⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for External ValidatIon Trial of ASTER Trial

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: External ValidatIon Trial of ASTER Trial

Official Title: External ValidatIon Trial of Aster: the Need for Surgical Staging After Echo-endoscopic Mediastinal Staging in Clinical N2/3 Lung Cancer

Study ID: NCT01332240

Study Description

Brief Summary: As the use of endoscopic ultrasonography for mediastinal diagnosis and/or staging is widely spread in Belgium, the investigators aimed to determine the number of mediastinoscopies needed to detect one additional mediastinal lymph node invasion during routine clinical practice in the staging of potentially resectable clinical stage III non-small cell lung cancer.

Detailed Description: Background : The observation made by the ASTER investigators might be criticized as all procedures were performed in highly experienced centers. To date, the number of mediastinoscopies needed to detect one additional N2/3 disease in the routine clinical practice of chest physician performing endosonography for mediastinal staging is unknown. The investigators therefore seek to answer whether a negative endosonography should routinely be followed by mediastinoscopy in day to day clinical practice. Aim : As the use of endoscopic ultrasonography for mediastinal diagnosis and/or staging is widely spread in Belgium, the investigators aimed to determine the number of mediastinoscopies needed to detect one additional mediastinal lymph node invasion during routine clinical practice. Setting : centers in Belgium with EBUS-TBNA and/or EUS-FNA experience in at least 20 patients agreed to participate and will include their patients. Design : Prospective national observational multicenter study. All patients with clinical N2/3 disease based on CT and/or PET requiring invasive mediastinal staging will primarily undergo invasive mediastinal staging with endosonography (EBUS +/- EUS). A subsequent cervical mediastinoscopy will be performed in case no mediastinal lymph node involvement was found with endosonography. Local surgeons perform these procedures according to their institutional practice. Thoracotomy with mediastinal lymph node dissection will be the gold standard for invasive mediastinal staging, in case no mediastinal lymph node metastases were found during clinical staging including endosonography and mediastinoscopy. Patients : The study will include 255 patients, based on the calculation of 15 consecutive patients in each participating center, in order to validate the ASTER data. Primary endpoint : The number of mediastinoscopies needed to detect one additional N2/3. Secondary endpoints : The number of mediastinal lymph nodes stations sampled with endosonography ; the median size of largest mediastinal lymph node sampled; characteristics of mediastinal nodal disease missed by endosonography.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Onze Lieve Vrouw Ziekenhuis, Aalst, , Belgium

Middelheim Ziekenhuis, Antwerpen, , Belgium

Imelda ziekenhuis, Bonheiden, , Belgium

Sint-Jan Ziekenhuis Brugge, Brugge, , Belgium

Hopital Erasme Brussels, Brussels, , Belgium

Centre Hospitalier Universitaire de Charleroi, Charleroi, , Belgium

AZ Monica, Deurne, , Belgium

Universitair Ziekenhuis Antwerpen, Edegem, , Belgium

Jesse Ziekenhuis, Hasselt, , Belgium

Univeristair Ziekenhuis Brussel, Jette, , Belgium

Center Hospitalier Jolimont, La Louvière, , Belgium

UCL, Mont-Godinne, , Belgium

Hopital Sainte-Elisabeth, Namur, , Belgium

Mariaziekenhuis, Overpelt, , Belgium

Heilig Hart Ziekenhuis, Roeselare, , Belgium

Sint-Elisabeth en Sint-Jozef ziekenhuis, Turnhout, , Belgium

Sint-Augustinus ziekenhuis, Wilrijk, , Belgium

UCL Saint-Luc, Woluwe, , Belgium

Contact Details

Name: Christophe Dooms

Affiliation: Universitaire Ziekenhuizen KU Leuven

Role: PRINCIPAL_INVESTIGATOR

Name: Kurt Tournoy

Affiliation: University Hospital Ghent Belgium

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: