NCT01583699

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

1.9 years

First QC Date

January 8, 2012

Last Update Submit

July 19, 2015

Conditions

MALT-lymphoma

Keywords

MALT-lymphomaConfocal laser endomicroscopyGastrointestinal endoscopy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Sensitivity and Specificity of Endomicroscopy to diagnose GI-MALT-Lymphoma

    2 years

Study Arms (1)

Endomicroscopy

EXPERIMENTAL

All patients included into the study will undergo endomicroscopy of the upper GI-tract.

Procedure: Confocal laser endomicroscopyDevice: Confocal Laser Endomicroscope

Interventions

Confocal laser endomicroscopyPROCEDURE

Endomicroscopy of the upper gastrointestinal tract to capture endomicroscopic pictures from the small bowel, stomach and esophagus.

Endomicroscopy
Confocal Laser EndomicroscopeDEVICE

Pentax EC-3870 CIFK with the ISC-1000 confocal endomicroscopy processor - Pentax, Tokyo, Japan and Optiscan Pty Ltd, Notting Hill, Victoria, Australia

Endomicroscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred to our department for upper endoscopy in the context of staging or follow-up of gastric MALT-lymphoma.

You may not qualify if:

  • patients allergic to one of the drug components (including drugs used for conscious sedation like propofol or midazolam as well as fluorescein, the fluorescent dye used for CLE )
  • refusal to participate in the study
  • patient's age below 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology

Vienna, Austria

Location

Related Publications (19)

  • 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.

    PMID: 19669189BACKGROUND

  • 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.

    PMID: 17583528BACKGROUND

  • 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.

    PMID: 17659705BACKGROUND

  • 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.

    PMID: 19532131BACKGROUND

  • 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.

    PMID: 18212490BACKGROUND

  • 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.

    PMID: 12113133BACKGROUND

  • 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.

    PMID: 15867234BACKGROUND

  • Isaacson PG. Gastric MALT lymphoma: from concept to cure. Ann Oncol. 1999 Jun;10(6):637-45. doi: 10.1023/a:1008396618983.

    PMID: 10442184BACKGROUND

  • 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.

    PMID: 21656457BACKGROUND

  • Hyatt BJ, Paull PE, Wassef W. Gastric oncology: an update. Curr Opin Gastroenterol. 2009 Nov;25(6):570-8. doi: 10.1097/MOG.0b013e328331b5c9.

    PMID: 19816172BACKGROUND

  • 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.

    PMID: 12377808BACKGROUND

  • 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.

    PMID: 18537089BACKGROUND

  • Kiesslich R, Galle P, Neurath M. Atlas of endomicroscopy. Springer Medical Publishing. 2008

    BACKGROUND

  • 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.

    PMID: 15940642BACKGROUND

  • 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.

    PMID: 21113886BACKGROUND

  • 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.

    PMID: 16843068BACKGROUND

  • 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.

    PMID: 19559419BACKGROUND

  • 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.

    PMID: 17383417BACKGROUND

  • 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.

    PMID: 26487230DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Werner Dolak, MD

    Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterologie and Hepatologie

    PRINCIPAL INVESTIGATOR

  • Andreas Puespoek, m

    Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology

    STUDY DIRECTOR

  • Markus Raderer, MD

    Medical University of Vienna, Department of Internal Medicine I, Division of Oncology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2012

First Posted

April 24, 2012

Study Start

April 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

AU(1)