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Metabolic Syndrome in Childhood Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773718
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

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?

Condition or disease
Metabolic Syndrome

Show Show detailed description

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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

Resource links provided by the National Library of Medicine


Group/Cohort
Russkoe pole
400 patients



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Genetic risk [ Time Frame: 12 months ]
    The detection of NSP associated with metabolic syndrome in children and adolescents after childhood cancer.



Information from the National Library of Medicine

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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
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).

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773718


Contacts
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Contact: Elena V. Zhukovskaya, MD +79154145145 elena_zhukovskay@mail.ru
Contact: Tatiana V. Nasedkina, PhD +79169092440 tanased06@rambler.ru

Locations
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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         
Sponsors and Collaborators
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Investigators
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Study Chair: Melissa M. Hudson, MD St. Jude Children's Research Hospital Memphis, TN 38105
  Study Documents (Full-Text)

Documents provided by Federal Research Institute of Pediatric Hematology, Oncology and Immunology:
Study Protocol  [PDF] October 12, 2018

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Responsible Party: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
ClinicalTrials.gov Identifier: NCT03773718    
Other Study ID Numbers: 0925-0586
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Federal Research Institute of Pediatric Hematology, Oncology and Immunology:
metabolic syndrome
children
cancer
survivors
genetic
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases