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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04488432

Acronym

ENDOCALLOGREFF

Enrollment

Registered

2020-07-28

Start date

2019-11-27

Completion date

2019-11-27

Last updated

2020-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Insufficiency, Endocrine System Diseases, Metabolic Syndrome, Osteoporosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Adrenal insuffisiency prevalence	12 month post-alloHSCT	insulin hypoglycemia test

Secondary

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

Countries

France

Outcome results