An Observational Study of Treatment, Outcomes, and Prognosis in Patients With Follicular Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.

First Received on November 24, 2004. Last Updated on August 9, 2011 History of Changes

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00097565

Purpose

This is a prospective, observational, longitudinal, multicenter study of patients with newly diagnosed follicular Non Hodgkin's Lymphoma (NHL) designed to delineate differences in clinical outcome by comparing the effectiveness and safety of common treatment regimens.

Condition	Phase
Lymphoma, Non Hodgkin	Phase IV

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	The National Lymphocare Study: An Observational Study of Treatment, Outcomes, and Prognosis in Patients With Follicular Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

U.S. FDA Resources

Further study details as provided by Genentech:

Enrollment:	2743
Study Start Date:	September 2004
Estimated Study Completion Date:	March 2017

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with follicular NHL will be recruited from participating managed care organizations, community physicians or practices, and academic centers throughout the United States.

Criteria

Inclusion Criteria:

Signed Informed Consent Form (unless the Institutional Review Board [IRB] has granted a waiver of consent)
Signed Authorization for the Use and Disclosure of Health Information document
Age ≥18 years
Histologic documentation of follicular NHL, according to Revised European-American Lymphoma (REAL) classification system, as assessed by the local pathologist and treating physician
Initial diagnosis of follicular B-cell NHL within 6 months prior to enrollment
Availability of cancer-specific historical data points in the patient's medical records

Exclusion Criteria:

Other indolent or histologic NHL subtypes
Diagnosis of lymphoma > 6 months prior to enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097565

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Berthold Greifenberg, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00097565 History of Changes
Other Study ID Numbers:	U2963n
Study First Received:	November 24, 2004
Last Updated:	August 9, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Genentech:

Follicular Non-Hodgkin's Lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012