Hyperglycaemia In Childhood Hematologic Malignancies

NCT05525364 | Completed

• 1 other identifier: DIAB-ONCO
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND/AIM: Secondary forms of diabetes are often understudied and underdiagnosed in children and adolescents with cancer. The objectives of this cohort study were to study the incidence and risk factors for hyperglycaemia in leukaemia and lymphoma patients. METHODS: The investigators retrospectively collected 15 years of data from paediatric patients treated for acute lymphoblastic leukaemia (ALL), Hodgkin's lymphoma (HL), and non-Hodgkin's lymphoma (NHL) immediately at cancer diagnosis. They studied risk factors for hyperglycaemia in univariate and multivariate analyses.

Conditions

Diabetes Mellitus Risk

Outcome Measures

Primary Outcomes (3)

• Variables of interests - personal patient data and patient's family history

  The investigators collected personal patient data such as sex, date of birth, country of origin, weight (kilograms), height (centimeters) and gestation at birth, complications during pregnancy (pre- or post-term, events, foetal macrosomia), dysmaturity, hypoglycaemia and hyperglycaemia in the neonatal period, the presence or absence of previous overweight (weight and height used to obtain BMI \> 85th centile)/obesity (BMI \> 95th centile), endocrine disease, autoimmune disease, acanthosis nigricans, sickle cell anaemia, any chronic treatment, date of death if patient died. Regarding the patient's family history, the investigators registered the presence or absence of previous gestational diabetes, polycystic ovarian syndrome, infertility, dystocia, consanguinity, diabetes, metabolic syndrome, sickle cell anaemia, pancreatic or liver surgery.

  Through study completion, an average of two years

• Variables of interests - Cancer and treatment data

  The investigators also gathered information about the primary diagnosis and its treatment: type of cancer, diagnosis date, stage and localization of the tumour, anthropometric data on diagnosis (weight in kilograms, height in meters), tanner stage, blood pressure (systolic and diastolic), treatments protocols (presence or absence of steroids, asparaginase, radiotherapy and HSCT) and the presence of treatment side effects such as steroid-resistant disease, allergy to asparaginase, pancreatitis and steatosis induced by treatment protocol.

  Through study completion, an average of two years

• Variables of interests - Blood glucose and hyperglycemia data

  When the patient developed hyperglycaemia more than twice, the date, the anthropometric data of onset (weight in kilograms, height in meters), the blood pressure, the treatment for the hyperglycaemia (e.g., insulin therapy, metformin), its doses per day, and its duration were reported. To obtain the number of blood glucose levels recorded, all blood glucose measurements from the start of treatment protocol until the end of our study were counted. The duration of blood glucose monitoring was evaluated by counting blood glucose measurements performed without an interruption of more than six months and deceased patients were excluded. To evaluate the percentage of patients having been tested for blood glucose after the maintenance phase, the investigators included only ALL patients treated before 2015 and HL patients treated before 2017 to have a sufficient delay between the end of maintenance phase and the end of our study for the metabolic outcome monitoring.

  Through study completion, an average of two years

Study Arms (1)

Screening of diabetes

Our investigations included patients receiving treatment protocols conferring a diabetogenic risk. These included total body, cranial and abdominal irradiation (respectively TBI, CI and AI), steroids and L-asparaginase. Our cohort was therefore composed of patients treated for acute lymphoblastic leukaemia (ALL), Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL). The patients were stratified according to the presence or absence of hyperglycemia during the treatment protocol and during clinical follow-up, which ended in August 2020. The groups were called the "hyperglycaemia-positive ALL, NHL or HL" and the "hyperglycaemia-free ALL, NHL or HL".

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Our cohort was composed of patients treated for acute lymphoblastic leukaemia (ALL), Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL).

You may qualify if:

• Patients admitted to hemato-onco for acute lymphoblastic leukemia, Hodgkin's lymphoma or non-Hodgkin's lymphoma who are receiving treatments at diabetogenic risk for their cancer (i.e. glucocorticoids, asparaginase, total body irradiation, abdominal and/or cranial radiation)
• Age of the patient at presentation: 0 years - 18 years.
• \- patients under diabetogenic treatment protocols such as glucocorticoids, asparaginase, total body irradiation, abdominal and/or cranial irradiation and hyperglycemia diagnosis according to the 2014 guidelines of the International Paediatric and Adolescent Diabetes Society (ISPAD).

You may not qualify if:

• patients with an incomplete file
• patients with history of the following conditions: previous diabetes (i.e., type 1, type 2, neonatal or monogenic diabetes), pancreatitis, steatosis, Down syndrome, pancreas and liver surgery, kidney disease and previous cancer other than leukaemia and lymphoma.

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc - UCLouvain

Brussels, 1200, Belgium

Location

Study Officials

• Philippe Lysy, MD, PhD

  Cliniques Universitaires Saint-Luc UCLouvain

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: September 1, 2022
• Study Start: June 20, 2019
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)