Loading search results
Confocal Laser Endomicroscopy as Diagnostic Tool for Gastrointestinal MALT-lymphoma
Sponsor study identifier
interventional
50
1 country
1
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2014
Actual (reported)Study Completion
March 2014
Actual (reported)Extranodal marginal zone B-cell lymphoma (MZBL) of the mucosa associated lymphoid tissue (MALT-lymphoma) represents a distinct clinical entity and is the most common form of extranodal lymphoma, with a predilection for the stomach. About 90% of gastric MALT-lymphomas are associated with infection with Helicobacter pylori (HP) and eradication of the pathogen leads to regression of the tumor in a high percentage of patients at early tumour stages. Nevertheless, following complete remission after HP-eradication, the risk of relapse justifies lifelong follow-up examinations. Supported by recent findings at the investigators department, endoscopic controls should include a close examination of the small bowel, as relapses can involve different gastrointestinal sites. To continue the investigators diagnostic approach as well as to further improve the detection rate of MALT-lymphoma relapses, the investigators plan to introduce the novel confocal laser endomicroscope (CLE) into the diagnostic management of MALT-lymphoma patients. In the context of a prospective clinical pilot trial the investigators aim to establish MALT-lymphoma specific CLE-markers that can be used for the in vivo diagnosis of the disease. Comparing endomicroscopic findings, drawn from the stomach and small bowel of 50 MALT-lymphoma patients who will undergo staging or follow up endoscopies at the investigators department, to the histological evaluation of biopsy samples as present gold standard, the investigators want to determine whether CLE can provide reliable data for the accurate detection of MALT-lymphoma associated changes. Endomicroscopic aspects of patients with chronic gastritis, gastric adenocarcinoma and healthy subjects should serve as controls. In comparison to random biopsies which represent the current standard, the investigators aim to prove, whether endomicroscopy will find MALT-lymphoma lesions more accurately and thus help to spare patients unnecessary biopsies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 8, 2012
Actual (reported)April 2012
Date type not reportedThis date has not been verified as actual or estimated.
April 24, 2012
Actual (reported)March 2014
Actual (reported)March 2014
Actual (reported)Qualitative MALT-features on Endomicroscopy
Establishing endomicroscopic features of MALT-lymphoma in the upper gastrointestinal tract. This outcome is a qualitative endpoint that will be assessed only descriptively.
2 years
Sensitivity and Specificity of Endomicroscopy to diagnose GI-MALT-Lymphoma
2 years
All patients included into the study will undergo endomicroscopy of the upper GI-tract.
Endomicroscopy of the upper gastrointestinal tract to capture endomicroscopic pictures from the small bowel, stomach and esophagus.
Pentax EC-3870 CIFK with the ISC-1000 confocal endomicroscopy processor - Pentax, Tokyo, Japan and Optiscan Pty Ltd, Notting Hill, Victoria, Australia
Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology
Vienna, Austria
Ott G, Balague-Ponz O, de Leval L, de Jong D, Hasserjian RP, Elenitoba-Johnson KS. Commentary on the WHO classification of tumors of lymphoid tissues (2008): indolent B cell lymphomas. J Hematop. 2009 Jul;2(2):77-81. doi: 10.1007/s12308-009-0037-9. Epub 2009 Jun 25.
Ferreri AJ, Zucca E. Marginal-zone lymphoma. Crit Rev Oncol Hematol. 2007 Sep;63(3):245-56. doi: 10.1016/j.critrevonc.2007.04.009. Epub 2007 Jun 20.
Werner Dolak, MD
Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterologie and Hepatologie
Andreas Puespoek, m
Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology
Markus Raderer, MD
Medical University of Vienna, Department of Internal Medicine I, Division of Oncology
First Submitted
January 8, 2012
First Posted
April 24, 2012
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2014
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Morgner A, Schmelz R, Thiede C, Stolte M, Miehlke S. Therapy of gastric mucosa associated lymphoid tissue lymphoma. World J Gastroenterol. 2007 Jul 14;13(26):3554-66. doi: 10.3748/wjg.v13.i26.3554.
Zullo A, Hassan C, Andriani A, Cristofari F, De Francesco V, Ierardi E, Tomao S, Morini S, Vaira D. Eradication therapy for Helicobacter pylori in patients with gastric MALT lymphoma: a pooled data analysis. Am J Gastroenterol. 2009 Aug;104(8):1932-7; quiz 1938. doi: 10.1038/ajg.2009.314. Epub 2009 Jun 16.
Terai S, Iijima K, Kato K, Dairaku N, Suzuki T, Yoshida M, Koike T, Kitagawa Y, Imatani A, Sekine H, Ohara S, Shimosegawa T. Long-term outcomes of gastric mucosa-associated lymphoid tissue lymphomas after Helicobacter pylori eradication therapy. Tohoku J Exp Med. 2008 Jan;214(1):79-87. doi: 10.1620/tjem.214.79.
Raderer M, Isaacson PG. Extranodal lymphoma of MALT-type: perspective at the beginning of the 21st century. Expert Rev Anticancer Ther. 2001 Jun;1(1):53-64. doi: 10.1586/14737140.1.1.53.
Raderer M, Streubel B, Woehrer S, Puespoek A, Jaeger U, Formanek M, Chott A. High relapse rate in patients with MALT lymphoma warrants lifelong follow-up. Clin Cancer Res. 2005 May 1;11(9):3349-52. doi: 10.1158/1078-0432.CCR-04-2282.
Isaacson PG. Gastric MALT lymphoma: from concept to cure. Ann Oncol. 1999 Jun;10(6):637-45. doi: 10.1023/a:1008396618983.
Dolak W, Raderer M, Maresch J, Muellauer L, Puespoek A, Chott A, Haefner M. Detection of gastric MALT lymphoma spreading to the small bowel by enteroscopy. Endoscopy. 2011 Aug;43(8):731-3. doi: 10.1055/s-0030-1256435. Epub 2011 Jun 7.
Hyatt BJ, Paull PE, Wassef W. Gastric oncology: an update. Curr Opin Gastroenterol. 2009 Nov;25(6):570-8. doi: 10.1097/MOG.0b013e328331b5c9.
Puspok A, Raderer M, Chott A, Dragosics B, Gangl A, Schofl R. Endoscopic ultrasound in the follow up and response assessment of patients with primary gastric lymphoma. Gut. 2002 Nov;51(5):691-4. doi: 10.1136/gut.51.5.691.
Al-Taie OH, Dietrich CF, Dietrich CG, Fischbach W. [Role of endoscopic ultrasound in gastrointestinal lymphomas]. Z Gastroenterol. 2008 Jun;46(6):618-24. doi: 10.1055/s-2008-1027517. German.
Kiesslich R, Galle P, Neurath M. Atlas of endomicroscopy. Springer Medical Publishing. 2008
Kiesslich R, Goetz M, Burg J, Stolte M, Siegel E, Maeurer MJ, Thomas S, Strand D, Galle PR, Neurath MF. Diagnosing Helicobacter pylori in vivo by confocal laser endoscopy. Gastroenterology. 2005 Jun;128(7):2119-23. doi: 10.1053/j.gastro.2004.12.035.
Dolak W, Leitner J, Maresch J, Wrba F, Mueller C. In vivo identification by confocal laser endoscopy of foamy macrophages associated with Whipple's disease. Endoscopy. 2010;42 Suppl 2:E310-1. doi: 10.1055/s-0030-1255809. Epub 2010 Nov 26. No abstract available.
Kiesslich R, Gossner L, Goetz M, Dahlmann A, Vieth M, Stolte M, Hoffman A, Jung M, Nafe B, Galle PR, Neurath MF. In vivo histology of Barrett's esophagus and associated neoplasia by confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2006 Aug;4(8):979-87. doi: 10.1016/j.cgh.2006.05.010. Epub 2006 Jul 13.
Dunbar KB, Okolo P 3rd, Montgomery E, Canto MI. Confocal laser endomicroscopy in Barrett's esophagus and endoscopically inapparent Barrett's neoplasia: a prospective, randomized, double-blind, controlled, crossover trial. Gastrointest Endosc. 2009 Oct;70(4):645-54. doi: 10.1016/j.gie.2009.02.009. Epub 2009 Jun 25.
Kiesslich R, Goetz M, Lammersdorf K, Schneider C, Burg J, Stolte M, Vieth M, Nafe B, Galle PR, Neurath MF. Chromoscopy-guided endomicroscopy increases the diagnostic yield of intraepithelial neoplasia in ulcerative colitis. Gastroenterology. 2007 Mar;132(3):874-82. doi: 10.1053/j.gastro.2007.01.048. Epub 2007 Jan 31.
Dolak W, Kiesewetter B, Mullauer L, Mayerhoefer M, Troch M, Trauner M, Hafner M, Raderer M, Puspok A. A pilot study of confocal laser endomicroscopy for diagnosing gastrointestinal mucosa-associated lymphoid tissue (MALT) lymphoma. Surg Endosc. 2016 Jul;30(7):2879-85. doi: 10.1007/s00464-015-4572-4. Epub 2015 Oct 20.
Study Completion
March 2014
Actual (reported)Last Updated
July 21, 2015
Record last verified: 2015-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: