Impact of Gonadotoxic Therapies on Fertility

Официальное название

FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies

Обзор

The goal of this observational study is to learn how gonadotoxic treatments (chemotherapies, radiotherapies or immunotherapies) affect the fertility status of participants with cancer. 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).

Подробное описание

This is an international multicenter prospective exploratory study of fertility related data generated mostly routinely in fertility centers in Switzerland belonging to the Swiss network "FertiSAVE" as well as in fertility centers in Germany and Austria belonging to the German-Swiss-Austrian network "FertiPROTEKT" and further international centers who are interested to participate. Both networks include in total around 200 centers.

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).

Вмешательства

• Диагностический тест Blood samples for analysis
  Test hormone levels in blood
• Диагностический тест Sperm samples for analysis
  Spermiogram
• Другое Satisfaction evaluation
  Participant satisfaction assessment
• Другое Quality of Life questionnaire
  The World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF)

Первичные конечные точки

• Anti-Müllerian hormone (AMH) concentration in females [Срок оценки: Change from baseline in AMH concentration at 12-15 months after the end of gonadotoxic treatment]
• Anti-Müllerian hormone (AMH) concentration in females [Срок оценки: Change in AMH concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment]
• Anti-Müllerian hormone (AMH) concentration in females [Срок оценки: Change in AMH concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment]
• Sperm concentration in males [Срок оценки: Change from baseline in sperm concentration at 12-15 months after the end of gonadotoxic treatment]
• Sperm concentration in males [Срок оценки: Change in sperm concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment]
• Sperm concentration in males [Срок оценки: Change in sperm concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment]

Вторичные конечные точки (6)

• Fertility preservation measures performed [Срок оценки: Before the start of gonadotoxic treatment]
• Satisfaction with the fertility preservation counselling before the gonadotoxic treatment [Срок оценки: 12-15 months after the end of gonadotoxic treatment]
• Satisfaction with the decision to have undergone fertility preservation measures or not [Срок оценки: 12-15 months after the end of gonadotoxic treatment]
• Number of spontaneous pregnancies and children born [Срок оценки: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment]
• Number of pregnancies and children born with the help of fertility preservation measures [Срок оценки: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment]
• Quality of life assessment [Срок оценки: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment]

Критерии участия

Критерии включения

• Patients with cancer or with benign reasons undergoing chemotherapy and/or radiotherapy of the pelvis (females) and the testicles (males) and/or immune therapy;
• 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).

Критерии исключения

• Missing consent;
• Language barrier.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 1 центр

• University Women's Hospital (Inselspital) — Bern

Публикации

• 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. PMID 38506900
• 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. PMID 38629685

Идентификаторы

NCT: NCT05885048 · KEK Bern 2022-02284 · KLS 5650-08-2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗