NCT01995591

Brief Summary

Evaluation of the possibility to detect sentinel lymph node(s) after ex vivo Indocyanine Green injections around the tumour in pieces of colectomy from patients with colon cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 12, 2016

Status Verified

June 1, 2015

Enrollment Period

1 month

First QC Date

November 20, 2013

Last Update Submit

January 11, 2016

Conditions

Colon CancerColon Surgery

Keywords

colon cancersentinel lymph nodeIndocyanine Green

Outcome Measures

Primary Outcomes (1)

  • number of sentinel lymph nodes identified in pieces of colectomy from patients with colon cancer with Indocyanine Green

    18 monthes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with colon cancer who will have colectomy

You may qualify if:

  • Patients with histo-pathological diagnosis of colon cancer who are candidate for laparoscopic colectomy,
  • Informed consent form signed.

You may not qualify if:

  • Definite lymph node metastases diagnosed either pre-operatively, or per-operatively
  • Inability to give informed consent,
  • Age \< 18 years old,
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jules Bordet Institute

Brussels, Brussels Capital, 1000, Belgium

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Gabriel Liberale, MD

    Surgeon in Jules Bordet Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2013

First Posted

November 26, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2013

Study Completion

February 1, 2015

Last Updated

January 12, 2016

Record last verified: 2015-06

Locations

BE(1)