About this trial
This study describes the ProspectiveMaleAYA cohort, a multicentre, prospective, longitudinal European study designed to investigate the long-term impact of cancer and cancer treatments on reproductive and endocrine health in adolescent and young adult (AYA) male cancer patients. Addressing major gaps in standardized prospective data, particularly for long-term fertility, hypogonadism, and the effects of newer systemic therapies, the study will harmonize data collection across centres and follow patients from diagnosis through post-treatment survivorship.
Comprehensive clinical, oncologic, reproductive, hormonal, biological, and patient-reported outcomes will be collected at predefined intervals to evaluate testicular dysfunction, fertility impairment, oligo/azoospermia, sexual health, and quality of life. Sub-cohorts will enable focused analyses of genetic and epigenetic sperm changes, whole-genome sequencing to identify susceptibility to reproductive and organ toxicity, accelerated aging markers following specific treatments, access to and satisfaction with fertility counselling, and sexual health dysfunctions. The overarching aim is to identify risk factors and predictive markers, develop individualized risk stratification and prediction models, and support precision, patient-centred survivorship care for male AYA cancer survivors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects with male internal and external genitalia
Age at cancer diagnosis 15-39 years old
Subjects planned to or having received oncologic treatment
Subjects able to provide semen sample
Disqualifiers
individuals presenting with relapse or secondary cancers at time of inclusion
subjects who were not treated with oncological treatment
subjects who underwent bilateral orchiectomy
patients with a diagnosis of azoospermia or testicular failure previously to cancer diagnosis
Trial population
Multi-center study on European AYA patient cohorts. Prospective observational multicohort study including male AYA cancer patients enrolled after a diagnosis of primary cancer and followed at 1, 2 and 3 years post diagnosis. The cohort database will be maintained to allow additional follow-up \>3 years after reconsent to allow for further longitudinal research. The subjects will be recruited at \~16 European Centres with expertise in oncofertility.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Constitution of a harmonized RedCap database
Incidence of azoo/oligozoo/normozoospermia according to the type of cancer treatment.
Incidence of overt and compensated hypogonadism according to the type of cancer treatment through the measurement of Testosterone, LH, FSH (Inhibin B) pre/post treatment.
Correlation between hormonal values /routine sperm parameters and clinical characteristics (testis volume, andrological history) at baseline with the development of azoo/oligozoospermia and/or hypogonadism post-therapy according to the type of treatment.
Secondary outcomes
Frequency of severe sperm DNA fragmentation according to the type of cancer treatment at different time points (pre- and post-therapy)
Subcohort 1
Frequency of alterations in sperm DNA methylation (target genes)
Subcohort 1
Whole-genome sequencing database including data from subset of patients
Subcohort 2
Database of validated genetic loci and associated with risk of persistent azoo/oligozoospermia and hypogonadism
Subcohort 2
Locations
Sponsors and contacts
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Karolinska Institutet
Lead sponsor
Karolinska University Hospital
Collaborator
University of Edinburgh
Collaborator
University of Florence
Collaborator
Linkoeping University
Collaborator
Heidelberg University
Collaborator
Medical University Innsbruck
Collaborator
Ospedale Policlinico San Martino
Collaborator
University of Tartu
Collaborator
University of Leipzig
Collaborator
University of Bern
Collaborator
Université Libre de Bruxelles
Collaborator
Region Stockholm
Collaborator
University of Padova
Collaborator
University of Roma La Sapienza
Collaborator
University Hospital, Rouen
Collaborator
Fundacio Puigvert
Collaborator
Semmelweis University
Collaborator
Lund University
Collaborator
KU Leuven
Collaborator
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