Study of the Pathogenic Mechanisms of Metabolic Syndrome at the Background of Genetically Determined Insulin Resistance in Childhood Cancer Survivors
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- The frequency of metabolic syndrome
Study Overview
Brief Summary
The research is devoted to studying the features of the metabolic syndrome in cancer survivors in childhood is supposed to answer the following questions:
- How can metabolic syndrome be diagnosed in the Russian population of survivors of acute lymphoblastic leukemia and non-Hodgkin's lymphomas?
- What are the features of the clinical symptoms of metabolic syndrome in this category of patients?
- Which genetic mutations are found in cancer survivors of patients with metabolic syndrome; Which of these mutations can be considered as protective or vice versa predisposing to the development of metabolic syndromes? Is the metabolic syndrome associated with an increased frequency of toxic complications of therapy during the intensive stages?
Detailed Description
Brief Overview:
The remarkable progress in developing curative therapy for childhood cancer over the last 4 to 5 decades has increased awareness of the serious cancer treatment-related late effects experienced by long-term survivors such as premature mortality early deaths, second primary cancers, organ dysfunction (heart, lung, endocrine system), fertility impairment, cognitive deficits, and reduced quality of life. Endocrine disorders, which occur in 30% to 70% of childhood cancer survivors, are among the most frequent late effects of anticancer therapy. Survivors treated with radiation and alkylating agent chemotherapy for hematological malignancies and CNS tumors are at a particularly high risk for endocrine dysfunction.
Most anticancer drugs act directly or indirectly by modifying intracellular metabolism. Therefore, high frequency of acute and late cancer treatment-related organ toxicity can result in metabolic disorders. For example, steroid-induced hypercortism blocks glycolysis and results in insulin resistance of tissues. Insulin resistance is associated with earlier manifestation of diabetes mellitus, obesity etc. The clinical sequelae of metabolic syndrome developing in childhood cancer survivors may include insulin resistance, fasting hyperglycemia, endothelial failure, obesity, dyslipidemia, hypertension, chronic fatigue syndrome, motor and behavioral disorders.
Modern genetics make it possible to create a basis for a personalized approach to the prevention of early and late toxic effects caused by anticancer therapy and the rehabilitation of the childhood cancer survivors.
Objectives:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 5 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Cancer survivors:
- •Treatment with chemotherapy and/or radiation therapy for a primary ALL/NHL diagnosed prior to age 17 years.
- •≤ 15 years of age at the time of enrollment.
- •No cytostatic drugs uptake during the study.
Exclusion Criteria
- •Diagnosis of diabetes mellitus types 1 or 2 types before antitumor therapy
- •Active oncological disease
- •History of allogeneic hematopoietic cell transplant
- •The renouncement of participation from the patient or legally authorized representative
Outcomes
Primary Outcomes
The frequency of metabolic syndrome
Time Frame: 12 months
The frequency of diagnosed metabolic syndrome in the cohort of children and adolescents with leukemia and lymphomas
Secondary Outcomes
- Genetic risk(12 months)