Testicular biopsies in young boys diagnosed with cancer to preserve future fertility- towards a safe and feasible autologous cell therapy in future.

Conditions: jongens met kanker en hoge kans op onvruchtbaarheid
preserving fertility

Registration Number: NL-OMON52444

Lead Sponsor: Prinses Máxima Centrum voor kinderoncologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

-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 have signed consent. And in case boys > 12
years informed consent will be signed together with the informed consent of
their parents

-For follow up all boys included in the previous cohort at the Amsterdam UMC,
location AMC who have undergone a testicular biopsy prior to start of
chemotherapy during the period 2011-2018.

Exclusion Criteria

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-Successful cryopreservation of testicular tissue in which germ cells can be<br /><br>identified for later use in auto transplantation and follow up of previous<br /><br>cohort (Amsterdam UMC, location AMC) to register possible late complications.<br /><br>The presence of SSCs will be identified based on histological analyses<br /><br>(immuno-) characterization, possibly supported by flowcytometry and single cell<br /><br>sequencing<br /><br><br /><br>-Successful sampling and storage of testicular tissue (cryosurvival of SSCs,<br /><br>ability to propagate SSCs in vitro) in combination with long-term follow-up of<br /><br>possible side-effects of the testicular biopsy in the boy (local defects,<br /><br>endocrine and exocrine function of the remaining testis). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Long-term follow-up of possible side-effects of the testicular biopsy in the<br /><br>boy (local defects, endocrine and exocrine function of the remaining testis),<br /><br>post-pubertal fertility (as determined by semen analysis)and hormonal analysis<br /><br>(FSH LH testosterone and Inhibin B)<br /><br></p><br>