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

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT04488432
Collaborator
(none)
45
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    45 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant
    Actual Study Start Date :
    Nov 27, 2019
    Actual Primary Completion Date :
    Nov 27, 2019
    Actual Study Completion Date :
    Nov 27, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Adrenal insuffisiency prevalence [12 month post-alloHSCT]

      insulin hypoglycemia test

    Secondary Outcome Measures

    1. Hypothyroidism prevalence [12 month post-alloHSCT]

      fT4, TSH

    2. Growth hormon Deficiency prevalence [12 month post-alloHSCT]

      insulin hypoglycemia test

    3. Premature ovarian failure prevalence [12 month post-alloHSCT]

      FSH, LH, estradiol

    4. Prevalence of elevated FSH in men [12 month post-alloHSCT]

      FSH, testosterone

    5. Prevalence of low bone mineral density [12 month post-alloHSCT]

      dual X-ray absorptiometry

    6. Prevalence of obesity [12 month post-alloHSCT]

      BMI

    7. Prevalence of dyslipidemia [12 month post-alloHSCT]

    8. Prevalence of hyperglycemia and insulin-resistance [12 month post-alloHSCT]

      glycemia and HOMA2-IR index

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 75 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU de Brest - Endocrinology and Diabetology Department Brest France 29200

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT04488432
    Other Study ID Numbers:
    • 29BRC19.0137
    First Posted:
    Jul 28, 2020
    Last Update Posted:
    Sep 11, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Osteoporosis
    Metabolic Syndrome
    Metabolic Diseases
    Adrenal Insufficiency
    Endocrine System Diseases

    Study Results

    No Results Posted as of Sep 11, 2020