Fertility Protection for Children, Adolescents and Young Adults

NCT06692868 | Recruiting

• 1 other identifier: FeProCAYA
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Stem Cell Transplant; Stem Cell Transplantation; Oncological Outcomes; Oncological Patients; Oncological Children; Fertility; Fertility Protection; Endocrinological Late-effects; Paediatric Oncology; CAYA; Survivors

Keywords

FeProCAYA; Fertility protection; Endocrinological follow-up after oncological disease; children; fertility; adolescents; young adults; TYA; teenagers and young adults; paediatric oncology; follow-up care; endocrinological late-effects; survivors; stem cell transplant; stem cell transplantation; CAYA

Outcome Measures

Primary Outcomes (2)

• 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.

  0 - >20 years after diagnosis or start of therapy

• 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.

  0 - >20 years after diagnosis or start of therapy

Secondary Outcomes (1)

• Assessment of fertility-related quality of life

  0 - >20 years after diagnosis or start of therapy

Study Arms (4)

FeProCAYA-Onc

Children, adolescents, young adults (age \<21 years) with a diagnosis of cancer before the initiation of oncological therapy or prior to SCT (stem cell transplantation) for a malignant or non-malignant disease with prospective follow-up.

FeProCAYA-Onc (MidTerm)

Children, adolescents, and young adults with a diagnosis of cancer before the age of 21 years and \>5 years of follow-up after initial cancer diagnosis

FeProCAYA-Onc (long-term)

Adults with a diagnosis of cancer before the age of 21 years and \>20 years of follow-up after initial cancer diagnosis

FeProCAYA-SCT

Children and adolescents (age \<21 years) with a malignant or non-malignant condition requiring stem cell transplantation (SCT) prior to SCT with prospective follow-up.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mono-centric, prospective cohort study.

Children, adolescents, young adults with a diagnosis of cancer before the age of 21 years or Children, adolescents, young adults undergoing SCT for a malignant or non-malignant condition before the age of 21 years treated at the Department of Pediatrics and Adolescent Medicine, University Medical Center Ulm, Germany.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Ulm: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (1)

Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Sektion Pädiatrische Endokrinologie und Diabetologie

Ulm, Baden-Wurttemberg, 89075, Germany

RECRUITING

Related Links

• Project overview and information resources on research program and work packages (in German)

Biospecimen

Retention: SAMPLES WITH DNA

Preservation of DNA and serum

Study Officials

• Christian Denzer, Prof. Dr.

  Ulm University Medical Centre - Division of Paediatric Endocrinology and Diabetes

  PRINCIPAL INVESTIGATOR

• Martin Wabitsch, Prof. Dr.

  Ulm University Medical Centre - Division of Paediatric Endocrinology and Diabetes

  STUDY CHAIR

Central Study Contacts

Christian Denzer, Prof. Dr.

CONTACT

+49 731 500 57056; christian.denzer@uniklinik-ulm.de

Martin Wabitsch, Prof. Dr.

CONTACT

+49 731 500 57401; martin.wabitsch@uniklinik-ulm.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric endocrinologist

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): November 1, 2044
• Study Completion (Estimated): November 1, 2044
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

DE (1)