Testicular Adrenal Rest TumorNCT06564220
Testicular Adrenal Rest Tumor in Congenital Adrenal Hyperplasia Patients Attending Assuit University Children Hospital
An observational study of Testicular Adrenal Rest Tumor and Congenital Adrenal Hyperplasia, run by Assiut University.
Trial summary
assessment of the risk factors contributing for TART development in a male child with congenital adrenal hyperplasia. Read more about this study
- Who is it for?
- Ages 4 to 18 years, men only
- Conditions the study is for
- Testicular Adrenal Rest Tumor, Congenital Adrenal Hyperplasia
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 2025
- 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 4 to 18 years
- Men only
- Child, Adult
Study population: male patients diagnosed as congenital adrenal hyperplasia based on clinical manifestations and laboratory investigations from age of 4 years to age of 18 years.
Who may be able to join
- All male patients diagnosed as congenital adrenal hyperplasia based on clinical manifestations and laboratory investigations from age of 4 years to age of 18 years.
Who cannot join
- Patients with other adrenal insufficiency cause and Congenital adrenal hyperplasia that progressed to true precocious puberty
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Testicular Adrenal Rest Tumor in Congenital Adrenal Hyperplasia Patients Attending Assiut University Children Hospital
assessment of the risk factors contributing for TART development in a male child with congenital adrenal hyperplasia.
Read the detailed description
Congenital adrenal hyperplasia (CAH) is one of the most frequent endocrine disorders. It is characterized by deficient activity of one of the enzymes necessary for adrenal Cortisol synthesis. Autosomal recessive inheritance of deficient 21-hydroxylase (21 OH) activity accounts for more than 90% of cases. [1]
One of the most important and frequently detected complications in males with congenital adrenal hyperplasia (CAH) is the development of testicular adrenal rest tumours (TARTs). . [2],[3]
Testicular adrenal rest tumor is a benign tumor originating from adrenal cells within the testicles; the adrenal cells migrate at 8 weeks of gestation from the urogenital ridge along with the gonadal cells to the testicle. The exact mechanism underlying tumor growth and development is still not well understood . [4],[5]
The correct diagnosis of TART is important for differential diagnosis with malignant testis tumors, which need orchiectomy, as opposed to TART, usually treated exclusively with exogenous steroids. [6].
Although TARTs are always benign, their location in the rete testis could obstructs the seminiferous tubules and causes gonadal dysfunction and infertility. Therefore, it is important to detect and treat TARTs at an early stage, especially in adolescents or young adults. [5],[7]
testicular ultrasound should be done in order to evaluate the presence of these lesions, its size, location, and characteristics. [9]
TARTs in children have mostly been presented as case reports in the literature, and only a limited number of studies have described the prevalence of TARTs in large populations of children . [2],[8]
As not all male CAH patients are affected by this complication, attempts have been made to identify the risk factors for the development of TARTs . [7]
- Medical subject headings
- Adrenal Hyperplasia, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Testicular adrenal rest tumor in congenital adrenal hyperplasia patients attending Assiut University Children Hospital
Assessment of risk factors contributing for TART development in a child with congenital adrenal hyperplasia.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Testicular Adrenal Rest TumorStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Refaat Zain El-Abidin Zahran, Assiut University
- Investigators
- Shimaa K Mohamed, Study director, Lecturer of pediatric, faculty of medicine Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564220
- Sponsor's protocol ID
- Testicular adrenal rest tumor
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grunieiro-Papendieck L, Chiesa A, Mendez V, Prieto L. Neonatal screening for congenital adrenal hyperplasia: experience and results in Argentina. J Pediatr Endocrinol Metab. 2008 Jan;21(1):73-8. doi: 10.1515/jpem.2008.21.1.73.
PubMed 18404975Aycan Z, Bas VN, Cetinkaya S, Yilmaz Agladioglu S, Tiryaki T. Prevalence and long-term follow-up outcomes of testicular adrenal rest tumours in children and adolescent males with congenital adrenal hyperplasia. Clin Endocrinol (Oxf). 2013 May;78(5):667-72. doi: 10.1111/cen.12033.
PubMed 23057653Engels M, Span PN, van Herwaarden AE, Sweep FCGJ, Stikkelbroeck NMML, Claahsen-van der Grinten HL. Testicular Adrenal Rest Tumors: Current Insights on Prevalence, Characteristics, Origin, and Treatment. Endocr Rev. 2019 Aug 1;40(4):973-987. doi: 10.1210/er.2018-00258.
PubMed 30882882Al-Ghamdi WM, Shazly MA, Al-Agha AE. Testicular adrenal rest tumors in children with congenital adrenal hyperplasia. Saudi Med J. 2021 Sep;42(9):986-993. doi: 10.15537/smj.2021.42.9.20210257.
PubMed 34470837Chaudhari M, Johnson EK, DaJusta D, Nahata L. Testicular adrenal rest tumor screening and fertility counseling among males with congenital adrenal hyperplasia. J Pediatr Urol. 2018 Apr;14(2):155.e1-155.e6. doi: 10.1016/j.jpurol.2017.11.011. Epub 2017 Dec 21.
PubMed 29330018Eyer de Jesus L, Paz de Oliveira AP, Porto LC, Dekermacher S. Testicular adrenal rest tumors - Epidemiology, diagnosis and treatment. J Pediatr Urol. 2024 Feb;20(1):77-87. doi: 10.1016/j.jpurol.2023.10.005. Epub 2023 Oct 7.
PubMed 37845103Rivera-Hernandez A, Jimenez-Osorio M, Rodriguez-Mencias JP, Escamilla-Castaneda KM, Madrigal-Gonzalez MM, Zurita-Cruz J. Risk factors for testicular adrenal rest tumors in pediatric patients with congenital adrenal hyperplasia. J Pediatr Urol. 2023 Aug;19(4):398.e1-398.e7. doi: 10.1016/j.jpurol.2023.03.028. Epub 2023 Mar 24.
PubMed 37029011Stikkelbroeck NM, Otten BJ, Pasic A, Jager GJ, Sweep CG, Noordam K, Hermus AR. High prevalence of testicular adrenal rest tumors, impaired spermatogenesis, and Leydig cell failure in adolescent and adult males with congenital adrenal hyperplasia. J Clin Endocrinol Metab. 2001 Dec;86(12):5721-8. doi: 10.1210/jcem.86.12.8090.
PubMed 11739428Tresoldi AS, Betella N, Hasenmajer V, Pozza C, Vena W, Fiamengo B, Negri L, Cappa M, Lania AGA, Lenzi A, Isidori AM, Pizzocaro A. Bilateral testicular masses and adrenal insufficiency: is congenital adrenal hyperplasia the only possible diagnosis? First two cases of TARTS described in Addison-only X-linked adrenoleukodystrophy and a brief review of literature. J Endocrinol Invest. 2021 Mar;44(3):391-402. doi: 10.1007/s40618-020-01362-x. Epub 2020 Jul 20.
PubMed 32691371
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testicular Adrenal Rest Tumor in Congenital Adrenal Hyperplasia Patients Attending Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT06564220
- Acronym / sponsor ID
- Testicular adrenal rest tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Aug 2024 (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.
assessment of the risk factors contributing for TART development in a male child with congenital adrenal hyperplasia.
Detailed description
Congenital adrenal hyperplasia (CAH) is one of the most frequent endocrine disorders. It is characterized by deficient activity of one of the enzymes necessary for adrenal Cortisol synthesis. Autosomal recessive inheritance of deficient 21-hydroxylase (21 OH) activity accounts for more than 90% of cases. [1]
One of the most important and frequently detected complications in males with congenital adrenal hyperplasia (CAH) is the development of testicular adrenal rest tumours (TARTs). . [2],[3]
Testicular adrenal rest tumor is a benign tumor originating from adrenal cells within the testicles; the adrenal cells migrate at 8 weeks of gestation from the urogenital ridge along with the gonadal cells to the testicle. The exact mechanism underlying tumor growth and development is still not well understood . [4],[5]
The correct diagnosis of TART is important for differential diagnosis with malignant testis tumors, which need orchiectomy, as opposed to TART, usually treated exclusively with exogenous steroids. [6].
Although TARTs are always benign, their location in the rete testis could obstructs the seminiferous tubules and causes gonadal dysfunction and infertility. Therefore, it is important to detect and treat TARTs at an early stage, especially in adolescents or young adults. [5],[7]
testicular ultrasound should be done in order to evaluate the presence of these lesions, its size, location, and characteristics. [9]
TARTs in children have mostly been presented as case reports in the literature, and only a limited number of studies have described the prevalence of TARTs in large populations of children . [2],[8]
As not all male CAH patients are affected by this complication, attempts have been made to identify the risk factors for the development of TARTs . [7]
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 18 years
- Sex
- Male only
- Age groups
- Child, Adult
- Study population
- male patients diagnosed as congenital adrenal hyperplasia based on clinical manifestations and laboratory investigations from age of 4 years to age of 18 years.
Key inclusion criteria (1 listed)
- All male patients diagnosed as congenital adrenal hyperplasia based on clinical manifestations and laboratory investigations from age of 4 years to age of 18 years.
Key exclusion criteria (1 listed)
- Patients with other adrenal insufficiency cause and Congenital adrenal hyperplasia that progressed to true precocious puberty
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
Testicular adrenal rest tumor in congenital adrenal hyperplasia patients attending Assiut University Children Hospital
Time frame: Baseline
Assessment of risk factors contributing for TART development in a child with congenital adrenal hyperplasia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 18404975Grunieiro-Papendieck L, Chiesa A, Mendez V, Prieto L. Neonatal screening for congenital adrenal hyperplasia: experience and results in Argentina. J Pediatr Endocrinol Metab. 2008 Jan;21(1):73-8. doi: 10.1515/jpem.2008.21.1.73.
- Background: PubMed 23057653Aycan Z, Bas VN, Cetinkaya S, Yilmaz Agladioglu S, Tiryaki T. Prevalence and long-term follow-up outcomes of testicular adrenal rest tumours in children and adolescent males with congenital adrenal hyperplasia. Clin Endocrinol (Oxf). 2013 May;78(5):667-72. doi: 10.1111/cen.12033.
- Background: PubMed 30882882Engels M, Span PN, van Herwaarden AE, Sweep FCGJ, Stikkelbroeck NMML, Claahsen-van der Grinten HL. Testicular Adrenal Rest Tumors: Current Insights on Prevalence, Characteristics, Origin, and Treatment. Endocr Rev. 2019 Aug 1;40(4):973-987. doi: 10.1210/er.2018-00258.
- Background: PubMed 34470837Al-Ghamdi WM, Shazly MA, Al-Agha AE. Testicular adrenal rest tumors in children with congenital adrenal hyperplasia. Saudi Med J. 2021 Sep;42(9):986-993. doi: 10.15537/smj.2021.42.9.20210257.
- Background: PubMed 29330018Chaudhari M, Johnson EK, DaJusta D, Nahata L. Testicular adrenal rest tumor screening and fertility counseling among males with congenital adrenal hyperplasia. J Pediatr Urol. 2018 Apr;14(2):155.e1-155.e6. doi: 10.1016/j.jpurol.2017.11.011. Epub 2017 Dec 21.
- Background: PubMed 37845103Eyer de Jesus L, Paz de Oliveira AP, Porto LC, Dekermacher S. Testicular adrenal rest tumors - Epidemiology, diagnosis and treatment. J Pediatr Urol. 2024 Feb;20(1):77-87. doi: 10.1016/j.jpurol.2023.10.005. Epub 2023 Oct 7.
- Background: PubMed 37029011Rivera-Hernandez A, Jimenez-Osorio M, Rodriguez-Mencias JP, Escamilla-Castaneda KM, Madrigal-Gonzalez MM, Zurita-Cruz J. Risk factors for testicular adrenal rest tumors in pediatric patients with congenital adrenal hyperplasia. J Pediatr Urol. 2023 Aug;19(4):398.e1-398.e7. doi: 10.1016/j.jpurol.2023.03.028. Epub 2023 Mar 24.
- Background: PubMed 11739428Stikkelbroeck NM, Otten BJ, Pasic A, Jager GJ, Sweep CG, Noordam K, Hermus AR. High prevalence of testicular adrenal rest tumors, impaired spermatogenesis, and Leydig cell failure in adolescent and adult males with congenital adrenal hyperplasia. J Clin Endocrinol Metab. 2001 Dec;86(12):5721-8. doi: 10.1210/jcem.86.12.8090.
- Background: PubMed 32691371Tresoldi AS, Betella N, Hasenmajer V, Pozza C, Vena W, Fiamengo B, Negri L, Cappa M, Lania AGA, Lenzi A, Isidori AM, Pizzocaro A. Bilateral testicular masses and adrenal insufficiency: is congenital adrenal hyperplasia the only possible diagnosis? First two cases of TARTS described in Addison-only X-linked adrenoleukodystrophy and a brief review of literature. J Endocrinol Invest. 2021 Mar;44(3):391-402. doi: 10.1007/s40618-020-01362-x. Epub 2020 Jul 20.
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.
Shimaa K Mohamed study director
Lecturer of pediatric, faculty of medicine Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Adrenal Rest Tumor and Congenital Adrenal Hyperplasia, run by Assiut University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira R Zain el Abidin (01020456650, amira.r.zain@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testicular adrenal rest tumor in congenital adrenal hyperplasia patients attending Assiut University Children Hospital (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06564220, which also lists 9 linked publications.
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 21 Aug 2024.