively by the study, it is, however, supplemented by questionnaires which will be analyzed being anonymized after the end of the study running time.
Detailed description
The study is designed as observational prospective feasibility study. The main objective is to assess the feasibility of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems, which aim at supporting the communication between the patients, their parents and the treating medical healthcare professionals. Participants of the study are pediatric oncology patients between 6 and 17 years of age and at least one of their parents, receiving treatment at one of the participating clinical centers due to leukemia or solid tumors. With regard to the study, apps have been developed for both groups of participants, which includes inter alia a game in which questions about burden considering symptoms can be answered by the children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants will be recruited in each of the three participating clinical centers. Besides the children patients, an additional group of participants is constituted by the corresponding child's parents. At least one of the parents will be asked to participate in the study as well.
Key inclusion criteria (10 listed)
- 6-17 years of age
- Diagnosed with paediatric leukaemia or solid cancer in the past 12 months
- Receiving anti-cancer treatment at one of the participating clinical site
- Have age-appropriate speaking, reading and comprehension skills in either the German or the Czech language
- Provide signed + informed consent from parents or legal representative and the assent form by all children from the age of 14 years. These documents had been evaluated positively by IEC.
Key exclusion criteria (2 listed)
- Anyone who is not able to participate in the study according to the clinical judgment of the site chief investigator or any other authorized person of the research team. This judgment has to be documented for each child not being enrolled.
- Anyone who is not able to participate in the study according to the clinical judgment of the site chief investigator or any other authorized person of the research team. This judgment has to be documented for each parent not being enrolled.
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
Recruitment rate, defined as percentage of patients eligible for the study from all patients who were screened for the study.
Time frame: Regularly each month in the course of 6-month course of study enrollment.
This contributes to the primary study objective: to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care and pediatric oncology by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
Participation rate, defined as percentage of recruited patients who completed at least 70% of the scheduled questionnaires for 6 months out of all patients eligible for the study
Time frame: Regularly each month in the course of 6-month course of study enrollment
This contributes to the primary study objective: to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
Adherence rate to the different components of the MyPal services by documentation of user behavior and qualitative analysis
Time frame: Regularly each month in the course of 6-month course of study enrollment
This contributes to the primary study objective: to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
Premature discontinuation rate, defined as percentage of recruited patients who have not been followed-up until the end of 6-month course of study enrollment (withdrawal, death or less than 70% completed questionnaires)
Time frame: Regularly each month in the course of 6-month course of study enrollment
This contributes to the primary study objective: to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
System Usability Scale
Time frame: At the end of the 6-month course of study enrollment
Min Value: 0, Max Value: 100, higher scores indicate a better outcome. Quantitative data to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
Structured Interviews and Focus Groups
Time frame: At the end of the 6-month course of study enrollment
Qualitative data to assess the feasibility and acceptability of a comprehensive, patient-centred service for palliative care in children with cancer by adapting and advancing ePRO systems. Further to identify differences between the participating clinical medical centers. This outcome measure also contributes to the secondary objective which is to determine the usage and evaluation of the MyPal apps including the gamified ePRO by children with cancer.
6 secondary outcomes
Digital adaption of the Mini-SSpedi / SSPedi questionnaires as ePRO.
Time frame: Once at baseline and several times a week during the 6-month course of study enrollment. The frequency of single questions depends on severity of reported symptom burden.
PedsQL(TM) Cancer Module questionnaire as ePRO.
Time frame: Once at baseline and each month during the 6-month course of study enrollment.
EORTC PATSAT C-33 questionnaire, adapted appropriately as ePRO to consider parents' perception.
Time frame: Once at baseline and each month during the 6-month course of study enrollment.
Impact on Family Scale questionnaire as ePRO.
Time frame: Once at baseline and each month during the 6-month course of study enrollment.
EQ-5D-3L questionnaire as ePRO.
Time frame: Once at baseline and each month during the 6-month course of study enrollment.
Uniquely developed web-based online questionnaire.
Time frame: Once at the end of the overall course of the study or earlier given the case of changing study staff.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Derived from this study: PubMed 37738323Payne S, Begovic D, Salifu Y, Nelson A, Payne C, Downing J, Natsiavas P, Ling J. Applying Digital Health in Cancer and Palliative Care in Europe: Policy Recommendations from an International Expert Workshop (MyPal Project). J Palliat Med. 2024 Feb;27(2):216-223. doi: 10.1089/jpm.2023.0309. Epub 2023 Sep 22.
- Derived from this study: PubMed 33849855Meyerheim M, Karamanidou C, Payne S, Garani-Papadatos T, Sander A, Downing J, Stamatopoulos K, Ling J, Payne C, Scarfo L, Lokaj P, Maramis C, Graf N. MyPal-Child study protocol: an observational prospective clinical feasibility study of the MyPal ePRO-based early palliative care digital system in paediatric oncology patients. BMJ Open. 2021 Apr 13;11(4):e045226. doi: 10.1136/bmjopen-2020-045226.
- MyPal project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. The research data will not be published as no consent has been obtained for this. In addition, it is sensitive data derived from a vulnerable patient group, i.e. children in palliative care. The research results will only be published in anonymized form and after statistical and qualitative evaluation. The study protocol will be published in a scientific journal. The analyses will be conducted until the end of the project. Publications will be made in accordance with the established criteria for publication of the research results, which can be found in the study protocol, as well as in accordance with national data protection guidelines and internationally applicable provisions of the basic data protection regulation.
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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.
Kostas Stamatopoulos, MD study chair
Representative of the Sponsor: Centre for Research & Technology Hellas
Annette Sander, MD principal investigator
Medical School Hannover
Petr Lokaj, MD principal investigator
Brno University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Childhood and Solid Tumor, Childhood, run by Centre for Research and Technology Hellas at 3 sites in 2 countries.
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 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: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Czechia. 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 Norbert Graf, Professor MD (+49 68411628411, graf@uks.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate, defined as percentage of patients eligible for the study from all patients who were screened for the study. (time frame: Regularly each month in the course of 6-month course of study enrollment.). The study lists 6 primary outcomes in all. 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 NCT04381221, 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 29 Mar 2022.