Clinical trial NCT04488432: Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant
Official title: Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endocrine System Diseases
Osteoporosis
Metabolic Syndrome
Adrenal Insufficiency
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with allo-HSCT after puberty from 2006 to 2016 in our University Hospital of Brest, adult at the endocrine exploration.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adrenal insuffisiency prevalence
timeFrame: 12 month post-alloHSCT
Secondary outcomes:
measure: Hypothyroidism prevalence
timeFrame: 12 month post-alloHSCT
measure: Growth hormon Deficiency prevalence
timeFrame: 12 month post-alloHSCT
measure: Premature ovarian failure prevalence
timeFrame: 12 month post-alloHSCT
measure: Prevalence of elevated FSH in men
timeFrame: 12 month post-alloHSCT
measure: Prevalence of low bone mineral density
timeFrame: 12 month post-alloHSCT
measure: Prevalence of obesity
timeFrame: 12 month post-alloHSCT
measure: Prevalence of dyslipidemia
timeFrame: 12 month post-alloHSCT
measure: Prevalence of hyperglycemia and insulin-resistance
timeFrame: 12 month post-alloHSCT
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest - Endocrinology and Diabetology Department
Study officials:
References: