Frequency and Prediction of Therapy-induced Testicular Dysfunction in AYA Cancer Survivors (ProspectiveMaleAYA)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
研究概览
简要总结
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.
详细描述
In the past two decades, knowledge regarding the gonadotoxicity of cancer treatments and their impact on fertility and pregnancy outcomes has expanded. However, prospective, standardized, longitudinal data remain largely unavailable, particularly for:
- long-term endocrine and reproductive outcomes,
- effects of novel systemic therapies (e.g., immunotherapy, targeted therapies)
To address this gap, we will conduct a prospective, multicentre, longitudinal cohort study (ProspectiveMaleAYA cohort) in adolescent and young adult (AYA) male cancer patients.
Participants will be enrolled for this study after having received a diagnosis of primary cancer (no relapse or secondary cancers) and if they will receive or are already receiving oncological treatment. Clinical, oncologic, reproductive, endocrine, biological and patient-reported data will be collected at predefined follow-up intervals. Substudies including analyses of biological materials will be conducted in sub-cohorts.
The study aims to harmonize data collection across participating European centres and to set up a large-scale network structure of emerging data collection programmes to evaluate the gonadotoxic risk, including the prevalence and course of testicular dysfunction and/or fertility impairment and oligo/azoospermia following specific treatments, identification of further risk factors and predictive markers to enhance precision survivorship research in this field. In addition to clinical information, whole genome sequencing data will be generated for selected individuals with evidence of varying impact of gonadotoxic therapies on reproductive function. The aim is to find genetic variants associated with risk of reproductive and organ toxicity, and to build and enhance individual predictive risk models for gonadotoxic therapies. Additionally, data on sexual health, quality of life and subjective health status shall be analysed to support patient-centric care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 39 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Kenny Rodriguez-Wallberg
Study coordinator
Karolinska Institutet