NCT03452982

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 ovarian-cancer

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_2 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

March 23, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2019

Completed
Last Updated

October 18, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

February 12, 2018

Last Update Submit

October 17, 2019

Conditions

Ovarian Cancer

Keywords

SENTINEL LYMPH NODE

Outcome Measures

Primary Outcomes (1)

  • Feasibility of performing the sentinel node technique (Detection rate)

    The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with previous ovarian surgery injecting the tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.

    Intraoperative (day 0)

Secondary Outcomes (19)

  • Rate of realization of the technique

    Intraoperative (day 0)

  • Rate of realization of the technique

    After anatomopathological study (day 30)

  • Anatomical location of the sentinel node(s)

    Intraoperative (day 0)

  • Anatomical location of the sentinel node(s)

    After anatomopathological study (day 30)

  • Number of detected sentinel nodes

    Intraoperative (day 1)

  • +14 more secondary outcomes

Study Arms (1)

Patients with ovarian cancer

EXPERIMENTAL

Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection

Other: sentinel node technique

Interventions

sentinel node techniqueOTHER

Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.

Patients with ovarian cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

Location

Related Publications (3)

  • 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.

    PMID: 33712275DERIVED

  • 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.

    PMID: 32448808DERIVED

  • 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.

    PMID: 31628986DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Victor Lago

    Instituto de Investigación Sanitaria La Fe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Controlled, prospective, descriptive and not randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2018

First Posted

March 2, 2018

Study Start

March 23, 2018

Primary Completion

August 21, 2019

Study Completion

August 21, 2019

Last Updated

October 18, 2019

Record last verified: 2019-08

Locations

ES(1)