Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant

Completed

• Conditions: Metabolic Syndrome; Adrenal Insufficiency; Endocrine System Diseases; Osteoporosis

• Registration Number: NCT04488432
• Lead Sponsor: University Hospital, Brest

Brief Summary

Allogeneic hematopoietic stem cell transplantations (allo-HSCT) is often indicated in malignant hematologic diseases. Conditioning regimens, used to reduce the tumor burden and to prevent transplant rejection, are based on chemotherapy alone or combined with total body irradiation (TBI). Endocrine complications are frequent transplant-related side effects. Investigators have been well described in children studies but less in adulthood.

The objective of this study is to assess retrospectively endocrine, bone and metabolic disorders in adult patients, 12 months after allo-HSCT.

Detailed Description

Patients \& Methods Inclusion criteria are : patients treated with allo-HSCT from 2006 to 2016 for a malignant hematologic disease; adult and in complete remission at exploration.

Exclusion criteria are : anteriority of brain radiotherapy and prior HSCT.

Twelve months after HSCT, each patient underwent fasting measurement of IGF1, TSH, fT4, FSH, LH, sex steroids, glycemia, insulin level, and lipid profile. Unless contraindication, adrenal and growth hormone functions were assessed with insulin hypoglycemia test. A dual X-ray absorptiometry was also performed.

Investigators will assess the prevalence of endocrine, bone and metabolic disorders 12 months after allo-HSCT and describe some of their risk factors.

Study Timeline

• Study Start: 2019-11-27
• Primary Completion: 2019-11-27
• Study Completion: 2019-11-27
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-28
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• patients treated with allo-HSCT from 2006 to 2016 for a malignant hematologic disease
• adult and in complete remission at exploration.

Exclusion Criteria

• anteriority of brain radiotherapy
• prior HSCT
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adrenal insuffisiency prevalence	12 month post-alloHSCT	insulin hypoglycemia test

Secondary Outcome Measures

Name	Time	Method
Hypothyroidism prevalence	12 month post-alloHSCT	fT4, TSH
Growth hormon Deficiency prevalence	12 month post-alloHSCT	insulin hypoglycemia test
Prevalence of elevated FSH in men	12 month post-alloHSCT	FSH, testosterone
Premature ovarian failure prevalence	12 month post-alloHSCT	FSH, LH, estradiol
Prevalence of low bone mineral density	12 month post-alloHSCT	dual X-ray absorptiometry
Prevalence of obesity	12 month post-alloHSCT	BMI
Prevalence of hyperglycemia and insulin-resistance	12 month post-alloHSCT	glycemia and HOMA2-IR index
Prevalence of dyslipidemia	12 month post-alloHSCT

Trial Locations

Locations (1)

CHRU de Brest - Endocrinology and Diabetology Department; 🇫🇷 Brest, France