Fertility Protection for Children, Adolescents and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Prevalence and cumulative incidence of endocrine sequelae of cancer treatments and SCT during childhood
研究概览
简要总结
This study focuses on improving fertility preservation and long-term care for children, adolescents, and young adults (CAYA) undergoing cancer treatments or stem cell transplantation. These treatments can harm fertility, and ensuring that patients receive the right support and follow-up care is critical.
The main study goals are:
- Understanding Fertility Risks: Researchers aim to identify factors that predict fertility problems after cancer treatments, such as the type of therapy, hormone levels, body composition, or genetic predispositions.
- Addressing Patient and Family Needs: The program will explore the concerns, needs, and challenges faced by young patients and their parents regarding fertility. It will also examine how these issues affect their quality of life.
- Improving Clinical Care: Current practices in fertility preservation and counseling will be studied to identify gaps and improve care structures.
To achieve these goals, the program will:
- Create a database to collect and analyze medical data from patients before, during, and after cancer treatments.
- Study the prevalence and long-term effects of fertility problems in young patients.
- Document medical interventions like fertility preservation methods (e.g., freezing eggs or sperm) and treatments for late effects.
- Assess patients' and families' fertility-related quality of life and their informational needs.
Ultimately, the project aims to establish an interdisciplinary center to support fertility preservation and improve the quality of care for young patients facing cancer and its treatments.
详细描述
The protection and preservation of fertility is particularly important for patients with tumor diseases prior to cell-damaging therapies, especially in pediatric oncology and during stem cell transplantation.
Fertility preservation in CAYA (Children, Adolescents, and Young Adults) remains a topic that receives limited attention in everyday clinical practice. While it has been addressed in pediatric oncology for years, it is often inconsistently implemented in daily ward routines and rarely adheres to clinical guidelines.
A rational strategy for fertility-preserving and endocrinological follow-up care should consider not only the therapeutic modalities employed in light of the patient's underlying disease but also the age and gender of the patient at the time of therapy.
The structured documentation of critical risk factors for the manifestation of fertility-restricting endocrinological late effects, as well as precise longitudinal documentation, are therefore of immediate importance in clinical patient care. They ensure the quality of diagnostic and therapeutic processes and outcomes and enable both retrospective and prospective scientific investigations.
The following key questions are central to this effort:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Prevalence and cumulative incidence of endocrine sequelae of cancer treatments and SCT during childhood
时间窗: 0 - >20 years after diagnosis or start of therapy
Prospective evaluation of the prevalence and cumulative incidence of fertility disorders, including endocrinological and metabolic late effects, in childhood cancer survivors and children and adolescents who underwent SCT for malignant and non-malignant conditions during long-term follow-up care.
Predictors for fertility disorders in childhood cancer and SCT survivors
时间窗: 0 - >20 years after diagnosis or start of therapy
Identification of predictors for fertility disorders in childhood cancer survivors and patients, who underwent SCT during childhood, including: * Therapeutic exposures during primary and secondary therapy, * Endocrinological markers, * Anthropometric markers (e.g., body composition), * Genetic predisposition.
次要结局
- Assessment of fertility-related quality of life(0 - >20 years after diagnosis or start of therapy)
研究者
Prof. Dr. Martin Wabitsch
Pediatric endocrinologist
University of Ulm