Sentinel Lymph Node in Early Ovarian Cancer

Ovarian Cancer Clinical Trial

— SENTOV  

Official title:

Sentinel Lymph Node in Early Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452982
• Other study ID #: SENTOV
• Status: Completed
• Phase: Phase 2
• Start date: March 23, 2018
• Est. completion date: August 21, 2019

Study information

• Verified date: August 2019
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 21, 2019
• Est. primary completion date: August 21, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario y Politécnico La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigacion Sanitaria La Fe

Country where clinical trial is conducted

Spain, 

Outcome

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