Acute Lymphoblastic Leukemia Clinical Trial
— MVOOfficial title:
Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic Veno-occlusive Disease in Children With Nephroblastoma or Acute Lymphoblastic Leukemia
Hepatic veno-occlusive diseases (VOD) during cancer treatment in children are serious
toxicities that have occurred with interruptions of chemotherapy and risk of relapse. In
addition, these toxicities have a negative impact on the patient's quality of life, serious
long-term sequelae and are potentially fatal in children.
The risk factors associated with the occurrence of these complications are, to date, unknown,
at the exception to the exposition to certain treatments (6-thioguanine, busulfan,
actinomycin D, radiotherapy, etc.). To understand the effects of this toxicity and those of
susceptibility to the disease becomes a major issue in the treatment of these children.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | January 1, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 18 Years |
Eligibility |
Inclusion Criteria: - Children aged < 18 years old at the time of cancer diagnosis - Having been treated with a single line of treatment for nephroblastoma or ALL, in France between 2000 and 2018, and who did not receive allogeneic hematopoietic stem cell transplantation - Weight greater than 5 kg at inclusion - Informed consent dated and signed by the holder of the parental authority (if minor) or by the patient (if major) to take part in the study - Affiliated to a Social Security scheme Exclusion Criteria: - Unavaibility of constitutional DNA - Person who receive more than one treatment line for nephroblastoma or ALL in childhood or adolescence - Pregnant, lactating or parturient women - Person deprived of their liberty by judicial or administrative decision - Person under psychiatric care under duress - Person subject to legal protection - Person unable to express their consent |
Country | Name | City | State |
---|---|---|---|
France | Univesity Hostipal of Amiens | Amiens | |
France | University Hospital of Bordeaux | Bordeaux | |
France | University of Brest | Brest | |
France | University Hospital of Dijon | Dijon | |
France | Centre Oscar Lambret | Lille | |
France | University Hospital of Limoges | Limoges | |
France | Hôpital La Timone | Marseille | |
France | University Hospital of Nantes | Nantes | |
France | University Hospital of Nice | Nice | |
France | Hôpital Trousseau | Paris | |
France | Institut Curie | Paris | |
France | University Hospital of Poitiers | Poitiers | |
France | University Hospital of Rennes | Rennes | |
France | University Hospital of La Réunion | Saint-Denis | |
France | University Hospital of Tours | Tours | |
France | Gustave Roussy | Villejuif |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlate pharmacogenetic analysis with veno-occlusive disease. | Illumina's "Human Omni2.5-8 v1.3" microarrays explore more than 2,600,000 genetic variants, thus covering the entire genome with more than 300,000 genetic biomarkers in exons. | One day | |
Secondary | Participant characteristics. | Age, sociodemographics, personal and cancer history. | One day |
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