Predicting Malignancy Using Endoluminal Ultrasound Characteristics in Mediastinal Lymph Nodes (CT0024)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Collaborators:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
C.E.T.O.C. CHUM Endoscopic Tracheo-Bronchial and Oesophageal Center
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01329575
First received: April 4, 2011
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

There is no single method to investigate mediastinal LN invasion. Hence, a patient may have to undergo several tests and procedures. Noninvasive and invasive approaches are employed. Within the invasive techniques, endoscopic ultrasonography with needle aspiration (EUS-FNA) and endobronchial ultrasonography with transbronchial needle aspiration (EBUS-TBNA) are gaining importance in mediastinal staging.5 They provide ultrasonographic images and permit needle aspiration under direct vision for cytology specimen analysis. As more evidence is being accumulated on these staging approaches, the number of cervical mediastinoscopies, considered as the gold-standard for mediastinal staging, is diminishing.

Color Doppler LN characteristics with endoluminal ultrasound (US) is only mentioned in a small number of studies and needs to be further investigated.13,14 With the good results obtained with superficial US, it seems reasonable to believe that color Doppler characteristics would increase accuracy in detecting malignancy of mediastinal LNs with endoluminal US.


Condition
Neoplasm of Mediastinal Lymph Nodes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Malignancy Using Endoluminal Ultrasound Characteristics in Mediastinal Lymph Nodes

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • With a combination of endoluminal ultrasound characteristics, a simple scoring system can be established to help predict malignancy in mediastinal lymph nodes. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    collected characteristics univariate and multivariate logistic regressions will be used to establish a scoring system to predict malignancy. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy will be determined based on the developed model.


Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • Patients undergoing EUS-FNA and/or EBUS-TBNA for mediastinal LN assessment

Exclusion Criteria:

  • Age < 18 years old
  • Inability to consent to the study
  • Medications including Warfarin (Coumadin) or Clopidogrel (Plavix)
  • Coagulopathy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329575

Contacts
Contact: Vicky Thiffault, RN, CCRP 514-890-8000 ext 23432 vicky.thiffault.chum@ssss.gouv.qc.ca

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Vicky Thiffault, RN, CCRP    514-890-8000 ext 23432    vicky.thiffault.chum@ssss.gouv.qc.ca   
Principal Investigator: Moishe Liberman, MD, PhD         
Sub-Investigator: Pasquale Ferraro, MD         
Sub-Investigator: André Duranceau, MD         
Sub-Investigator: Jocelyne Martin, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
C.E.T.O.C. CHUM Endoscopic Tracheo-Bronchial and Oesophageal Center
Investigators
Principal Investigator: Moishe Liberman, MD, PhD Centre Hospitalier de l'Université de Montréal
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01329575     History of Changes
Other Study ID Numbers: CE 11.005
Study First Received: April 4, 2011
Last Updated: February 11, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
endoluminal ultrasound
Mediastinal LN invasion

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 11, 2014