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

Metabolic Syndrome Clinical Trial

— ENDOCALLOGREFF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04488432
• Other study ID #: 29BRC19.0137
• Status: Completed
• Start date: November 27, 2019
• Est. completion date: November 27, 2019

Study information

• Verified date: September 2020
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 27, 2019
• Est. primary completion date: November 27, 2019
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Endocrine System Diseases
• Metabolic Diseases
• Metabolic Syndrome
• Osteoporosis

Locations

Country	Name	City	State
France	CHRU de Brest - Endocrinology and Diabetology Department	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adrenal insuffisiency prevalence	insulin hypoglycemia test	12 month post-alloHSCT
Secondary	Hypothyroidism prevalence	fT4, TSH	12 month post-alloHSCT
Secondary	Growth hormon Deficiency prevalence	insulin hypoglycemia test	12 month post-alloHSCT
Secondary	Premature ovarian failure prevalence	FSH, LH, estradiol	12 month post-alloHSCT
Secondary	Prevalence of elevated FSH in men	FSH, testosterone	12 month post-alloHSCT
Secondary	Prevalence of low bone mineral density	dual X-ray absorptiometry	12 month post-alloHSCT
Secondary	Prevalence of obesity	BMI	12 month post-alloHSCT
Secondary	Prevalence of dyslipidemia		12 month post-alloHSCT
Secondary	Prevalence of hyperglycemia and insulin-resistance	glycemia and HOMA2-IR index	12 month post-alloHSCT