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Can we extend the i...
Can we extend the indication for sentinel node biopsy in vulvar cancer? A nationwide feasibility study from Sweden
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- Zach, Diana (författare)
- Karolinska Institutet,Division for Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden
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- Kannisto, Paivi (författare)
- Lund University,Lunds universitet,Obstetrik och gynekologi, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Obstetrics and Gynaecology (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine,Obstetrics and Gynecology, Clinical Sciences, Lund, Sweden
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- Stenström Bohlin, Katja (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för obstetrik och gynekologi,Institute of Clinical Sciences, Department of Obstetrics and Gynecology,Department of Obstetrics and Gynecology, University of Gothenburg Sahlgrenska Academy, Goteborg, Sweden
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- Moberg, Louise (författare)
- Lund University,Lunds universitet,Obstetrik och gynekologi, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Obstetrics and Gynaecology (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine,Obstetrics and Gynecology, Clinical Sciences, Lund, Sweden
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- Kjölhede, Preben, 1957- (författare)
- Linköpings universitet,Linköping University,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, Kvinnokliniken US
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(creator_code:org_t)
- 2019-12-02
- 2019
- Engelska.
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Ingår i: International Journal of Gynecological Cancer. - : BMJ. - 1048-891X .- 1525-1438.
- Relaterad länk:
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http://dx.doi.org/10...
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https://liu.diva-por... (primary) (Raw object)
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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http://kipublication...
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https://gup.ub.gu.se...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- Background: In squamous cell vulvar cancer, sentinel node biopsy is accepted as standard treatment in well-defined patient groups and has reduced surgical morbidity considerably. Currently, due to the lack of evidence, it cannot be offered to patients with tumors of 4 cm diameter or greater or with multifocal tumors, or in local recurrences. Primary objective: This study is primarily a pilot and feasibility trial, aiming to evaluate if the prerequisites concerning detection rate and negative predictive value are satisfactory before the implementation of a multinational trial. Study hypothesis: Sentinel node biopsy has an acceptable negative predictive value and detection rate in the study cohort. Trial design: This study is planned as a prospective, national, multicenter interventional trial. Participating patients will undergo a sentinel node biopsy in addition to an inguinofemoral lymphadenectomy. Inclusion and exclusion criteria: Inclusion criteria: for women in group 1, a primary tumor ≥4 cm in diameter; in group 2, a multifocal primary tumor; in group 3, a local recurrence without previous inguinofemoral lymphadenectomy or radiation to the groins; in group 4, a local recurrence, with previous inguinofemoral lymphadenectomy and/or radiation to the groins. Primary endpoint: The primary endpoints are the detection rate and the negative predictive value of the sentinel node procedure. Sample size: In each of the four study arms, recruitment of 20-30 patients is planned. Estimated dates for completing recruitment and presenting results: Recruitment will take place between November 2019 and October 2021. Results will be available in December 2021.
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
- sentinel lymph node
- vulvar and vaginal cancer
- vulvar and vaginal cancer; sentinel lymph node
Publikations- och innehållstyp
- art (ämneskategori)
- ref (ämneskategori)
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