Prospective Study of Possible Infectious Disease - Associated Antigen Drive in Previously Untreated Indolent Lymphoma

NCT00582270 | Completed

• 1 other identifier: 03-012
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.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.
2. 2.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.
3. 3.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.
4. 4.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.

Conditions

Indolent Non-Hodgkin's Lymphoma

Keywords

non-hodkin's lymphoma; follicular; non-follicular; infectious disease

Outcome Measures

Primary Outcomes (1)

• Disease status

  5 years 10 months

Study Arms (2)

1

Follicular Lymphoma

2

Non-follicular Lymphoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Follicular and non-follicular non-Hodgkin's lymphoma

You may qualify if:

• Histologically confirmed diagnosis of follicular lymphoma: grades I, II, or IIIA, or non-follicular lymphoma: lymphoplasmacytoid lymphoma, small lymphocytic lymphoma, marginal B-cell lymphoma, or MALT lymphoma (as defined in the WHO classification2) as reviewed by a hematopathologist at Memorial Hospital.
• Staging fulfills criteria for no initial treatment according to GELF criteria for advanced stage disease. None of the following should be present: 1) a nodal or extranodal mass with a diameter of \>7 cm, 2) involvement of at least three nodal sites \[each with a diameter of \>3 cm\], 3) systemic symptoms, 4) plenomegaly, or 5) ureteral compression.
• No prior treatment for lymphoma is permitted.
• Karnofsky performance status \> 70%
• The patient may not have a previous history of radiation therapy.
• Patient or guardian must be able to sign voluntary written consent.
• Male or female patients 18 years of age or greater.

You may not qualify if:

• Histologic diagnosis of intermediate grade or high grade non-Hodgkin's lymphoma.
• Histologic evidence of low grade transformation.
• Prior treatment for non-Hodgkin's lymphoma.
• Regional lymphoma (peripheral stages I and II) eligible for involved field irradiation.
• GELF criteria35 for institution of systemic chemotherapy, which includes: 1) a nodal or extranodal mass with a diameter of \>7 cm, 2) involvement of at least three nodal sites \[each with a diameter of \>3 cm\], 3) systemic symptoms, 4) splenomegaly, or 5) ureteral compression.
• Prior history of malignancy within the past five years or a concurrent malignancy, with the exceptions of cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix.
• Karnofsky Performance Status \<70%.
• Patients with a known history of HIV seropositivity.
• Patients who require therapy with systemic corticosteroids.
• Patient or responsible guardian is unable to provide written informed consent.
• Pregnant or lactating women.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carol Portlock, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: February 1, 2003
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

US (1)