Stem Cell TransplantFeProCAYANCT06692868
Fertility Protection for Children, Adolescents and Young Adults
An observational study of Stem Cell Transplant and Stem Cell Transplantation, run by University of Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stem Cell Transplant, Stem Cell Transplantation, Oncological Outcomes
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 9 Dec 2024to Nov 2044
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Sektion Pädiatrische Endokrinologie und Diabetologie
Ulm, Baden-Wurttemberg, 89075
Miriam Wilhelm, Dr., +49 731 500 56947, miri.wilhelm@uniklinik-ulm.de
Pauline Kleger, M.Sc., +49 731 500 57406, pauline.kleger@uniklinik-ulm.de
About this study
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:
Read more
- 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.
Read the detailed description
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:
- Can predictive factors or combined predictor variables for fertility disorders during follow-up be developed based on detailed clinical and laboratory phenotyping of patients before and after exposure to gonadotoxic therapies (e.g., therapeutic exposures, endocrinological markers, anthropometric markers such as body composition, genetic predispositions including risk SNPs and epigenetics)?
- What unmet needs, concerns, and challenges regarding potential fertility impairments exist in different CAYA age groups and their parents, and how do these unmet needs affect the fertility-related quality of life of those affected?
- How can current practices in fertility preservation and counseling for fertility preservation be systematically captured, with the goal of improving clinical care structures (healthcare research)?
These research questions will be addressed within the framework of a multimodal research program, specifically through:
- Development and implementation of a database for the structured collection of therapy-related endocrinological, anthropometric, and laboratory parameters of patients before and after oncological therapy (or stem cell transplantation), as well as during follow-up care at the Department of Pediatrics and Adolescent Medicine, University Medical Center Ulm, Germany.
- Identification of predictors for fertility disorders:
- Therapeutic exposures during primary and secondary therapy
- Endocrinological markers
- Anthropometric markers (body composition)
- Genetic predispositions
- Prospective evaluation of the prevalence and cumulative incidence of fertility disorders in boys and girls during childhood and adolescence, including endocrinological and metabolic late effects.
- Documentation of medical interventions, such as fertility-preserving measures before therapy, endocrinological treatments for late effects, and reproductive medical measures to support future parenthood (e.g., ICSI, IVF, IUI, oocyte transfer, etc.).
- Assessment of previous fertility-preservation measures and counseling efforts for fertility preservation. The long-term goal is to improve the quality of patient care in endocrinological follow-up, focusing on fertility-related parameters after oncological diseases through the structured collection of relevant data.
- Evaluation of fertility-related quality of life and informational needs at different time points during the course of the disease.
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).
- Conditions
- Stem Cell Transplant, Stem Cell Transplantation, Oncological Outcomes, Oncological Patients, Oncological Children, Fertility
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 0 - >20 years after diagnosis or start of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start9 Dec 2024
- Primary completionNov 2044 (estimated)
- Study completionNov 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Prof. Dr. Martin Wabitsch, University of Ulm
- Investigators
- Christian Denzer, Prof. Dr., Principal investigator, Ulm University Medical Centre - Division of Paediatric Endocrinology and DiabetesMartin Wabitsch, Prof. Dr., Study chair, Ulm University Medical Centre - Division of Paediatric Endocrinology and Diabetes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692868
- Sponsor's protocol ID
- FeProCAYA
- Acronym
- FeProCAYA
- Status last verified
- Jan 2025
- First submitted
- 14 Nov 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Protection for Children, Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT06692868
- Acronym / sponsor ID
- FeProCAYA / FeProCAYA
- Conditions
- Stem Cell Transplant, Stem Cell Transplantation, Oncological Outcomes, Oncological Patients, Oncological Children, Fertility
- Keywords
- FeProCAYA, Fertility protection, Endocrinological follow-up after oncological disease, children, fertility, adolescents, young adults, TYA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- Nov 2044 (estimated)
- Study completion
- Nov 2044 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Can predictive factors or combined predictor variables for fertility disorders during follow-up be developed based on detailed clinical and laboratory phenotyping of patients before and after exposure to gonadotoxic therapies (e.g., therapeutic exposures, endocrinological markers, anthropometric markers such as body composition, genetic predispositions including risk SNPs and epigenetics)?
- What unmet needs, concerns, and challenges regarding potential fertility impairments exist in different CAYA age groups and their parents, and how do these unmet needs affect the fertility-related quality of life of those affected?
- How can current practices in fertility preservation and counseling for fertility preservation be systematically captured, with the goal of improving clinical care structures (healthcare research)?
These research questions will be addressed within the framework of a multimodal research program, specifically through:
- Development and implementation of a database for the structured collection of therapy-related endocrinological, anthropometric, and laboratory parameters of patients before and after oncological therapy (or stem cell transplantation), as well as during follow-up care at the Department of Pediatrics and Adolescent Medicine, University Medical Center Ulm, Germany.
- Identification of predictors for fertility disorders:
- Therapeutic exposures during primary and secondary therapy
- Endocrinological markers
- Anthropometric markers (body composition)
- Genetic predispositions
- Prospective evaluation of the prevalence and cumulative incidence of fertility disorders in boys and girls during childhood and adolescence, including endocrinological and metabolic late effects.
- Documentation of medical interventions, such as fertility-preserving measures before therapy, endocrinological treatments for late effects, and reproductive medical measures to support future parenthood (e.g., ICSI, IVF, IUI, oocyte transfer, etc.).
- Assessment of previous fertility-preservation measures and counseling efforts for fertility preservation. The long-term goal is to improve the quality of patient care in endocrinological follow-up, focusing on fertility-related parameters after oncological diseases through the structured collection of relevant data.
- Evaluation of fertility-related quality of life and informational needs at different time points during the course of the disease.
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).
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 20 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mono-centric, prospective cohort study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and cumulative incidence of endocrine sequelae of cancer treatments and SCT during childhood
Time frame: 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
Time frame: 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.
1 secondary outcome
Assessment of fertility-related quality of life
Time frame: 0 - >20 years after diagnosis or start of therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Project overview and information resources on research program and work packages (in German)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Stem Cell Transplant
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Denzer, Prof. Dr. principal investigator
Ulm University Medical Centre - Division of Paediatric Endocrinology and Diabetes
Martin Wabitsch, Prof. Dr. study chair
Ulm University Medical Centre - Division of Paediatric Endocrinology and Diabetes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cell Transplant and Stem Cell Transplantation, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Denzer, Prof. Dr. (+49 731 500 57056, christian.denzer@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and cumulative incidence of endocrine sequelae of cancer treatments and SCT during childhood (time frame: 0 - >20 years after diagnosis or start of therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.