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ProFertil study pro...
ProFertil study protocol for the investigation of gonadotropin-releasing hormone agonists (GnRHa) during chemotherapy aiming at fertility protection of young women and teenagers with cancer in Sweden : a phase III randomised double-blinded placebo-controlled study
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- Rodriguez-Wallberg, Kenny A. (författare)
- Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden.;Karolinska Univ Hosp, Dept Reprod Med, Stockholm, Sweden.,Department of Oncology-Pathology, Karolinska Institute, Stockholm, Sweden; Department of Reproductive Medicine, Karolinska University Hospital, Stockholm, Sweden,Department of Oncology, Norrlands University Hospital, Umeå, Sweden,Norrlands Univ Hosp, Dept Oncol, Umeå, Sweden.
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- Nilsson, Hanna Pauline (författare)
- Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden.,Department of Oncology-Pathology, Karolinska Institute, Stockholm, Sweden
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- Bergh, Jonas (författare)
- Karolinska Institutet,Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden.;Karolinska Univ Hosp, Karolinska Comprehens Canc Ctr, Stockholm, Sweden.;Univ Hosp, Stockholm, Sweden.
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- Malmros, Johan (författare)
- Pediat Theme Astrid Lindgrens Pediat Hosp, Stockholm, Sweden.,Pediatric Theme Astrid Lindgren's Pediatric Hospital, Stockholm, Sweden
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- Ljungman, Per (författare)
- Karolinska Univ Hosp, Dept Cellular Therapy & Allogene Stem Cell Transpl, Stockholm, Sweden.;Karolinska Inst, Dept Med Huddinge, Div Hematol, Huddinge, Sweden.,Department of Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska University Hospital, Stockholm, Sweden; Division of Hematology, Department of Medicine Huddinge, Karolinska Institute, Huddinge, Sweden
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- Foukakis, Theodoros (författare)
- Karolinska Institutet,Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden.;Karolinska Univ Hosp, Karolinska Comprehens Canc Ctr, Stockholm, Sweden.;Univ Hosp, Stockholm, Sweden.
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- Linder Stragliotto, Christina (författare)
- Karolinska Univ Hosp, Karolinska Comprehens Canc Ctr, Stockholm, Sweden.;Univ Hosp, Stockholm, Sweden.,Theme cancer, Karolinska Comprehensive Cancer Center and University Hospital, Stockholm, Sweden
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- Isaksson Friman, Erika (författare)
- Goran Hosp, Dept Oncol, Capio ST, Stockholm, Sweden.,Department of Oncology, Capio ST, Göran Hospital, Stockholm, Sweden
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- Linderholm, Barbro (författare)
- Sahlgrens Univ Hosp, Dept Oncol, Gothenburg, Sweden.,Department of Oncology, Sahlgrenska University Hospital, Goteborg, Sweden
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- Valachis, Antonis, 1984- (författare)
- Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Örebro Univ, Fak Med & Halsa, Oncol, Örebro, Sweden.
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- Andersson, Anne (författare)
- Norrlands Univ Hosp, Dept Oncol, Umeå, Sweden.
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- Harrysson, Sara (författare)
- Karolinska Univ Hosp, Dept Hematol, Canc Theme, Stockholm, Sweden.,Department of Hematology, Cancer Theme, Karolinska University Hospital, Stockholm, Sweden
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- Vennström, Lovisa (författare)
- Sahlgrens Univ Hosp, Dept Hematol & Coagulat, Gothenburg, Sweden.,Department of Hematology and Coagulation, Sahlgrenska University Hospital, Goteborg, Sweden
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- Frisk, Per, 1966- (författare)
- Uppsala University Hospital, Uppsala, Sweden,Akademiska Hospital, Uppsala, Sweden
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- Mörse, Helena (författare)
- Skane Univ Hosp, Ctr Pediat Oncol, Lund, Sweden.,Center for Pediatric Oncology, Skåne University Hospital, Lund, Sweden
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- Eloranta, Sandra (författare)
- Karolinska Institutet,Karolinska Inst, Dept Med, Solna, Sweden.;Karolinska Inst, Dept Med Solna, Div Clin Epidemiol, Stockholm, Sweden.
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Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden;Karolinska Univ Hosp, Dept Reprod Med, Stockholm, Sweden. Department of Oncology-Pathology, Karolinska Institute, Stockholm, Sweden; Department of Reproductive Medicine, Karolinska University Hospital, Stockholm, Sweden (creator_code:org_t)
- BMJ Publishing Group Ltd, 2023
- 2023
- Engelska.
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Ingår i: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 13:12
- Relaterad länk:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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http://kipublication...
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http://kipublication...
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Abstract
Ämnesord
Stäng
- Background Gonadotropin-releasing hormone agonists (GnRHa) cotreatment used to transiently suppress ovarian function during chemotherapy to prevent ovarian damage and preserve female fertility is used globally but efficacy is debated. Most clinical studies investigating a beneficial effect of GnRHa cotreatment on ovarian function have been small, retrospective and uncontrolled. Unblinded randomised studies on women with breast cancer have suggested a beneficial effect, but results are mixed with lack of evidence of improvement in markers of ovarian reserve. Unblinded randomised studies of women with lymphoma have not shown any benefit regarding fertility markers after long-term follow-up and no placebo-controlled study has been conducted so far. The aim of this study is to investigate if administration of GnRHa during cancer treatment can preserve fertility in young female cancer patients in a double-blind, placebo-controlled clinical trial.Methods and analysis A prospective, randomised, double-blinded, placebo-controlled, phase III study including 300 subjects with breast cancer. In addition, 200 subjects with lymphoma, acute leukemias and sarcomas will be recruited. Women aged 14–42 will be randomised 1:1 to treatment with GnRHa (triptorelin) or placebo for the duration of their gonadotoxic chemotherapy. Follow-up until 5 years from end of treatment (EoT). The primary endpoint will be change in anti-Müllerian hormone (AMH) recovery at follow-up 12 months after EoT, relative to AMH levels at EoT, comparing the GnRHa group and the placebo group in women with breast cancer.Ethics and dissemination This study is designed in accordance with the principles of Good Clinical Practice (ICH-GCP E6 (R2)), local regulations (ie, European Directive 2001/20/EC) and the ethical principles of the Declaration of Helsinki. Within 6 months of study completion, the results will be analysed and the study results shall be reported in the EudraCT database.Study registration The National Institutional review board in Sweden dnr:2021–03379, approval date 12 October 2021 (approved amendments 12 June 2022, dnr:2022-02924-02 and 13 December 2022, dnr:2022-05565-02). The Swedish Medical Product Agency 19 January 2022, Dnr:5.1-2021-98927 (approved amendment 4 February 2022). Manufacturing authorisation for authorised medicinal products approved 6 December 2021, Dnr:6.2.1-2020-079580. Stockholm Medical Biobank approved 22 June 2022, RBC dnr:202 253.Trial registration number NCT05328258; EudraCT number:2020-004780-71.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reproduktionsmedicin och gynekologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Obstetrics, Gynaecology and Reproductive Medicine (hsv//eng)
Nyckelord
- gynaecological oncology
- oncology
- reproductive medicine
- subfertility
- chemotherapy
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Rodriguez-Wallbe ...
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Nilsson, Hanna P ...
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Bergh, Jonas
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Malmros, Johan
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Ljungman, Per
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Foukakis, Theodo ...
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Linder Stragliot ...
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Isaksson Friman, ...
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Linderholm, Barb ...
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Valachis, Antoni ...
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Andersson, Anne
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Harrysson, Sara
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Vennström, Lovis ...
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Frisk, Per, 1966 ...
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Mörse, Helena
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Eloranta, Sandra
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