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Sentinel Lymph Node in Early Ovarian Cancer (SENTOV)

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
sentinel node technique
Sponsored by
Instituto de Investigacion Sanitaria La Fe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Cancer focused on measuring SENTINEL LYMPH NODE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario y Politécnico La Fe

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with ovarian cancer

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of realization of the technique
Rate of realization of the technique
Anatomical location of the sentinel node(s)
Assessed by radiation (99Tc-nanocoloides) and staining with indocyanine green
Anatomical location of the sentinel node(s)
Assessed by the pathologist
Number of detected sentinel nodes
Number of detected sentinel nodes
Characterization of the sample by collecting baseline characteristics
Age (years)
Characterization of the sample by collecting baseline characteristics
Weight (kilograms)
Characterization of the sample by collecting baseline characteristics
Height (centimeters)
Characterization of the sample by collecting baseline characteristics
BMI (kg/m^2)
Characterization of the sample by collecting baseline characteristics
Previous gynecological surgery and previous pathological anatomy
Characterization of the sample by collecting tumor markers
Ca 125 and Ca 19.9.
Characterization of the sample by collecting intraoperative findings
Ascites (milliliters)
Characterization of the sample by collecting intraoperative findings
Tumor size (centimeters) of: right ovary, left ovary, right tube, left tube, uterus, pelvic nodes, para-aortic nodes, and tumor in upper hemiabdomen.
Characterization of the sample by collecting surgical procedures
Hysterectomy, adnexectomy, appendectomy, peritonectomy / peritoneal biopsy, omentectomy, lymphadenectomy and blood transfusion (Realized or Unrealized)
Characterization of the sample by collecting surgical procedures
Intraoperative complications
Characterization of the sample by collecting surgical procedures
Result of intraoperative biopsy (unrealized, malignant, benign)
Characterization of the sample by collecting surgical procedures
Estimated blood loss (milliliters)
Characterization of the sample by collecting surgical procedures
Surgical time (minutes)

Full Information

First Posted
February 12, 2018
Last Updated
October 17, 2019
Sponsor
Instituto de Investigacion Sanitaria La Fe
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1. Study Identification

Unique Protocol Identification Number
NCT03452982
Brief Title
Sentinel Lymph Node in Early Ovarian Cancer
Acronym
SENTOV
Official Title
Sentinel Lymph Node in Early Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 23, 2018 (Actual)
Primary Completion Date
August 21, 2019 (Actual)
Study Completion Date
August 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigacion Sanitaria La Fe

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
SENTINEL LYMPH NODE

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Controlled, prospective, descriptive and not randomized
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with ovarian cancer
Arm Type
Experimental
Arm Description
Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection
Intervention Type
Other
Intervention Name(s)
sentinel node technique
Intervention Description
Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.
Primary Outcome Measure Information:
Title
Feasibility of performing the sentinel node technique (Detection rate)
Description
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.
Time Frame
Intraoperative (day 0)
Secondary Outcome Measure Information:
Title
Rate of realization of the technique
Time Frame
Intraoperative (day 0)
Title
Rate of realization of the technique
Time Frame
After anatomopathological study (day 30)
Title
Anatomical location of the sentinel node(s)
Description
Assessed by radiation (99Tc-nanocoloides) and staining with indocyanine green
Time Frame
Intraoperative (day 0)
Title
Anatomical location of the sentinel node(s)
Description
Assessed by the pathologist
Time Frame
After anatomopathological study (day 30)
Title
Number of detected sentinel nodes
Time Frame
Intraoperative (day 1)
Title
Number of detected sentinel nodes
Time Frame
After anatomopathological study (day 30)
Title
Characterization of the sample by collecting baseline characteristics
Description
Age (years)
Time Frame
Screening (day 0)
Title
Characterization of the sample by collecting baseline characteristics
Description
Weight (kilograms)
Time Frame
Screening (day 0)
Title
Characterization of the sample by collecting baseline characteristics
Description
Height (centimeters)
Time Frame
Screening (day 0)
Title
Characterization of the sample by collecting baseline characteristics
Description
BMI (kg/m^2)
Time Frame
Screening (day 0)
Title
Characterization of the sample by collecting baseline characteristics
Description
Previous gynecological surgery and previous pathological anatomy
Time Frame
Screening (day 0)
Title
Characterization of the sample by collecting tumor markers
Description
Ca 125 and Ca 19.9.
Time Frame
Day 0
Title
Characterization of the sample by collecting intraoperative findings
Description
Ascites (milliliters)
Time Frame
Day 0
Title
Characterization of the sample by collecting intraoperative findings
Description
Tumor size (centimeters) of: right ovary, left ovary, right tube, left tube, uterus, pelvic nodes, para-aortic nodes, and tumor in upper hemiabdomen.
Time Frame
Day 0
Title
Characterization of the sample by collecting surgical procedures
Description
Hysterectomy, adnexectomy, appendectomy, peritonectomy / peritoneal biopsy, omentectomy, lymphadenectomy and blood transfusion (Realized or Unrealized)
Time Frame
Day 0
Title
Characterization of the sample by collecting surgical procedures
Description
Intraoperative complications
Time Frame
Day 0
Title
Characterization of the sample by collecting surgical procedures
Description
Result of intraoperative biopsy (unrealized, malignant, benign)
Time Frame
Day 0
Title
Characterization of the sample by collecting surgical procedures
Description
Estimated blood loss (milliliters)
Time Frame
Day 0
Title
Characterization of the sample by collecting surgical procedures
Description
Surgical time (minutes)
Time Frame
Day 0

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Lago
Organizational Affiliation
Instituto de Investigación Sanitaria La Fe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario y Politécnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33712275
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.
Results Reference
derived
PubMed Identifier
32448808
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.
Results Reference
derived
PubMed Identifier
31628986
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.
Results Reference
derived

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Sentinel Lymph Node in Early Ovarian Cancer

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