Tokyo, Feb. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060678) titled 'Cryopreservation of Testicular Tissue in Pediatric Cancer Patients' on Feb. 20.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - The University of Osaka
Condition:
Condition - Pediatric Cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to harvest and cryopreserve testicular tissue prior to cancer treatment in pediatric cancer patients who are expected to receive gonadotoxic therapies that may result in male infertility.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Orchiectomy or partial orchiectomy will be performed under general anesthesia.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male
Key inclusion criteria - Male patients scheduled to undergo cancer treatment that may impair spermatogenesis.
Male patients from birth to prepubertal stage with bilaterally descended testes.
Male patients with sufficient testicular volume to allow tissue harvesting.
Male patients deemed fit to undergo general anesthesia and orchiectomy or partial orchiectomy, as determined by the Department of Anesthesiology.
Male patients for whom the primary treating department has reviewed the potential impact of study participation on treatment of the underlying disease and has approved participation in this study.
Male patients for whom written informed consent has been obtained.
Male patients considered appropriate for participation by the principal investigator or sub-investigators.
Key exclusion criteria - Male patients without bilaterally descended testes.
Male patients with known testicular abnormalities.
Male patients with insufficient testicular volume for tissue harvesting.
Male patients capable of ejaculation.
Male patients in whom spermatozoa are present in the testes.
Male patients deemed unfit to undergo general anesthesia and orchiectomy or partial orchiectomy.
Male patients considered inappropriate for anesthesia by the Department of Anesthesiology.
Male patients for whom participation in this study is considered to have a significant negative impact on treatment of the underlying disease and is not approved by the primary treating department.
Male patients for whom written informed consent cannot be obtained.
Male patients considered inappropriate for participation by the principal investigator or sub-investigators.
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 02 Month 20 Day
Anticipated trial start date - 2026 Year 03 Month 20 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069405
Disclaimer: Curated by HT Syndication.
