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An Observational Study of Treatment, Outcomes, and Prognosis in Patients With Follicular Non-Hodgkin's 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: NCT00097565
Recruitment Status : Completed
First Posted : November 25, 2004
Last Update Posted : March 23, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Lymphoma, Non Hodgkin

Study Design

Study Type : Observational
Actual Enrollment : 2740 participants
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
Actual Study Start Date : March 2004
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

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): NCT00097565

Sponsors and Collaborators
Genentech, Inc.
Study Director: Cinical Trials Genentech, Inc.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00097565     History of Changes
Other Study ID Numbers: U2963n
First Posted: November 25, 2004    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

Keywords provided by Genentech, Inc.:
Follicular Non-Hodgkin's Lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases