Metabolic Syndrome in Childhood Cancer Survivors

NCT03773718 | Unknown

• 1 other identifier: 0925-0586
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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?

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; children; cancer; survivors; genetic

Outcome Measures

Primary Outcomes (1)

• The frequency of metabolic syndrome

  The frequency of diagnosed metabolic syndrome in the cohort of children and adolescents with leukemia and lymphomas

  12 months

Secondary Outcomes (1)

• Genetic risk

  12 months

Study Arms (1)

Russkoe pole

400 patients

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Research Institute of Pediatric Hematology, Oncology and Immunology: lead

Study Sites (1)

Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology

Moscow, 117997, Russia

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Neoplasms

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Melissa M. Hudson, MD

  St. Jude Children's Research Hospital Memphis, TN 38105

  STUDY CHAIR

Central Study Contacts

Elena V. Zhukovskaya, MD

CONTACT

+79154145145; elena_zhukovskay@mail.ru

Tatiana V. Nasedkina, PhD

CONTACT

+79169092440; tanased06@rambler.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 12, 2018
• Study Start: November 20, 2018
• Primary Completion: September 20, 2021
• Study Completion: December 20, 2022
• Last Updated: December 20, 2018

Record last verified: 2018-12

Locations

RU (1)