Clinical trial · Observational
ProspectiveMaleAYA - Frequency and Prediction of Therapy-induced Testicular Dysfunction in AYA Cancer Survivors
Frequency and Prediction of Therapy-induced Testicular Dysfunction in AYA Cancer Survivors (ProspectiveMaleAYA)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Infertility | — | UNRESOLVED | — |
| Late Effects | — | UNRESOLVED | — |
| Reproduction | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Constitution of a harmonized RedCap database
- timeFrame
- June 2030
- measure
- Incidence of azoo/oligozoo/normozoospermia according to the type of cancer treatment.
- timeFrame
- June 2030
- measure
- 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.
- timeFrame
- June 2030
- measure
- 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.
- timeFrame
- June 2030
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 15 Years
- Maximum age
- 39 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Information available on cancer treatment and medical history * Patients (or parents in case of minors) who signed informed consent Exclusion Criteria: * 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
References
Publications (0)
Data not yet available