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Not yet recruitingNCT06564220Updated Aug 21, 2024

Testicular Adrenal Rest Tumor in Congenital Adrenal Hyperplasia Patients Attending Assuit University Children Hospital

An observational study in Testicular Adrenal Rest Tumor and Congenital Adrenal Hyperplasia, sponsored by Assiut University. Not yet recruiting. Open to male participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
4 Years to 18 Years
Sex
Male
01

Study summary

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]

02

Conditions studied

  • Testicular Adrenal Rest Tumor
  • Congenital Adrenal Hyperplasia
03

In context

Adrenal Hyperplasia, Congenital

101 studies on the registry are indexed under Adrenal Hyperplasia, Congenital; 28 are open to participants now.

This study's planned enrollment of 30 is below the median of 61 across 44 observational studies indexed under Adrenal Hyperplasia, Congenital.

Browse Adrenal Hyperplasia, Congenital studies →

Lead sponsor

Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 18 Years
Sexes eligible
Male
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients with other adrenal insufficiency cause and Congenital adrenal hyperplasia that progressed to true precocious puberty
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

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 18404975 ↗
  • Aycan 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 23057653 ↗
  • Engels 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 30882882 ↗
  • Al-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 34470837 ↗
  • Chaudhari 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 29330018 ↗
  • Eyer 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 37845103 ↗
  • Rivera-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 37029011 ↗
  • Stikkelbroeck 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 11739428 ↗
  • Tresoldi 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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2024; primary completion for Oct 2025, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2024
First posted
Aug 21, 2024
StartEst.
Oct 2024
Primary completionEst.
Oct 2025
CompletionEst.
Dec 2025
Last update
Aug 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06564220
Lead sponsor
Assiut University
Responsible party
Amira Refaat Zain El-Abidin Zahran (71515,Assuit, Assiut University) — Principal investigator
First posted
Aug 21, 2024
Start date
Oct 2024 (estimated)
Primary completion
Oct 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Aug 21, 2024

Study contacts

Amira R Zain el Abidin
Contact
amira.r.zain@gmail.com
01020456650
Hanaa A Mohamed, Professor
Contact
hae50@aun.edu.eg
01064747613
Shimaa K Mohamed
study director · Lecturer of pediatric, faculty of medicine Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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