Precursor Cell Lymphoblastic Leukemia-LymphomaNCT03985826
Health Care Utilisation Among Survivors of Childhood Acute Lymphoblastic Leukaemia
An observational study of Precursor Cell Lymphoblastic Leukemia-Lymphoma, run by University of Aarhus at 1 site in Denmark.
Trial summary
Improved understanding of the long-time healthcare utilisation of childhood cancer survivors is relevant as it can be seen as a proxy for the population's morbidity. The investigators will conduct a historic population-based matched cohort study using Danish nationwide registry data. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- What is being tested?
- Diagnosis of and treatment for Acute lymphoblastic leukaemia in childhood
- How many people
- 7,348 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2019to 30 Nov 2019
- 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 18 years
- All sexes
- Child, Adult
Study population: The study population will be identified in the Danish part of the Nordic Society of Paediatric Haematology and Oncology ALL database. A reference cohort (comparison cohort) of individuals will be sampled randomly from the source population matched by age and sex and without a history of childhood cancer in the calendar year where the case was diagnosed (density sampling). For each childhood ALL-patient we will choose ten comparison subjects.
Who may be able to join
- B-precursor ALL and T-ALL enrolled in the NOPHO ALL-92, ALL-2000 and ALL-2008 trials.
- Treated at one of the four Danish paediatric oncology departments
- Age group 1.0-14.9 for the NOPHO ALL-92 and ALL-2000 trials. Age group 1.0-17.9 for the NOPHO ALL-2008 trial.
- Completed maintenance therapy in the time period form 01.01.1997 till 31.12.2016
Who cannot join
- Children with Down syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Care Utilisation Following Childhood Acute Lymphoblastic Leukaemia: A Matched Cohort Study
Improved understanding of the long-time healthcare utilisation of childhood cancer survivors is relevant as it can be seen as a proxy for the population's morbidity.
The investigators will conduct a historic population-based matched cohort study using Danish nationwide registry data. Eligible children are children 1.0-17.9 years diagnosed with Acute lymphoblastic leukaemia (ALL) in Denmark from 1994 till 2016. The primary outcome is yearly contact rates to primary healthcare.
Read the detailed description
Acute lymphoblastic leukaemia (ALL) is the most frequent single form of cancer in children accounting for 40-45 new cases every year in Denmark. Over the past decades, advances in treatment have led to an increasing number of children who survive cancer and more than 80% of children with ALL now become long-term survivors. This means a growing population of childhood ALL survivors. In survivors, the cancer itself and treatment late-effects can lead to ongoing health care use.
Register studies of long-term survivors of childhood cancer have shown an increased risk of hospitalisation compared to the general population. It is mentioned in many of the studies that contact rates could be underestimated when looking at hospital contacts only.
The literature about non-hospital-based contacts with a doctor in childhood cancer survivors is scarce.
- Being tested
- Diagnosis of and treatment for Acute lymphoblastic leukaemia in childhood
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of and treatment for Acute lymphoblastic leukaemia in childhoodOther
The cohort of ALL survivors has all been diagnosed and treated for ALL in childhood
| Study group | Role | What they receive |
|---|---|---|
| Childhood ALL survivors | The cohort of childhood ALL survivors will be identified in the Danish part of the Nordic Society of Paediatric Haematology and Oncology (NOPHO) ALL-Register . Receives: Other: Diagnosis of and treatment for Acute lymphoblastic leukaemia in childhood | |
| Comparison cohort | A reference cohort (comparison cohort) of individuals will be sampled randomly from the source population matched by age and sex and without a history of childhood cancer in the calendar year where the case was diagnosed (density sampling). For each childhood ALL-patient we will choose ten comparison subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The yearly contact rate to general practice for ALL survivors and controls
Analysing longitudinal health care data with analysis of both first and recurrent events
Measured: 1-20 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Sep 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Precursor Cell Lymphoblastic Leukemia-LymphomaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,348 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Research Unit for General Practice, Aarhus University
- Responsible party
- Sponsor
- Investigators
- Peter Vedsted, Professor, Study director, Research Unit for General Practice, Institute for Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985826
- Sponsor's protocol ID
- ID277
- Status last verified
- Jun 2019
- First submitted
- 11 Jun 2019
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jensen KS, Klug Albertsen B, Schroder H, Zalounina Falborg A, Schmiegelow K, Rosthoj S, Callesen MT, Vedsted P. Health care utilisation following childhood acute lymphoblastic leukaemia: a population-based matched cohort study. BMJ Open. 2021 Nov 22;11(11):e049847. doi: 10.1136/bmjopen-2021-049847.
PubMed 34810184
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Care Utilisation Following Childhood Acute Lymphoblastic Leukaemia: A Matched Cohort Study
- ClinicalTrials.gov ID
- NCT03985826
- Acronym / sponsor ID
- ID277
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,348 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Research Unit for General Practice, Aarhus University
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 14 Jun 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.
Improved understanding of the long-time healthcare utilisation of childhood cancer survivors is relevant as it can be seen as a proxy for the population's morbidity.
The investigators will conduct a historic population-based matched cohort study using Danish nationwide registry data. Eligible children are children 1.0-17.9 years diagnosed with Acute lymphoblastic leukaemia (ALL) in Denmark from 1994 till 2016. The primary outcome is yearly contact rates to primary healthcare.
Detailed description
Acute lymphoblastic leukaemia (ALL) is the most frequent single form of cancer in children accounting for 40-45 new cases every year in Denmark. Over the past decades, advances in treatment have led to an increasing number of children who survive cancer and more than 80% of children with ALL now become long-term survivors. This means a growing population of childhood ALL survivors. In survivors, the cancer itself and treatment late-effects can lead to ongoing health care use.
Register studies of long-term survivors of childhood cancer have shown an increased risk of hospitalisation compared to the general population. It is mentioned in many of the studies that contact rates could be underestimated when looking at hospital contacts only.
The literature about non-hospital-based contacts with a doctor in childhood cancer survivors is scarce.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Childhood ALL survivors | – | Other: Diagnosis of and treatment for Acute lymphoblastic leukaemia in childhoodThe cohort of childhood ALL survivors will be identified in the Danish part of the Nordic Society of Paediatric Haematology and Oncology (NOPHO) ALL-Register . |
| Comparison cohort | – | –A reference cohort (comparison cohort) of individuals will be sampled randomly from the source population matched by age and sex and without a history of childhood cancer in the calendar year where the case was diagnosed (density sampling). For each childhood ALL-patient we will choose ten comparison subjects. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The study population will be identified in the Danish part of the Nordic Society of Paediatric Haematology and Oncology ALL database. A reference cohort (comparison cohort) of individuals will be sampled randomly from the source population matched by age and sex and without a history of childhood cancer in the calendar year where the case was diagnosed (density sampling). For each childhood ALL-patient we will choose ten comparison subjects.
Key inclusion criteria (4 listed)
- B-precursor ALL and T-ALL enrolled in the NOPHO ALL-92, ALL-2000 and ALL-2008 trials.
- Treated at one of the four Danish paediatric oncology departments
- Age group 1.0-14.9 for the NOPHO ALL-92 and ALL-2000 trials. Age group 1.0-17.9 for the NOPHO ALL-2008 trial.
- Completed maintenance therapy in the time period form 01.01.1997 till 31.12.2016
Key exclusion criteria (1 listed)
- Children with Down syndrome
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 |
|---|---|---|
| Diagnosis of and treatment for Acute lymphoblastic leukaemia in childhoodThe cohort of ALL survivors has all been diagnosed and treated for ALL in childhood | Other | Childhood ALL survivors |
Primary outcome
The yearly contact rate to general practice for ALL survivors and controls
Time frame: 1-20 years follow-up
Analysing longitudinal health care data with analysis of both first and recurrent events
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 3 Dec 2020.
- Derived from this study: PubMed 34810184Jensen KS, Klug Albertsen B, Schroder H, Zalounina Falborg A, Schmiegelow K, Rosthoj S, Callesen MT, Vedsted P. Health care utilisation following childhood acute lymphoblastic leukaemia: a population-based matched cohort study. BMJ Open. 2021 Nov 22;11(11):e049847. doi: 10.1136/bmjopen-2021-049847.
- Individual participant dataSharing planned: No
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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.
Peter Vedsted, Professor study director
Research Unit for General Practice, Institute for Public Health
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 Precursor Cell Lymphoblastic Leukemia-Lymphoma, run by University of Aarhus at 1 site in Denmark.
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 1 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 3 Dec 2020. 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 Denmark. 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?
The yearly contact rate to general practice for ALL survivors and controls (time frame: 1-20 years follow-up). 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 NCT03985826, which also lists 1 linked publication.
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 3 Dec 2020.