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Efficacy of staging by sentinel lymph node procedure in vulvar cancer.


- candidate number1262
- NTR NumberNTR427
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested18-nov-2005
- Date Registered NTR22-aug-2005
- Secondary IDsAZR 01/095 
- Public TitleEfficacy of staging by sentinel lymph node procedure in vulvar cancer.
- Scientific TitleEfficacy of staging by sentinel lymph node procedure in vulvar cancer.
- ACRONYMN/A
- hypothesis1. Omitting complete inguinofemosal lymphadnectomy in patients with negative sentinel nodes is sufficient;
2. Morbidity associated with the sentinel node procedure is limited;
3. Frozen section, immunohistochemistry and multiple sectioning are accurate in detecting lymph node metastases.
- Healt Condition(s) or Problem(s) studiedVulvar cancer
- Inclusion criteria1. Patients with histologically proven T1 or T2 (FIGO) tumor <4 cm and not reaching urethra, vagina or anus with clinically negative inguinofemoral lymphnodes;
2. Injection of radio-isotope is possible;
3. Informed consent is possible.
- Exclusion criteria1. Inoperable tumors and tumors >4 cm;
2. Patient with chemically suspect lymph nodes or cytologically proven lymphnode metastases;
3. Multifocal tumors.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-nov-2005
- planned closingdate1-nov-2008
- Target number of participants400
- InterventionsNone: observational study.
- Primary outcomeOutcome and relapse rates in two year follow-up.
- Secondary outcomeMorbidity of the procedure and safety of frozen section multiple sectioning and immunohistochemistry in detecting lymphnode metastases.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M. Vonk
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A.G.J. Zee, van der
- Sponsor/Initiator University Hospital Groningen, Department Gynecologic Oncology
- Funding
(Source(s) of Monetary or Material Support)
CKTO, University Hospital Groningen
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD22-aug-2005 - 6-mei-2008


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