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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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2018-03-23
2019-08-21
Brief Summary
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Detailed Description
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With this research study it will be evaluated the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients with ovarian cancer
Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection
sentinel node technique
Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.
Interventions
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sentinel node technique
Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.
Eligibility Criteria
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Inclusion Criteria
* Patients who are women 18 years of age or older at the moment of the randomization.
* Patients with anatomopathological diagnosis of malignant ovarian tumor in a deferred study proposals for staging surgery or patients with suspicious tumor of malignancy who are going to be subjected to exploratory lapaotomy or laparoscopy and operative biopsy, and in the case this is positive, surgery of staging will be performed .
Exclusion Criteria
* Benign result in extemporaneous study
* Previous history of vascular surgery in the aorta, cava or pelvic vessels
* Previous pelvic or para-aortic lymphadenectomy
* Previous lymphoma
* Previous abdomino-pelvic tumor
* Previous allergic reaction to indocyanine green
* Pregnancy / lactation
* Severe adherent syndrome
18 Years
FEMALE
No
Sponsors
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Instituto de Investigacion Sanitaria La Fe
OTHER
Responsible Party
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Principal Investigators
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Victor Lago
Role: PRINCIPAL_INVESTIGATOR
Instituto de Investigación Sanitaria La Fe
Locations
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Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Countries
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References
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Lago V, Montero B, Lopez S, Padilla-Iserte P, Matute L, Marina T, Gurrea M, Montoliu G, Bello P, Domingo S. Ultrastaging protocol in sentinel lymph node for apparent early stage ovarian cancer. Gynecol Oncol. 2021 May;161(2):408-413. doi: 10.1016/j.ygyno.2021.03.001. Epub 2021 Mar 10.
Lago V, Bello P, Montero B, Matute L, Padilla-Iserte P, Lopez S, Marina T, Agudelo M, Domingo S. Sentinel lymph node technique in early-stage ovarian cancer (SENTOV): a phase II clinical trial. Int J Gynecol Cancer. 2020 Sep;30(9):1390-1396. doi: 10.1136/ijgc-2020-001289. Epub 2020 May 23.
Lago V, Bello P, Matute L, Padilla-Iserte P, Marina T, Agudelo M, Domingo S. Sentinel Lymph Node Technique in Apparent Early Ovarian Cancer: Laparoscopic Technique. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1019-1020. doi: 10.1016/j.jmig.2019.09.790. Epub 2019 Oct 16.
Other Identifiers
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SENTOV
Identifier Type: -
Identifier Source: org_study_id
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