ProspectiveMaleAYA - Frequency and Prediction of Therapy-induced Testicular Dysfunction in AYA Cancer Survivors

Sponsor
Karolinska Institutet
Study ID
NCT07612943
Status
Not Yet Recruiting

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Conditions

  • Cancer
  • Infertility
  • Late Effects
  • Reproduction

Eligibility Criteria

Sex
MALE
Age
15 Years - 39 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
May 29, 2026
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
May 31, 2030
Completion
May 31, 2031

Study Design

Enrollment
1,000 participants (estimated)

Primary Outcome Measure

Constitution of a harmonized RedCap database [ Time Frame: June 2030 ]

Central Contacts

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