Clinical Trials Directory

Trials / Completed

CompletedNCT04488432

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

Status
Completed
Phase
Study type
Observational
Enrollment
45 (actual)
Sponsor
University Hospital, Brest · Academic / Other
Sex
All
Age
16 Years – 75 Years
Healthy volunteers

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.

Conditions

Timeline

Start date
2019-11-27
Primary completion
2019-11-27
Completion
2019-11-27
First posted
2020-07-28
Last updated
2020-09-11

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04488432. Inclusion in this directory is not an endorsement.