Back to resultsSentinel Node Detection in Cervical Cancer (SLNcxca)
Primary Purpose
Sentinel Lymph Node Biopsy
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Sentinel node detection in cervical cancer
Sponsored by
About this trial
This is an interventional diagnostic trial for Sentinel Lymph Node Biopsy
Eligibility Criteria
Inclusion Criteria:
- Women of age 18 years and older at the time of informed consent.
- Women with a pathologically proven cervical carcinoma of any histologic subtype, clinically stage 1a2- 2a1 planned for primary surgery
- Absence of any exclusion criteria
Exclusion Criteria:
- Non consenting patients
- Ongoing pregnancy
- Inability to understand written and/or oral study information
- Who performance status III or more
- Previous lower limb lymphedema
- Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.
- Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion
- Locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography
- Radiologically suspect pelvic nodal metastatic disease according to the RECIST criteria (>= 1 node with >=16 mm short axis diameter)
- Allergy to Iodine
- Patients with a known liver disease
- Patients with a significant bleeding disorder or mandatory antithrombotic treatment.
Sites / Locations
- Department of Gynecology and ObstetricsRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
prospective cohort study
Arm Description
Prospective cohort study with detection of sentinel lymph nodes followed by a full pelvic lymphadenectomy. Patients will act as their own controls. The intervention is the detection and removal of sentinel lymph nodes
Outcomes
Primary Outcome Measures
Sentinel node detection in cervical cancer; Sensitivity and negative predictive values for identifying pelvic nodal disease, See detailed study protocol
Detection of Sentinel nodes followed by full pelvic lymphadenectomy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03680833
Brief Title
Sentinel Node Detection in Cervical Cancer
Acronym
SLNcxca
Official Title
Sentinel Node Detection in Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2014 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation of sensitivity of Sentinel lymph nodes for detecting nodal metastases in cervical cancer
Detailed Description
Consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached for eligibility by defined criteria.
Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers.
Technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated.
An interim analyse will be performed after 34 node positive patients based on the Fleming two stage analyse. The null hypothesis of sensitivity of 85% will be tested against an estimated sensitivity of 95%. At this stage the study may be closed for futility, closed as hull hypothesis is rejected or continued to reach another 28 node positive patients.
As a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient will act ast their own controls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sentinel Lymph Node Biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
226 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
prospective cohort study
Arm Type
Other
Arm Description
Prospective cohort study with detection of sentinel lymph nodes followed by a full pelvic lymphadenectomy. Patients will act as their own controls.
The intervention is the detection and removal of sentinel lymph nodes
Intervention Type
Procedure
Intervention Name(s)
Sentinel node detection in cervical cancer
Intervention Description
The study intervention is the injection of tracer followed by detection and removal of sentinel lymph nodes
Primary Outcome Measure Information:
Title
Sentinel node detection in cervical cancer; Sensitivity and negative predictive values for identifying pelvic nodal disease, See detailed study protocol
Description
Detection of Sentinel nodes followed by full pelvic lymphadenectomy
Time Frame
4-5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women of age 18 years and older at the time of informed consent.
Women with a pathologically proven cervical carcinoma of any histologic subtype, clinically stage 1a2- 2a1 planned for primary surgery
Absence of any exclusion criteria
Exclusion Criteria:
Non consenting patients
Ongoing pregnancy
Inability to understand written and/or oral study information
Who performance status III or more
Previous lower limb lymphedema
Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.
Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion
Locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography
Radiologically suspect pelvic nodal metastatic disease according to the RECIST criteria (>= 1 node with >=16 mm short axis diameter)
Allergy to Iodine
Patients with a known liver disease
Patients with a significant bleeding disorder or mandatory antithrombotic treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Persson, ass professor
Phone
+46733522080
Email
jan.persson@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Linnea Ekdahl, MD
Phone
0739292631
Email
linnea.ekdahl@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Persson, ass professor
Organizational Affiliation
Region Skane
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gynecology and Obstetrics
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Persson, ass professor
Phone
+46733522080
Email
jan.persson@med.lu.se
First Name & Middle Initial & Last Name & Degree
Linnea Ekdahl, MD
Phone
+46739292631
Email
linnea.ekdahl@med.lu.se
12. IPD Sharing Statement
Learn more about this trial
Sentinel Node Detection in Cervical Cancer
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