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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04488432
Other study ID # 29BRC19.0137
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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