Endocrine System DiseasesENDOCALLOGREFFNCT04488432
Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant
An observational study of Endocrine System Diseases and Osteoporosis, run by University Hospital, Brest at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Endocrine System Diseases, Osteoporosis, Metabolic Syndrome
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2019to 27 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- Child, Adult, Older adult
Study population: Patients treated with allo-HSCT after puberty from 2006 to 2016 in our University Hospital of Brest, adult at the endocrine exploration.
Who may be able to join
- patients treated with allo-HSCT from 2006 to 2016 for a malignant hematologic disease
- adult and in complete remission at exploration.
Who cannot join
- anteriority of brain radiotherapy
- prior HSCT
- pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU de Brest - Endocrinology and Diabetology Department
Brest, 29200
About this study
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.
Read the 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.
- Medical subject headings
- Endocrine System Diseases, Osteoporosis, Metabolic Syndrome, Adrenal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Adrenal insuffisiency prevalence
insulin hypoglycemia test
Measured: 12 month post-alloHSCT
Secondary outcomes (8)
Hypothyroidism prevalence
fT4, TSH
Measured: 12 month post-alloHSCT
Growth hormon Deficiency prevalence
insulin hypoglycemia test
Measured: 12 month post-alloHSCT
Premature ovarian failure prevalence
FSH, LH, estradiol
Measured: 12 month post-alloHSCT
Prevalence of elevated FSH in men
FSH, testosterone
Measured: 12 month post-alloHSCT
Prevalence of low bone mineral density
dual X-ray absorptiometry
Measured: 12 month post-alloHSCT
Prevalence of obesity
BMI
Measured: 12 month post-alloHSCT
Prevalence of dyslipidemia
Measured: 12 month post-alloHSCT
Prevalence of hyperglycemia and insulin-resistance
glycemia and HOMA2-IR index
Measured: 12 month post-alloHSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start27 Nov 2019
- Primary completion27 Nov 2019
- Study completion27 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine System DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488432
- Sponsor's protocol ID
- 29BRC19.0137
- Acronym
- ENDOCALLOGREFF
- Status last verified
- Sep 2020
- First submitted
- 23 Jul 2020
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant
- ClinicalTrials.gov ID
- NCT04488432
- Acronym / sponsor ID
- ENDOCALLOGREFF / 29BRC19.0137
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with allo-HSCT after puberty from 2006 to 2016 in our University Hospital of Brest, adult at the endocrine exploration.
Key inclusion criteria (2 listed)
- patients treated with allo-HSCT from 2006 to 2016 for a malignant hematologic disease
- adult and in complete remission at exploration.
Key exclusion criteria (3 listed)
- anteriority of brain radiotherapy
- prior HSCT
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adrenal insuffisiency prevalence
Time frame: 12 month post-alloHSCT
insulin hypoglycemia test
8 secondary outcomes
Hypothyroidism prevalence
Time frame: 12 month post-alloHSCT
Growth hormon Deficiency prevalence
Time frame: 12 month post-alloHSCT
Premature ovarian failure prevalence
Time frame: 12 month post-alloHSCT
Prevalence of elevated FSH in men
Time frame: 12 month post-alloHSCT
Prevalence of low bone mineral density
Time frame: 12 month post-alloHSCT
Prevalence of obesity
Time frame: 12 month post-alloHSCT
Prevalence of dyslipidemia
Time frame: 12 month post-alloHSCT
Prevalence of hyperglycemia and insulin-resistance
Time frame: 12 month post-alloHSCT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocrine System Diseases and Osteoporosis, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adrenal insuffisiency prevalence (time frame: 12 month post-alloHSCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.