Sentinel Lymph Node Assessment in Ovarian Cancer (TRSGO-SLN-OO5)

NCT04714931 | Unknown

• 1 other identifier: TRSGO-SLN-OO5
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study to evaluate the feasibility and accuracy of sentinel lymph node technique in ovarian cancer.

Conditions

Ovarian Cancer; Sentinel Lymph Node

Outcome Measures

Primary Outcomes (5)

• Sentinel lymph node localization

  Localization areas of pelvic and paraaortic sentinel lymph nodes for ovarian cancer will be identified.

  12 months

• Sentinel lymph node technique accuracy in ovarian cancer

  Sensitivity and specificity measure of the sentinel lymph node procedure in ovarian cancer for detecting the lymphatic metastasis

  12 months

• PPV and NPV of sentinel lymph node procedure in ovarian cancer

  Positive predictive and negative predictive value of sentinel lymph node procedure in ovarian cancer.

  12 months

• Adverse events

  Adverse events related with sentinel lymph node procedure in ovarian cancer

  12 months

• Sentinel lymph node detection rate

  Pelvic and paraaortic Sentinel lymph node detection rates will be assessed for ovarian cancer.

  12 months

Secondary Outcomes (2)

• Tracer comparisons

  12 months

• Assessment of the sentinel tecniques

  12 months

Study Arms (1)

Sentinel Lymph Node

OTHER

Sentinel lymph nodes which can be identified with the tracer involvement will be removed. Then, systematic lymphadenectomy will be performed according to the routine practice.

Diagnostic Test: Sentinel lymph node detection

Interventions

Sentinel lymph node detection DIAGNOSTIC_TEST

Tracer (Indocyanine green or blue dye) will be injected into the IP and utero-ovarian ligaments, after opening of the pelvic and paraaortic retroperitoneal spaces, sentinel lymph nodes which can be identified with the tracer involvement will be removed. Then, systematic lymphadenectomy will be performed according to the routine practice.

Sentinel Lymph Node

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Early stage ovarian cancer

You may not qualify if:

• Patient who had been administrated chemotherapy prior to surgery
• Patients who had diagnosed with malignancy other than ovarian cancer.
• Patients who had undergone pelvic or paraaortic lymphadenectomy or surgery prior to surgery.
• Patients who have allergy for the tracers.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem MAA University Maslak Hospital

Istanbul, 34457, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Mete Gungor, Prof.

  Acibadem MAA University Maslak Hospital

  STUDY DIRECTOR

Central Study Contacts

Ozguc Takmaz, Assist.Prof

CONTACT

+905554006591; ozguctakmaz@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,Assistant Professor

Model Details: Prospective, Controlled, not randomized

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 20, 2021
• Study Start: January 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

TU (1)