Second Malignant Neoplasms After Childhood ALL Therapy

Completed

• Conditions: Acute Lymphoblastic Leukemia

• Registration Number: NCT01476462
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

Development of a second neoplasm (SMN) during or after therapy for childhood acute lymphoblastic leukemia (ALL) is a rare event generally associated with a poor prognosis. In this international study we analyze subtypes of SMN in relation to their initial leukemia characteristics and treatment, and their subsequent overall survival.

Detailed Description

To explore epidemiology, potential risk factors and survival rates of second cancers occurring as the first event in childhood acute lymphoblastic leukemia the involved study groups will collect anonymous data on all such cases diagnosed within the last decades to form a common database with predefined variables comprising the clinical, biological, and cytogenetic characteristics (myeloid neoplasias only) as well as outcome. Furthermore, we will register the clinical, biological, and cytogenetic characteristics of the acute lymphoblastic leukemia as well as type of treatment given.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-04
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-22
• Study Completion: 2011-12
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-23
• Last Update Posted: 2012-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 642

Inclusion Criteria

• Diagnosed with childhood acute lymphoblastic leukemia
• Diagnosis of second cancer before December 31st 2007

Exclusion Criteria

• Uncertainty if the second cancer has emerged from the same original leukemic clone

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pattern of SMN subtypes	At 20 years from diagnosis	Pattern of the main groups of SMN and their clinical charactiristics
Overall survival by subtype	At 10 years from diagnosis of SMN	Overall survival by the main SMN subtypes (myeloid malignancies, brain tumors, lymphomas, sarcomas, carcinomas, others)
Risk factors for development of SMN	At 20 years from ALL diagnosis	Identification of risk factors linked to the interval to SMN, the subtype of SMN, and the survival after. These risk factors are clinical characteristics of ALL or the anti-ALL therapy administered

Trial Locations

Locations (1)

Kjeld Schmiegelow; 🇩🇰 Copenhagen, Denmark