An observational study in Stem Cell Transplant, Stem Cell Transplantation and Oncological Outcomes, sponsored by University of Ulm. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by University of Ulm · Observational
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:
To achieve these goals, the program will:
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.
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:
These research questions will be addressed within the framework of a multimodal research program, specifically through:
Identification of predictors for fertility disorders:
FeProCAYA is a part of the collaborative research project FePro-Ulm (https://www.uniklinik-ulm.de/frauenheilkunde-und-geburtshilfe/schwerpunkte/unifee/standard-titel.html), which is funded by the German Federal Ministry of Education and Research (BMBF). FePro-Ulm is an interdisciplinary junior scientists research center for fertility protection and one of five German CERES Excellence Centers for reproductive health (https://www.gesundheitsforschung-bmbf.de/de/interdisziplinaere-nachwuchszentren-fuer-reproduktive-gesundheit-16739.php).
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →University of Ulm is the lead sponsor of 141 studies on the registry; 26 are open to participants now.
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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.
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.
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
Adults with a diagnosis of cancer before the age of 21 years and \>20 years of follow-up after initial cancer diagnosis
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.
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
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
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
Plan to share: Undecided
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