Prospective Study of Frontline H Pylori Eradication in the Treatment of Early-stage Extragastric MALT Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02987127|
Recruitment Status : Unknown
Verified December 2016 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : December 8, 2016
Last Update Posted : December 8, 2016
|Condition or disease|
|Mucosa-Associated Lymphoid Tissue Lymphoma|
Through a prospective trial of frontline HPE in the treatment of early-stage extragastric MALToma, investigators will evaluate and investigate the following issues:
- The CR and partial remission (PR) rate for antibiotics as 1st-line therapy for stage IE and stage IIE extragastric MALToma
- The durability of CR and PR (relapse-free survival) after antibiotics treatment (HPE) in early-stage extragastric MALToma
- The assessment of the evidence of bacterial infection, such as HP, in extragastric MALToma.
- The identification of potential biomarkers that help us predict whether extragastric MALToma can respond to frontline HPE.
|Study Type :||Observational|
|Estimated Enrollment :||21 participants|
|Official Title:||Prospective Study of Frontline Helicobacter Pylori Eradication Therapy in the Treatment of Early-stage Extragastric Mucosa-associated Lymphoid Tissue Lymphoma|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
- The complete and partial remission rate for antibiotics as 1st-line therapy for stage IE-IIE1 extragastric MALT lymphoma. [ Time Frame: 5 years ]The complete remission rate and partial remission rate for antibiotics (HP eradicaiton) as 1st-line therapy for early-stage extragastric MALT lymphoma
- The overall survival of early-stage extragastric MALT lymphoma patients who received frontline HP eradication therapy [ Time Frame: 5 years ]
- The assessment of the evidence of bacterial infection in all extragstric MALT lymphoma [ Time Frame: 5 years ]
- The usefulness of pattern of NF-κB, BCL10, BAFF, API2-MALT1, and IgH-MALT1 by IHC staining or FISH in prospectively predicting the antibiotics responsiveness of extragastric MALT lymphoma [ Time Frame: 5 years ]
- The relapse-free survival of early-stage extragastric MALT lymphoma patients who received antibiotics as 1st-line therapy [ Time Frame: 5 years ]
- The complete remission rate and durability of second-line chemotherapy with chlorambucil plus prednisolone for progressive disease after frontline HP eradication therapy [ Time Frame: 5 years ]
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): NCT02987127
|Contact: Sung-Hsin Kuo, M.D.,Ph.D||+886-2-23123456 ext email@example.com|
|Contact: Shu-Ling Wu, MS||+886-2-23123456 ext firstname.lastname@example.org|
|Principal Investigator:||Sung-Hsin Kuo, M.D.,Ph.D||National Taiwan University Hospital|