Sentinel Node Detection in Cervical Cancer
SLNcxca
1 other identifier
interventional
226
1 country
1
Brief Summary
Evaluation of sensitivity of Sentinel lymph nodes for detecting nodal metastases in cervical cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2014
CompletedFirst Submitted
Initial submission to the registry
September 14, 2018
CompletedFirst Posted
Study publicly available on registry
September 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedSeptember 26, 2018
September 1, 2018
6.5 years
September 14, 2018
September 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
4-5 years
Study Arms (1)
prospective cohort study
OTHERProspective 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
Interventions
The study intervention is the injection of tracer followed by detection and removal of sentinel lymph nodes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (1)
Department of Gynecology and Obstetrics
Lund, 22185, Sweden
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Persson, ass professor
Region Skane
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2018
First Posted
September 21, 2018
Study Start
June 15, 2014
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
September 26, 2018
Record last verified: 2018-09