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Sentinel Lymph Node in Early Ovarian Cancer (SENTOV)

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

Tracking Information
First Submitted Date  ICMJE February 12, 2018
First Posted Date  ICMJE March 2, 2018
Last Update Posted Date October 18, 2019
Actual Study Start Date  ICMJE March 23, 2018
Actual Primary Completion Date August 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sentinel Lymph Node in Early Ovarian Cancer
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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  ICMJE Ovarian Cancer
Intervention  ICMJE 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  ICMJE 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 21, 2019
Actual Primary Completion Date August 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03452982
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Responsible Party Instituto de Investigacion Sanitaria La Fe
Study Sponsor  ICMJE Instituto de Investigacion Sanitaria La Fe
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Victor Lago Instituto de Investigación Sanitaria La Fe
PRS Account Instituto de Investigacion Sanitaria La Fe
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP