Testicular Biopsies in Young Boys Diagnosed with Cancer To Cryopreserve Future Fertility; Towards a Safe and Feasible Future Autologous Cell Therapy
- Conditions
- Cancer in children (Haemotooncologic, solid tumors and brain tumors)
- Registration Number
- NL-OMON22319
- Lead Sponsor
- Prinses Maxima Center for paediatric oncology and stichting bergh in het zadel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 80
4.1Population (base)
Young boys ( defined as Tanner stage P2G2 testes volume < 10cc) who are diagnosed with cancer and who are scheduled to undergo treatment at high risk of infertility (that is cyclophosphamide equivalent dose (CED) of > 4000 mg/m2 or radiotherapy to volumes exposing the testes and high dose stem cell transplantation) and retrospective follow up of the previous cohort Amsterdam UMC, location AMC (102 patients).
Inclusion criteria
-Concerning objective 1 and 2; Young patients with malignancies treated with alkylating agents (CED >4000mg/m2), brain tumours treated with cranio-(spinal) irradiation and alkylating agents, total body irradiation, pelvic irradiation, testicular irradiation, and conditioning for stem cell transplantation. The boys and parents will be given an individual estimate on the probability of infertility in relation to their scheduled treatment..
-Only if parents/legal guardians signed consent.
-Concerning objective 3; All boys included in the previous cohort at the Amsterdam UMC, location AMC (research project NL 27690.000.09) who have undergone a testicular biopsy prior to start of chemotherapy during the period 2009-2018.
Malignancies located in the testis, history of bilateral cryptorchidism or testicular torsion, ability to ejaculate vital spermatozoa on masturbation or electro-stimulated ejaculation. Previous history or increased risk for pre-existing (congenital) gonadal insufficiency or known chromosomal abnormalities that affect male fertility. All pre pubertal boys with cancer not meeting the high risk of infertility standard
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main endpoint will be successful sampling and storage of testicular tissue (that is 75% of the samples to be stored for future stem cell preservation will have germ cells). This can be identified based on histological analyses (immuno-), possibly supported by flowcytometry and single cell sequencing. We aim to prospectively collect testicular material of all young boys with high risk of infertility that provide informed consent in our clinic. We aim to achieve 75% of the samples to be stored for future stem cell preservation to have germ cells. Around 20 male prepubertal boys will fulfill the criteria yearly. We expect 75% patients to give consent and we expect 75% to achieve the main end point. The study will start Q2 2021 and yearly we expect to include 15 patients During the total study period we hope to include 75-80 patients (total study duration 5 years)
- Secondary Outcome Measures
Name Time Method ong-term follow-up of possible side-effects of the testicular biopsy in the boy (local defects, endocrine and exocrine function of the remaining testis), and optional post-pubertal fertility (as determined by semen analysis) Striving to follow up 75% of the total cohort. Total cohort of the previous research study (research project NL 27690.000.09) total of 94 children of whom 80 are still alive. Inclusion of 75% of these children/adults will be around 60 patients who we will follow 1x year x 5 years (2021-2026) . The prospective group will also be followed 1xyear till 2026.