Predicting Malignancy Using Endoluminal Ultrasound Characteristics in Mediastinal Lymph Nodes (CT0024)
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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 |
- 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 2013 |
| Estimated Primary Completion Date: | December 2013 (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 |
Primary care clinic
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| Contact: Vicky Thiffault, RN, CCRP | 514-890-8000 ext 23432 | vicky.thiffault.chum@ssss.gouv.qc.ca |
| 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 | |
| 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: | June 3, 2013 |
| 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 June 17, 2013