Clinical trial NCT03452982: Sentinel Lymph Node in Early Ovarian Cancer
Official title: Sentinel Lymph Node in Early Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: SENTINEL LYMPH NODE
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Controlled, prospective, descriptive and not randomized
Primary purpose: DIAGNOSTIC

Brief summary: This research study evaluates the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.

Detailed description: The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with early stage ovarian cancer.

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.

Eligibility criteria: Inclusion Criteria:

* Informed consent signed previously to performing any procedure related to the clinical trial.
* 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:

* Informed consent not obtained or withdraw.
* 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

Primary outcomes:
measure: Feasibility of performing the sentinel node technique (Detection rate)
timeFrame: Intraoperative (day 0)
Secondary outcomes:
measure: Rate of realization of the technique
timeFrame: Intraoperative (day 0)
measure: Rate of realization of the technique
timeFrame: After anatomopathological study (day 30)
measure: Anatomical location of the sentinel node(s)
timeFrame: Intraoperative (day 0)
measure: Anatomical location of the sentinel node(s)
timeFrame: After anatomopathological study (day 30)
measure: Number of detected sentinel nodes
timeFrame: Intraoperative (day 1)
measure: Number of detected sentinel nodes
timeFrame: After anatomopathological study (day 30)
measure: Characterization of the sample by collecting baseline characteristics
timeFrame: Screening (day 0)
measure: Characterization of the sample by collecting baseline characteristics
timeFrame: Screening (day 0)
measure: Characterization of the sample by collecting baseline characteristics
timeFrame: Screening (day 0)
measure: Characterization of the sample by collecting baseline characteristics
timeFrame: Screening (day 0)
measure: Characterization of the sample by collecting baseline characteristics
timeFrame: Screening (day 0)
measure: Characterization of the sample by collecting tumor markers
timeFrame: Day 0
measure: Characterization of the sample by collecting intraoperative findings
timeFrame: Day 0
measure: Characterization of the sample by collecting intraoperative findings
timeFrame: Day 0
measure: Characterization of the sample by collecting surgical procedures
timeFrame: Day 0
measure: Characterization of the sample by collecting surgical procedures
timeFrame: Day 0
measure: Characterization of the sample by collecting surgical procedures
timeFrame: Day 0
measure: Characterization of the sample by collecting surgical procedures
timeFrame: Day 0
measure: Characterization of the sample by collecting surgical procedures
timeFrame: Day 0
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
affiliation: Instituto de Investigación Sanitaria La Fe
name: Victor Lago
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.