Fertility Protection for Children, Adolescents and Young Adults

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Ulm

About this trial

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:

1. 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. 2. 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. 3. 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Mono-centric, prospective cohort study.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 4 trial groups
Group A: FeProCAYA-Onc
Group B: FeProCAYA-Onc (MidTerm)
Group C: FeProCAYA-Onc (long-term)
Group D: FeProCAYA-SCT

Trial outcomes

Primary outcomes

1

Prevalence and cumulative incidence of endocrine sequelae of cancer treatments and SCT during childhood

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.

Time frame
0 - >20 years after diagnosis or start of therapy
2

Predictors for fertility disorders in childhood cancer and SCT survivors

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.

Time frame
0 - >20 years after diagnosis or start of therapy

Secondary outcomes

1

Assessment of fertility-related quality of life

Structured and standardized assessment of fertility-related quality of life and informational needs at various time points throughout long-term follow-up care.

Time frame
0 - >20 years after diagnosis or start of therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Ulm

Lead sponsor

German Federal Ministry of Education and Research

Collaborator