To Assess and Compare the Performance Two Approach for Sentinel Lymph Node (SNLD) Biopsy for Endometrial Cancer

August 13, 2020 updated by: Cihan Comba, Haseki Training and Research Hospital

Endometrium Kanseri Nedeniyle Opere Olacak hastaların Sentinel Lenf Nodu Diseksiyonu değerlendirilirken kullanılan Iki farklı yöntemin kıyaslaması

to assess and compare the performance two approaches for sentinel lymph node ( SLND) biopsy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Endometrial cancer is the most common gynecologic cancer. Most patients diagnosed in early stages because cancer causes remarkable symptoms such as postmenopausal or abnormal bleeding. Mostly, it does not spread, detects no metastasis. Endometrial carcinoma is surgically staged. Laparotomy or minimally invasive surgery can be performed for treatment and staging. Patients have been operated for staging surgery, have a larger surgical incision, longer operation period, more complications, more intensive care units need. Nowadays, researchers show us that there is no difference in overall survival and prognosis between surgery with or without lymphadenectomy in endometrial cancer. With all these improvements in gynecologic oncology leads us to minimally invasive surgery. Patients undergo sentinel lymph node detection by using fluorescence imaging with an indocyanine green solution. Two different ways used to assess SLND. The first group who the cervix is injected superficially with 1 mL of ICG ( indocyanine green) at 4 and 8 o'clock quadrans. The second group who ICG has injected the uterine cavity during hysteroscopy. The investigator's aim is to assess and compare the performance of two approaches for sentinel lymph node ( SLND) biopsy.

Study Type

Observational

Enrollment (Anticipated)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

patients who have experienced endometrial cancer surgery

Description

Inclusion Criteria:

  • The patient must be willing and able to provide informed consent
  • The patient is willing and able to comply with the study protocol
  • The patient has endometrial cancer and is performed SLND
  • The patient agrees to follow-up examination out to 5-years post-treatment

Exclusion Criteria:

  • The patient is not a candidate for surgery
  • The patient has metastasis
  • The patient has known or suspected allergies to iodine, indocyanine green( ICG)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
assesment SLND with enjection by using ICG
Patients who have endometrium cancer; undergo sentinel lymph node detection by using fluorescence imaging with an indocyanine green solution. Two different ways used to assess SLND. The first group in which the cervix is injected superficially with 1 mL of ICG ( indocyanine green) at 4 and 8 o'clock quadrans.
Drug: Indocyanine green solution
Indocyanine green (ICG) is a cyanine dye used in medical diagnostics.ICG is a fluorescent dye that is used in medicine as an indicator substance.
Other Names:
  • No indocyanine green solution
assesment SLND with hysterescopy by using ICG
Patients who have endometrium cancer; undergo sentinel lymph node detection by using fluorescence imaging with an indocyanine green solution. Two different ways used to assess SLND. The second one which ICG has injected the uterine cavity during hysteroscopy. Our aim is to assess and compare the performance two approaches for sentinel lymph node ( SLND) biopsy.
Drug: Indocyanine green solution
Indocyanine green (ICG) is a cyanine dye used in medical diagnostics.ICG is a fluorescent dye that is used in medicine as an indicator substance.
Other Names:
  • No indocyanine green solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SLN detecting rate
Time Frame: 1 year
SLN is the first lymph node to spread tumoral cells.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Overall survival of endometrial cancer measures as five years
5 years
Disease free survival
Time Frame: 5 years
Disease free survival can be describe with no tumor occurance after surgery
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haseki Training and Research Hospital

Investigators

  • Study Chair: Cihan Comba, M.D., Sultangazi Haseki Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

August 30, 2021

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

August 13, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2020

Last Update Submitted That Met QC Criteria

August 13, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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