Childhood Acute Lymphoblastic Leukaemia: Follow-Up

NCT03545659 | Completed

• 1 other identifier: ALL-Relapse
• Study Type: observational
• Target: 277
• Locations: 5 countries
• Sites: 5

Brief Summary

Over the past decades, advances in treatment have led to an increasing number of children who survive cancer, resulting in a growing population of childhood cancer survivors. After end of cancer treatment on common protocols survivors are enrolled in non-harmonized follow-up programs with frequent visits and blood samples. However, the evidence for the value of these follow-up programs with respect to the effect on detecting relapse and the effects on overall survival is scarce. The aim of the study is to give a comprehensive description of the detection mode of relapsed acute lymphoblastic leukaemia (ALL), including symptoms and blood test results. Further, we aim to evaluate if the mode of detection affects survival.

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence

Outcome Measures

Primary Outcomes (1)

• Detection mode

  The proportion of relapses diagnosed at a routine visit vs. relapses diagnosed at an extra scheduled visit.

  Investigators will review medical charts up to three months before the diagnosis of a relapse. Relapses will be categorized to be diagnosed by either a routine visit or an extra scheduled visit.

Secondary Outcomes (1)

• Survival

  Time-to-Event measures (up to 23 years from date of relapse until censoring)

Interventions

Mode of relapse/SMN detection OTHER

Mode of relapse/SMN detection: whether the relapse/SMN was diagnosed because of symptoms of leukaemia or diagnosed at a routine visit in the outpatient clinic.

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be identified in the Nordic Society of Paediatric Haematology and Oncology ALL database.

You may qualify if:

• diagnosed with pre-B or T-cell ALL in the Nordic countries (Denmark, Sweden, Norway, Finland or Iceland)
• included in the NOPHO ALL-92, ALL-2000 or ALL-2008 trials
• treated in a Paediatric Department
• developing a relapse/SMN after cessation of maintenance therapy before 31st of December 2016

You may not qualify if:

• hematopoietic stem cell transplantation in first complete remission

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (5)

Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Department of Paediatrics and Adolescent Medicine, Turku University Hospital

Turku, 20521, Finland

Location

The National University Hospital of Iceland

Reykjavik, 101, Iceland

Location

Department of Childhood Oncology, University Hospital Tromsø

Tromsø, 9038, Norway

Location

Department of Paediatric Oncology, Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Henrik Schrøder, Professor

  Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 4, 2018
• Study Start: September 4, 2018
• Primary Completion: December 30, 2020
• Study Completion: January 20, 2021
• Last Updated: September 1, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); SE (1); DK (1); FI (1); IC (1)