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

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ClinicalTrials.gov Identifier: NCT01329575
Recruitment Status : Active, not recruiting
First Posted : April 6, 2011
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Neoplasm of Mediastinal Lymph Nodes

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Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Malignancy Using Endoluminal Ultrasound Characteristics in Mediastinal Lymph Nodes
Study Start Date : January 2011
Primary Completion Date : December 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329575


Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
Principal Investigator: Moishe Liberman, MD, PhD Centre hospitalier de l'Université de Montréal (CHUM)
More Information

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01329575     History of Changes
Other Study ID Numbers: CE 11.005
First Posted: April 6, 2011    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

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