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Sentinel Lymph Node in Early Ovarian Cancer (SENTOV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Other: sentinel node technique Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Controlled, prospective, descriptive and not randomized
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sentinel Lymph Node in Early Ovarian Cancer
Actual Study Start Date : March 23, 2018
Actual Primary Completion Date : August 21, 2019
Actual Study Completion Date : August 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with ovarian cancer
Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection
 Other: sentinel node technique
Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rate of realization of the technique [ Time Frame: Intraoperative (day 0) ]
  2. Rate of realization of the technique [ Time Frame: After anatomopathological study (day 30) ]
  3. Anatomical location of the sentinel node(s) [ Time Frame: Intraoperative (day 0) ]
    Assessed by radiation (99Tc-nanocoloides) and staining with indocyanine green

  4. Anatomical location of the sentinel node(s) [ Time Frame: After anatomopathological study (day 30) ]
    Assessed by the pathologist

  5. Number of detected sentinel nodes [ Time Frame: Intraoperative (day 1) ]
  6. Number of detected sentinel nodes [ Time Frame: After anatomopathological study (day 30) ]
  7. Characterization of the sample by collecting baseline characteristics [ Time Frame: Screening (day 0) ]
    Age (years)

  8. Characterization of the sample by collecting baseline characteristics [ Time Frame: Screening (day 0) ]
    Weight (kilograms)

  9. Characterization of the sample by collecting baseline characteristics [ Time Frame: Screening (day 0) ]
    Height (centimeters)

  10. Characterization of the sample by collecting baseline characteristics [ Time Frame: Screening (day 0) ]
    BMI (kg/m^2)

  11. Characterization of the sample by collecting baseline characteristics [ Time Frame: Screening (day 0) ]
    Previous gynecological surgery and previous pathological anatomy

  12. Characterization of the sample by collecting tumor markers [ Time Frame: Day 0 ]
    Ca 125 and Ca 19.9.

  13. Characterization of the sample by collecting intraoperative findings [ Time Frame: Day 0 ]
    Ascites (milliliters)

  14. 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.

  15. 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)

  16. Characterization of the sample by collecting surgical procedures [ Time Frame: Day 0 ]
    Intraoperative complications

  17. Characterization of the sample by collecting surgical procedures [ Time Frame: Day 0 ]
    Result of intraoperative biopsy (unrealized, malignant, benign)

  18. Characterization of the sample by collecting surgical procedures [ Time Frame: Day 0 ]
    Estimated blood loss (milliliters)

  19. Characterization of the sample by collecting surgical procedures [ Time Frame: Day 0 ]
    Surgical time (minutes)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452982


Locations
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Spain
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
Investigators
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Principal Investigator: Victor Lago Instituto de Investigación Sanitaria La Fe
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT03452982    
Other Study ID Numbers: SENTOV
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Investigacion Sanitaria La Fe:
SENTINEL LYMPH NODE
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type