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Completed

NCT Number: NCT04488432

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

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.

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Key information

Conditions

Endocrine System Diseases Adrenal Gland Diseases Adrenal Insufficiency Bone Diseases Bone Diseases, Metabolic Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest - Endocrinology and Diabetology Department

Brest, 29200, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Adrenal insuffisiency prevalence

    Time frame: 12 month post-alloHSCT

    insulin hypoglycemia test

Secondary outcomes

  1. Hypothyroidism prevalence

    Time frame: 12 month post-alloHSCT

    fT4, TSH

  2. Growth hormon Deficiency prevalence

    Time frame: 12 month post-alloHSCT

    insulin hypoglycemia test

  3. Premature ovarian failure prevalence

    Time frame: 12 month post-alloHSCT

    FSH, LH, estradiol

  4. Prevalence of elevated FSH in men

    Time frame: 12 month post-alloHSCT

    FSH, testosterone

  5. Prevalence of low bone mineral density

    Time frame: 12 month post-alloHSCT

    dual X-ray absorptiometry

  6. Prevalence of obesity

    Time frame: 12 month post-alloHSCT

    BMI

  7. Prevalence of dyslipidemia

    Time frame: 12 month post-alloHSCT

  8. Prevalence of hyperglycemia and insulin-resistance

    Time frame: 12 month post-alloHSCT

    glycemia and HOMA2-IR index

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: ENDOCALLOGREFF

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2020
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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