Primary Brain TumorPTBNCT05660499
Impact of the Development of Pediatric Palliative Care
An observational study of Primary Brain Tumor, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Despite medical advances, cancer remains the leading cause of death by disease in children. Brain tumors are the second most common cause of cancer in children after leukemia, representing 25% of pediatric cancers. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Primary Brain Tumor
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2021to 31 Dec 2023
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: - Patient less than 17 years of age suffering from a primary brain tumor
Who may be able to join
- Patient less than 17 years of age
- Suffering from a primary brain tumor
- Died during the period 2009-2010 or during the period 2019-2020
- Follow-up in one of the Pediatric Oncology departments participating in the study (Strasbourg, Besançon, Dijon, Nancy and Reims)
- Absence of refusal expressed in the medical file by the parents or the holder(s) of parental authority concerning the reuse of the child's personal data for research purposes.
Who cannot join
- Refusal expressed in the medical file by the parents or the holder(s) of parental authority concerning the reuse of the child's personal data for research purposes
- Patient with a brain tumor secondary to another cancer
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de soins Palliatifs - CHU de Strasbourg - France
Strasbourg, 67091
Nadine COJEAN, MD, 33 6 21 11 16 01, nadine.cojean@chru-strasbourg.fr
Nadine COJEAN, MD
About this study
Official title: Assessment of the Presence of Symptoms of End-of-life Discomfort and Their Management in Children With a Primary Brain Tumor in the Grand Est Region. Impact of the Development of Pediatric Palliative Care
Despite medical advances, cancer remains the leading cause of death by disease in children.
Brain tumors are the second most common cause of cancer in children after leukemia, representing 25% of pediatric cancers.
Read more
The overall survival rate is about 50% with extremes ranging from less than 5% to more than 90% depending on the histological type of brain tumor.
The end of life of children with a brain tumor is marked by the possibility of discomfort symptoms, painful or not, and by a progressive neurological deterioration, which makes the management of these children complex for both families and health professionals.
Over the last decade, the concept of palliative care has been increasingly integrated into pediatric onco-hematology services with the primary objective of better symptom control in a global approach to the child and his or her family in order to aim at a better quality of life.
Read the detailed description
The main objective of the study is to compare the occurrence and management of end-of-life symptoms in children who died of a primary brain tumor over 2 periods, in 2009 - 2010 and in 2019 - 2020, followed in the Pediatric Oncology departments of Strasbourg, Besançon, Dijon, Nancy and Reims.
- Conditions
- Primary Brain Tumor
- Keywords
- Primary Brain Tumor, Pediatric Palliative Care
- Medical subject headings
- Brain Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of symptoms of physical or psychological discomfort in the last 4 months of life
Measured: up to the last 4 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start15 Feb 2021
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Brain TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660499
- Sponsor's protocol ID
- 8137
- Acronym
- PTB
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2022
- Last updated
- 14 Dec 2023
- 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 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Presence of Symptoms of End-of-life Discomfort and Their Management in Children With a Primary Brain Tumor in the Grand Est Region. Impact of the Development of Pediatric Palliative Care
- ClinicalTrials.gov ID
- NCT05660499
- Acronym / sponsor ID
- PTB / 8137
- Conditions
- Primary Brain Tumor
- Keywords
- Primary Brain Tumor, Pediatric Palliative Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Dec 2022 (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.
Despite medical advances, cancer remains the leading cause of death by disease in children.
Brain tumors are the second most common cause of cancer in children after leukemia, representing 25% of pediatric cancers.
The overall survival rate is about 50% with extremes ranging from less than 5% to more than 90% depending on the histological type of brain tumor.
The end of life of children with a brain tumor is marked by the possibility of discomfort symptoms, painful or not, and by a progressive neurological deterioration, which makes the management of these children complex for both families and health professionals.
Over the last decade, the concept of palliative care has been increasingly integrated into pediatric onco-hematology services with the primary objective of better symptom control in a global approach to the child and his or her family in order to aim at a better quality of life.
Detailed description
The main objective of the study is to compare the occurrence and management of end-of-life symptoms in children who died of a primary brain tumor over 2 periods, in 2009 - 2010 and in 2019 - 2020, followed in the Pediatric Oncology departments of Strasbourg, Besançon, Dijon, Nancy and Reims.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- - Patient less than 17 years of age suffering from a primary brain tumor
Key inclusion criteria (5 listed)
- Patient less than 17 years of age
- Suffering from a primary brain tumor
- Died during the period 2009-2010 or during the period 2019-2020
- Follow-up in one of the Pediatric Oncology departments participating in the study (Strasbourg, Besançon, Dijon, Nancy and Reims)
- Absence of refusal expressed in the medical file by the parents or the holder(s) of parental authority concerning the reuse of the child's personal data for research purposes.
Key exclusion criteria (2 listed)
- Refusal expressed in the medical file by the parents or the holder(s) of parental authority concerning the reuse of the child's personal data for research purposes
- Patient with a brain tumor secondary to another cancer
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
Presence of symptoms of physical or psychological discomfort in the last 4 months of life
Time frame: up to the last 4 months of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
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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.
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 Primary Brain Tumor, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 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 14 Dec 2023. 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 France. 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 Nadine COJEAN, MD (33 6 21 11 16 01, nadine.cojean@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of symptoms of physical or psychological discomfort in the last 4 months of life (time frame: up to the last 4 months of life). 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 14 Dec 2023.