The State of Sexual Development in Children With Inherited Epidermolysis Bullosa
NCT ID: NCT05033574
Last Updated: 2021-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2020-12-08
2023-06-01
Brief Summary
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Detailed Description
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Phenotyping of patients with inherited epidermolysis bullosa, taking into account their physical and sexual development, indicators of self-attitude and socialization.
Development of algorithms for individual care for patients with inherited epidermolysis bullosa, including an assessment of the psychological state at different age stages (primary school and adolescence), the volume and form of psychological and pedagogical assistance in complex rehabilitation.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Prepubescent and pubertal girls with an established diagnosis of epidermolysis bullosa simplex
Female patients aged 8 to 18 years with a diagnosis of epidermolysis bullosa simplex.
Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned.
Biochemical study of hormone levels
Biochemical study of the level of follicle-stimulating hormone, luteinizing hormone, estradiol, total testosterone, prolactin, 17-hydroxyprogesterone, dehydroepiandrosterone sulfate, cortisol, insulin, thyroid-stimulating hormone, tetraiodothyronine, thyr
Ultrasound examination
Ultrasound examination of the pelvic organs in girls and the scrotum organs in boys
Radiography of the hands
Determination of bone age using radiography of the hands
Consultation of a medical psychologist
Consultation with a medical psychologist to determine the patient's psychological condition and level of intelligence
Prepubescent and pubertal girls with an established diagnosis of junctional epidermolysis bullosa
Female patients aged 8 to 18 years with a diagnosis of junctional epidermolysis bullosa.
Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned.
Biochemical study of hormone levels
Biochemical study of the level of follicle-stimulating hormone, luteinizing hormone, estradiol, total testosterone, prolactin, 17-hydroxyprogesterone, dehydroepiandrosterone sulfate, cortisol, insulin, thyroid-stimulating hormone, tetraiodothyronine, thyr
Ultrasound examination
Ultrasound examination of the pelvic organs in girls and the scrotum organs in boys
Radiography of the hands
Determination of bone age using radiography of the hands
Consultation of a medical psychologist
Consultation with a medical psychologist to determine the patient's psychological condition and level of intelligence
Prepubescent and pubertal girls with an established diagnosis of epidermolysis bullosa dystrophic
Female patients aged 8 to 18 years with a diagnosis of epidermolysis bullosa dystrophic.
Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned.
Biochemical study of hormone levels
Biochemical study of the level of follicle-stimulating hormone, luteinizing hormone, estradiol, total testosterone, prolactin, 17-hydroxyprogesterone, dehydroepiandrosterone sulfate, cortisol, insulin, thyroid-stimulating hormone, tetraiodothyronine, thyr
Ultrasound examination
Ultrasound examination of the pelvic organs in girls and the scrotum organs in boys
Radiography of the hands
Determination of bone age using radiography of the hands
Consultation of a medical psychologist
Consultation with a medical psychologist to determine the patient's psychological condition and level of intelligence
Prepubescent and pubertal girls with an established diagnosis of Kindler syndrome
Female patients aged 8 to 18 years with a diagnosis of Kindler syndrome. Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned.
Biochemical study of hormone levels
Biochemical study of the level of follicle-stimulating hormone, luteinizing hormone, estradiol, total testosterone, prolactin, 17-hydroxyprogesterone, dehydroepiandrosterone sulfate, cortisol, insulin, thyroid-stimulating hormone, tetraiodothyronine, thyr
Ultrasound examination
Ultrasound examination of the pelvic organs in girls and the scrotum organs in boys
Radiography of the hands
Determination of bone age using radiography of the hands
Consultation of a medical psychologist
Consultation with a medical psychologist to determine the patient's psychological condition and level of intelligence
Prepubescent and pubertal boys with an established diagnosis of epidermolysis bullosa simplex
Male patients aged 8 to 18 years with a diagnosis of epidermolysis bullosa simplex.
Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned.
Biochemical study of hormone levels
Biochemical study of the level of follicle-stimulating hormone, luteinizing hormone, estradiol, total testosterone, prolactin, 17-hydroxyprogesterone, dehydroepiandrosterone sulfate, cortisol, insulin, thyroid-stimulating hormone, tetraiodothyronine, thyr
Ultrasound examination
Ultrasound examination of the pelvic organs in girls and the scrotum organs in boys
Radiography of the hands
Determination of bone age using radiography of the hands
Consultation of a medical psychologist
Consultation with a medical psychologist to determine the patient's psychological condition and level of intelligence
Prepubescent and pubertal boys with an established diagnosis of junctional epidermolysis bullosa
Male patients aged 8 to 18 years with a diagnosis of junctional epidermolysis bullosa.
Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned.
Biochemical study of hormone levels
Biochemical study of the level of follicle-stimulating hormone, luteinizing hormone, estradiol, total testosterone, prolactin, 17-hydroxyprogesterone, dehydroepiandrosterone sulfate, cortisol, insulin, thyroid-stimulating hormone, tetraiodothyronine, thyr
Ultrasound examination
Ultrasound examination of the pelvic organs in girls and the scrotum organs in boys
Radiography of the hands
Determination of bone age using radiography of the hands
Consultation of a medical psychologist
Consultation with a medical psychologist to determine the patient's psychological condition and level of intelligence
Prepubescent and pubertal boys with an established diagnosis of epidermolysis bullosa dystrophic
Male patients aged 8 to 18 years with a diagnosis of epidermolysis bullosa dystrophic.
Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned.
Biochemical study of hormone levels
Biochemical study of the level of follicle-stimulating hormone, luteinizing hormone, estradiol, total testosterone, prolactin, 17-hydroxyprogesterone, dehydroepiandrosterone sulfate, cortisol, insulin, thyroid-stimulating hormone, tetraiodothyronine, thyr
Ultrasound examination
Ultrasound examination of the pelvic organs in girls and the scrotum organs in boys
Radiography of the hands
Determination of bone age using radiography of the hands
Consultation of a medical psychologist
Consultation with a medical psychologist to determine the patient's psychological condition and level of intelligence
Prepubescent and pubertal boys with an established diagnosis of Kindler epidermolysis bullosa
Male patients aged 8 to 18 years with a diagnosis of Kindler syndrome. Based on the results of diagnostic methods, further division of patients into prepubertal and pubertal periods of puberty is planned.
Biochemical study of hormone levels
Biochemical study of the level of follicle-stimulating hormone, luteinizing hormone, estradiol, total testosterone, prolactin, 17-hydroxyprogesterone, dehydroepiandrosterone sulfate, cortisol, insulin, thyroid-stimulating hormone, tetraiodothyronine, thyr
Ultrasound examination
Ultrasound examination of the pelvic organs in girls and the scrotum organs in boys
Radiography of the hands
Determination of bone age using radiography of the hands
Consultation of a medical psychologist
Consultation with a medical psychologist to determine the patient's psychological condition and level of intelligence
Interventions
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Biochemical study of hormone levels
Biochemical study of the level of follicle-stimulating hormone, luteinizing hormone, estradiol, total testosterone, prolactin, 17-hydroxyprogesterone, dehydroepiandrosterone sulfate, cortisol, insulin, thyroid-stimulating hormone, tetraiodothyronine, thyr
Ultrasound examination
Ultrasound examination of the pelvic organs in girls and the scrotum organs in boys
Radiography of the hands
Determination of bone age using radiography of the hands
Consultation of a medical psychologist
Consultation with a medical psychologist to determine the patient's psychological condition and level of intelligence
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. previous treatment with sex steroids or gonadotropins;
3. the presence of endocrine diseases (hypothyroidism, hypercorticism, hyperprolactinemia, diabetes mellitus);
4. the presence of chronic somatic diseases that are not complications of inherited epidermolysis bullosa (bronchopulmonary diseases, cardiovascular diseases, diseases of the urinary system, diseases of the gastrointestinal tract).
8 Years
18 Years
ALL
No
Sponsors
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National Medical Research Center for Children's Health, Russian Federation
OTHER_GOV
Responsible Party
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Locations
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National Medical Research Center for Children's Health
Moscow, , Russia
Countries
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Other Identifiers
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6
Identifier Type: -
Identifier Source: org_study_id
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