Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
7000 participants
OBSERVATIONAL
2023-12-01
2038-12-31
Brief Summary
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The main questions it aims to answer are:
* in females, if cancer therapies reduce the Anti-Müllerian hormone (AMH) concentration (ovarian reserve);
* in males, if cancer therapies reduce sperm concentration (sperm quality).
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Detailed Description
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The data, which are mainly part of the routine clinical care, will be collected by the physicians and added to the REDcap study registry. Patients will be coded by the center to be able to follow them up. Each center will only have access to its own registry data set. Access to the total data set is only permitted for the principal investigator and the specific sub-investigators.
Data collection before the start of gonadotoxic treatment will be performed for 5 years.
Data collection after the end of gonadotoxic treatment will be performed for 10 years (time points: at 12-15 months, at 5 years and at 10 years).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cancer female participants
Fertility status before and after gonadotoxic treatment
Blood samples for analysis
Test hormone levels in blood
Satisfaction evaluation
Participant satisfaction assessment
Quality of Life questionnaire
The World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF)
Cancer male participants
Fertility status before and after gonadotoxic treatment
Blood samples for analysis
Test hormone levels in blood
Sperm samples for analysis
Spermiogram
Satisfaction evaluation
Participant satisfaction assessment
Quality of Life questionnaire
The World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF)
Interventions
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Blood samples for analysis
Test hormone levels in blood
Sperm samples for analysis
Spermiogram
Satisfaction evaluation
Participant satisfaction assessment
Quality of Life questionnaire
The World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF)
Eligibility Criteria
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Inclusion Criteria
* Willing to participate;
* Austria: 14-50 years old (adolescents and adults), Germany: 18-50 years old, Switzerland: 14-50 years old (adolescents and adults);
* Serum hormone analysis before gonadotoxic therapy (females) or serum hormone analysis and sperm analysis before gonadotoxic therapy (males).
Exclusion Criteria
* Language barrier.
14 Years
50 Years
ALL
No
Sponsors
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University of Bern
OTHER
Michael von Wolff
OTHER
Responsible Party
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Michael von Wolff
Prof. Dr. med. Michael von Wolff
Principal Investigators
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Michael von Wolff, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Insel Gruppe AG, University Hospital Bern
Locations
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University Women's Hospital (Inselspital)
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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von Wolff M, Germeyer A, Bottcher B, Magaton IM, Marcu I, Pape J, Sanger N, Nordhoff V, Roumet M, Weidlinger S. Evaluation of the Gonadotoxicity of Cancer Therapies to Improve Counseling of Patients About Fertility and Fertility Preservation Measures: Protocol for a Retrospective Systematic Data Analysis and a Prospective Cohort Study. JMIR Res Protoc. 2024 Mar 20;13:e51145. doi: 10.2196/51145.
Weidlinger S, Graber S, Bratschi I, Pape J, Kollar A, Karrer T, von Wolff M. A Systematic Review of the Gonadotoxicity of Osteosarcoma and Ewing's Sarcoma Chemotherapies in Postpubertal Females and Males. J Adolesc Young Adult Oncol. 2024 Aug;13(4):597-606. doi: 10.1089/jayao.2023.0185. Epub 2024 Apr 17.
Study Documents
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Document Type: Study Protocol
View DocumentRelated Links
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A platform for gonadotoxicity of cancer therapies
Other Identifiers
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KLS 5650-08-2022
Identifier Type: OTHER
Identifier Source: secondary_id
KEK Bern 2022-02284
Identifier Type: -
Identifier Source: org_study_id
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