The research is devoted to studying the features of the metabolic syndrome in cancer survivors in childhood is supposed to answer the following questions:
Condition or disease |
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Metabolic Syndrome |
Study Type : | Observational |
Estimated Enrollment : | 400 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Study of the Pathogenic Mechanisms of Metabolic Syndrome at the Background of Genetically Determined Insulin Resistance in Childhood Cancer Survivors |
Actual Study Start Date : | November 20, 2018 |
Estimated Primary Completion Date : | September 20, 2021 |
Estimated Study Completion Date : | December 20, 2022 |
Group/Cohort |
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Russkoe pole
400 patients
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Ages Eligible for Study: | 5 Years to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Participants for this study will be patients of "Russkoe Pole" cohort, the study designed to evaluate health among children and adolescents survivors of childhood leukemia and lymphoma as they age. Participants in RPC undergo risk-based medical screening according to the Standards of Medical Insurance for rehabilitation of Cancer treated patients.
To be eligible for RPC, cancer survivors must has been treated at Russian children oncology clinics by MB-ALL/ BFM-NHL and be 17 years of age or younger, and at least 6 months from the completion of the therapy. All the patients will has exhaustively full epicrisis of medical history with cumulative doses of medications. coz RPC is a retrospective cohort study with ongoing recruitment (additional survivors become eligible over time).
Inclusion Criteria:
Exclusion Criteria:
Contact: Elena V. Zhukovskaya, MD | +79154145145 | elena_zhukovskay@mail.ru | |
Contact: Tatiana V. Nasedkina, PhD | +79169092440 | tanased06@rambler.ru |
Russian Federation | |
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology | Recruiting |
Moscow, Russian Federation, 117997 | |
Contact: Alexander F Karelin, PhD +74952876570 alexandr.karelin@gmail.com | |
Sub-Investigator: Anna E Gavrilova, PhD |
Study Chair: | Melissa M. Hudson, MD | St. Jude Children's Research Hospital Memphis, TN 38105 |
Tracking Information | |||||||||
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First Submitted Date | December 7, 2018 | ||||||||
First Posted Date | December 12, 2018 | ||||||||
Last Update Posted Date | December 20, 2018 | ||||||||
Actual Study Start Date | November 20, 2018 | ||||||||
Estimated Primary Completion Date | September 20, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
Genetic risk [ Time Frame: 12 months ] The detection of NSP associated with metabolic syndrome in children and adolescents after childhood cancer.
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Metabolic Syndrome in Childhood Cancer Survivors | ||||||||
Official Title | Study of the Pathogenic Mechanisms of Metabolic Syndrome at the Background of Genetically Determined Insulin Resistance in Childhood Cancer Survivors | ||||||||
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:
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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: Specific Aim 1. Evaluate the frequency and clinical features of the metabolic syndrome in childhood cancer survivors. Hypothesis 1A: Components of the metabolic syndrome are realizing in children and adolescents at all stages of therapy of leukemia and lymphomas, can influence the development of complications and late toxic effects. Hypothesis 1B: Initial health conditions (abnormal IBM, family history, comorbid diseases); drug's toxicity could influence to the appearance of early manifestation of metabolic syndrome. Specific Aim 2: Evaluate the contribution of functional polymorphisms in candidate genes to metabolic syndrome outcomes among childhood cancer patients. Hypothesis 2A: Genetic polymorphisms involved in the regulation of the insulin resistance and cancer medications during treatment contribute to the development of metabolic syndrome in childhood cancer survivors. Specific Aim 3: Assess the extent to which genetic predictors, doses of drugs, risk factors improve the discriminatory performance of standard clinical prediction models for metabolic syndrome outcomes among childhood cancer survivors. Hypothesis 3 A: Development of metabolic syndrome in cancer patients depends of genetic determinants and toxic effects of antitumor therapy. Secondary Aim 1: Assess the definition of metabolic syndrome in cohort of patients of leukemia and lymphoma and survivors. Hypothesis 1A: Episodes of triglyceridemic, insulin resistance (Hyperglycemia, HOMA>2,7, Steroid Diabetes) during the treatment could be the base evidence marker of Metabolic Syndrome in patients treated by antitumor therapy. Hypothesis 1 B: Endothelial dysfunction as a clinical component of metabolic syndrome is responsible for cardiovascular abnormalities in cancer survivors. Exploratory Aim 1: Assess the association of biomarkers and genetic predictors among childhood cancer survivors with therapeutic exposures (chemotherapy and/or radiation therapy) and metabolic syndrome. Evaluation: Eligible persons who consent to participate in this trial will be asked to do the following:
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Probability Sample | ||||||||
Study Population |
Participants for this study will be patients of "Russkoe Pole" cohort, the study designed to evaluate health among children and adolescents survivors of childhood leukemia and lymphoma as they age. Participants in RPC undergo risk-based medical screening according to the Standards of Medical Insurance for rehabilitation of Cancer treated patients. To be eligible for RPC, cancer survivors must has been treated at Russian children oncology clinics by MB-ALL/ BFM-NHL and be 17 years of age or younger, and at least 6 months from the completion of the therapy. All the patients will has exhaustively full epicrisis of medical history with cumulative doses of medications. coz RPC is a retrospective cohort study with ongoing recruitment (additional survivors become eligible over time). |
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Condition | Metabolic Syndrome | ||||||||
Intervention | Not Provided | ||||||||
Study Groups/Cohorts | Russkoe pole
400 patients
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
400 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | December 20, 2022 | ||||||||
Estimated Primary Completion Date | September 20, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 5 Years to 15 Years (Child) | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts |
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Listed Location Countries | Russian Federation | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03773718 | ||||||||
Other Study ID Numbers | 0925-0586 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | ||||||||
Study Sponsor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | ||||||||
Verification Date | December 2018 |