Prospective Study of Possible Infectious Disease - Associated Antigen Drive in Previously Untreated Indolent Lymphoma
The purpose of this study is to determine if an infectious disease may be associated with the new lymphoma diagnosis.
Infections to be tested include:
- Helicobacter pylori (H. pylori): This is a bacteria sometimes found in the stomach that has been associated with a particular kind of lymphoma, gastric MALT. We are interested to learn if the H. pylori infection may be associated with other indolent lymphomas.
- Hepatitis C: This virus infection of the liver has been found in association with non-follicular lymphomas in Italy. We want to determine if the infection is associated with lymphomas in the United States.
- Bacterial overgrowth of the small bowel: Since indolent lymphomas often affect the lymph nodes surrounding the small bowel, it may be possible that an infection within the bowel is stimulating lymphoma growth. This has never been demonstrated to date, and will be studied in this clinical study.
- Epstein-Barr virus: This is the virus that causes infectious mononucleosis or "mono." It has been associated with other rapidly growing lymphomas, but not indolent lymphoma.
Indolent Non-Hodgkin's Lymphoma
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective Study of Possible Infectious Disease - Associated Antigen Drive in Previously Untreated Indolent Lymphoma|
- Disease status [ Time Frame: 5 years 10 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2003|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
This is a prospective observational clinical study of possible infectious disease-associated antigen drive in previously untreated patients with indolent lymphoma (follicular and nonfollicular cohorts).
Eligible patients with a new diagnosis of indolent lymphoma will be enrolled after informed consent. All patients will be tested for possible known infectious diseases that may contribute to antigen drive (H. Pylori; Hepatitis C), as well as for other infectious diseases not yet established as contributing to antigen drive (Borrelia; Chlamydia; and small bowel overgrowth). All patients will have a complete history recorded regarding other possible chronic infections, and an infectious disease consultation, as indicated.
Patients with positive antigen-drive infectious disease studies will be treated as indicated with standard antibiotic regimens and response (both infectious disease as well as lymphoma status)will be documented and recorded.
The primary objective of this study is (1) to evaluate the possible association of infectious diseases in previously untreated patients with indolent lymphoma. The secondary objective of this study is to evaluate possible lymphoma response the in patients treated for positive infectious disease studies; and to evaluate EBV immune responses in these previously untreated patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582270
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Carol Portlock, MD||Memorial Sloan-Kettering Cancer Center|