Cancer SurvivorNCT01298388
Study of Long-Term Outcomes of Patients With Acute Lymphoblastic Leukemia Who Were Enrolled as Children on Clinical Trials EORTC-58741, EORTC-58831, EORTC-58832, or EORTC-58881 Between 1971 and 1998
An observational study of Cancer Survivor and Leukemia, run by European Organisation for Research and Treatment of Cancer - EORTC.
Trial summary
RATIONALE: Studying medical records and collecting questionnaires from patients who were enrolled as children in clinical trials for acute lymphoblastic leukemia may help doctors learn about long-term effects of treatment and plan the best treatment. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Cancer Survivor, Leukemia, Long-term Effects Secondary to Cancer Therapy in Children
- What is being tested?
- medical chart review, questionnaire administration and study of socioeconomic and demographic variables
- How many people
- 3,138 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Mar 2013
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS:
- Patients with acute lymphoblastic leukemia (ALL) previously enrolled as children (less than18 years of age at diagnosis) on any of the following clinical trials between 1971 and 1998:
- EORTC-58741
- EORTC-58831
- EORTC-58832
- EORTC-58881
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Assessment of the Long Term Outcome of Childhood ALL Patients Enrolled in EORTC Children's Leukemia Group Trials Between 1971 and 1998
RATIONALE: Studying medical records and collecting questionnaires from patients who were enrolled as children in clinical trials for acute lymphoblastic leukemia may help doctors learn about long-term effects of treatment and plan the best treatment.
PURPOSE: This clinical trial is studying the long-term outcomes of patients with acute lymphoblastic leukemia who were enrolled as children on clinical trials EORTC-58741, EORTC-58831, EORTC-58832, or EORTC-58881 between 1971 and 1998.
Read the detailed description
OBJECTIVES:
- To assess the long-term outcomes (i.e., long-term survival, long-term disease status, occurrence of late adverse effects, occurrence of second cancers, and socioeconomic status of survivors) of patients with acute lymphoblastic leukemia previously enrolled as children on clinical trials EORTC-58741, EORTC-58831, EORTC-58832, or EORTC-58881 between the years of 1971 and 1998.
OUTLINE: Long-term outcome data are collected from the databases about clinical trials EORTC-58741, EORTC-58831, EORTC-58832, or EORTC-58881. Other data collected include the patient's vital status actualization (e.g., alive, dead or lost to follow up, date last known to be alive or date of death), medical records data, and the collection of data from patients confirmed to be alive (e.g., data related to marital status, education, work, insurance, puberty, fertility, and offspring) by questionnaire.
- Being tested
- medical chart review, questionnaire administration, study of socioeconomic and demographic variables
- Keywords
- long-term effects secondary to cancer therapy in children, cancer survivor, recurrent childhood acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia, non-T, non-B childhood acute lymphoblastic leukemia, non-T, non-B, cALLa positive childhood acute lymphoblastic leukemia, non-T, non-B, cALLa negative childhood acute lymphoblastic leukemia, non-T, non-B, cALLa positive, pre-B childhood acute lymphoblastic leukemia, childhood acute lymphoblastic leukemia in remission
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical chart reviewOther
questionnaire administrationOther
study of socioeconomic and demographic variablesOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term survival
Disease status
Late adverse effects
Second cancers
Socioeconomic status of survivors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2013 (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 Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- Enrolment
- 3,138 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Investigators
- Caroline Piette, Study chair, Centre Hospitalier Régional de la CitadelleYves Benoit, MD, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298388
- Sponsor's protocol ID
- CDR0000695273
- Other IDs
- EORTC-58LAE, EU-21106
- Status last verified
- Sep 2011
- First submitted
- 16 Feb 2011
- Last updated
- 16 Sep 2011
- Results posted
- No
Publications
de Ville de Goyet M, Kicinski M, Suciu S, Vandecruys E, Uyttebroeck A, Ferster A, Freycon C, Plat G, Thomas C, Barbati M, Dresse MF, Paillard C, Pluchart C, Simon P, Chantrain C, Minckes O, van der Werff Ten Bosch J, Bertrand Y, Rohrlich P, Millot F, Paulus R, Benoit Y, Piette C; European Organisation for Research, Treatment of Cancer (EORTC) Children's Leukemia Group (CLG). Long-term neurotoxicity among childhood acute lymphoblastic leukaemia survivors enrolled between 1971 and 1998 in EORTC Children Leukemia Group studies. Discov Oncol. 2024 Jan 29;15(1):20. doi: 10.1007/s12672-024-00869-6.
PubMed 38285235Rossi G, Kicinski M, Suciu S, Vandecruys E, Plat G, Uyttebroeck A, Paillard C, Barbati M, Dresse MF, Simon P, Minckes O, Pluchart C, Ferster A, Freycon C, Millot F, van der Werff Ten Bosch J, Chantrain C, Paulus R, de Rojas T, de Schaetzen G, Rohrlich P, Benoit Y, Piette C. Fertility status among long-term childhood acute lymphoblastic leukaemia survivors enrolled between 1971 and 1998 in EORTC CLG studies: results of the 58 Late Adverse Effects study. Hum Reprod. 2021 Dec 27;37(1):44-53. doi: 10.1093/humrep/deab236.
PubMed 34788455
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Long Term Outcome of Childhood ALL Patients Enrolled in EORTC Children's Leukemia Group Trials Between 1971 and 1998
- ClinicalTrials.gov ID
- NCT01298388
- Acronym / sponsor ID
- CDR0000695273
- Keywords
- long-term effects secondary to cancer therapy in children, cancer survivor, recurrent childhood acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia, non-T, non-B childhood acute lymphoblastic leukemia, non-T, non-B, cALLa positive childhood acute lymphoblastic leukemia, non-T, non-B, cALLa negative childhood acute lymphoblastic leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,138 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Jul 2011
- Primary completion
- Mar 2013 (estimated)
- First posted
- 17 Feb 2011 (estimated)
- 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.
RATIONALE: Studying medical records and collecting questionnaires from patients who were enrolled as children in clinical trials for acute lymphoblastic leukemia may help doctors learn about long-term effects of treatment and plan the best treatment.
PURPOSE: This clinical trial is studying the long-term outcomes of patients with acute lymphoblastic leukemia who were enrolled as children on clinical trials EORTC-58741, EORTC-58831, EORTC-58832, or EORTC-58881 between 1971 and 1998.
Detailed description
OBJECTIVES:
- To assess the long-term outcomes (i.e., long-term survival, long-term disease status, occurrence of late adverse effects, occurrence of second cancers, and socioeconomic status of survivors) of patients with acute lymphoblastic leukemia previously enrolled as children on clinical trials EORTC-58741, EORTC-58831, EORTC-58832, or EORTC-58881 between the years of 1971 and 1998.
OUTLINE: Long-term outcome data are collected from the databases about clinical trials EORTC-58741, EORTC-58831, EORTC-58832, or EORTC-58881. Other data collected include the patient's vital status actualization (e.g., alive, dead or lost to follow up, date last known to be alive or date of death), medical records data, and the collection of data from patients confirmed to be alive (e.g., data related to marital status, education, work, insurance, puberty, fertility, and offspring) by questionnaire.
Study design
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| medical chart review | Other | – |
| questionnaire administration | Other | – |
| study of socioeconomic and demographic variables | Other | – |
Primary outcome
Long-term survival
Disease status
Late adverse effects
Second cancers
Socioeconomic status of survivors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2011.
- Derived from this study: PubMed 38285235de Ville de Goyet M, Kicinski M, Suciu S, Vandecruys E, Uyttebroeck A, Ferster A, Freycon C, Plat G, Thomas C, Barbati M, Dresse MF, Paillard C, Pluchart C, Simon P, Chantrain C, Minckes O, van der Werff Ten Bosch J, Bertrand Y, Rohrlich P, Millot F, Paulus R, Benoit Y, Piette C; European Organisation for Research, Treatment of Cancer (EORTC) Children's Leukemia Group (CLG). Long-term neurotoxicity among childhood acute lymphoblastic leukaemia survivors enrolled between 1971 and 1998 in EORTC Children Leukemia Group studies. Discov Oncol. 2024 Jan 29;15(1):20. doi: 10.1007/s12672-024-00869-6.
- Derived from this study: PubMed 34788455Rossi G, Kicinski M, Suciu S, Vandecruys E, Plat G, Uyttebroeck A, Paillard C, Barbati M, Dresse MF, Simon P, Minckes O, Pluchart C, Ferster A, Freycon C, Millot F, van der Werff Ten Bosch J, Chantrain C, Paulus R, de Rojas T, de Schaetzen G, Rohrlich P, Benoit Y, Piette C. Fertility status among long-term childhood acute lymphoblastic leukaemia survivors enrolled between 1971 and 1998 in EORTC CLG studies: results of the 58 Late Adverse Effects study. Hum Reprod. 2021 Dec 27;37(1):44-53. doi: 10.1093/humrep/deab236.
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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.
Caroline Piette study chair
Centre Hospitalier Régional de la Citadelle
Yves Benoit, MD
University Ghent
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Survivor and Leukemia, run by European Organisation for Research and Treatment of Cancer - EORTC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
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 survival. 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?
On the ClinicalTrials.gov record for NCT01298388, 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 16 Sep 2011.