Sentinel Lymph Node in Early Ovarian Cancer (SENTOV)

• ClinicalTrials.gov Identifier: NCT03452982
• Recruitment Status: Completed
• First Posted: March 2, 2018
• Last Update Posted: October 18, 2019
• Sponsor: Instituto de Investigacion Sanitaria La Fe
• Information provided by (Responsible Party): Instituto de Investigacion Sanitaria La Fe

Tracking Information

• First Submitted Date: February 12, 2018
• First Posted Date: March 2, 2018
• Last Update Posted Date: October 18, 2019
• Actual Study Start Date: March 23, 2018
• Actual Primary Completion Date: August 21, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 26, 2018)

Feasibility of performing the sentinel node technique (Detection rate) [ Time Frame: Intraoperative (day 0) ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 26, 2018)

• Rate of realization of the technique [ Time Frame: Intraoperative (day 0) ]
• Rate of realization of the technique [ Time Frame: After anatomopathological study (day 30) ]
• Anatomical location of the sentinel node(s) [ Time Frame: Intraoperative (day 0) ]
  Assessed by radiation (99Tc-nanocoloides) and staining with indocyanine green
• Anatomical location of the sentinel node(s) [ Time Frame: After anatomopathological study (day 30) ]
  Assessed by the pathologist
• Number of detected sentinel nodes [ Time Frame: Intraoperative (day 1) ]
• Number of detected sentinel nodes [ Time Frame: After anatomopathological study (day 30) ]
• Characterization of the sample by collecting baseline characteristics [ Time Frame: Screening (day 0) ]
  Age (years)
• Characterization of the sample by collecting baseline characteristics [ Time Frame: Screening (day 0) ]
  Weight (kilograms)
• Characterization of the sample by collecting baseline characteristics [ Time Frame: Screening (day 0) ]
  Height (centimeters)
• Characterization of the sample by collecting baseline characteristics [ Time Frame: Screening (day 0) ]
  BMI (kg/m^2)
• Characterization of the sample by collecting baseline characteristics [ Time Frame: Screening (day 0) ]
  Previous gynecological surgery and previous pathological anatomy
• Characterization of the sample by collecting tumor markers [ Time Frame: Day 0 ]
  Ca 125 and Ca 19.9.
• Characterization of the sample by collecting intraoperative findings [ Time Frame: Day 0 ]
  Ascites (milliliters)
• Characterization of the sample by collecting intraoperative findings [ Time Frame: Day 0 ]
  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 [ Time Frame: Day 0 ]
  Hysterectomy, adnexectomy, appendectomy, peritonectomy / peritoneal biopsy, omentectomy, lymphadenectomy and blood transfusion (Realized or Unrealized)
• Characterization of the sample by collecting surgical procedures [ Time Frame: Day 0 ]
  Intraoperative complications
• Characterization of the sample by collecting surgical procedures [ Time Frame: Day 0 ]
  Result of intraoperative biopsy (unrealized, malignant, benign)
• Characterization of the sample by collecting surgical procedures [ Time Frame: Day 0 ]
  Estimated blood loss (milliliters)
• Characterization of the sample by collecting surgical procedures [ Time Frame: Day 0 ]
  Surgical time (minutes)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sentinel Lymph Node in Early Ovarian Cancer
• Official Title: Sentinel Lymph Node in Early Ovarian Cancer
• 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.

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Controlled, prospective, descriptive and not randomized

Masking: None (Open Label)
Primary Purpose: Diagnostic

• Condition: Ovarian Cancer

Intervention

Other: sentinel node technique

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

Study Arms

Experimental: Patients with ovarian cancer

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

Intervention: Other: sentinel node technique

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 26, 2018): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 21, 2019
• Actual Primary Completion Date: August 21, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT03452982
• Other Study ID Numbers: SENTOV
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Instituto de Investigacion Sanitaria La Fe
• Original Responsible Party: Same as current
• Current Study Sponsor: Instituto de Investigacion Sanitaria La Fe
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Victor Lago; Instituto de Investigación Sanitaria La Fe

• PRS Account: Instituto de Investigacion Sanitaria La Fe
• Verification Date: August 2019