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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00097565
First received: November 24, 2004
Last updated: March 21, 2017
Last verified: March 2017
  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
Lymphoma, Non Hodgkin

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:


Further study details as provided by Genentech, Inc.:

Enrollment: 2740
Actual Study Start Date: March 2004
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  Eligibility

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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Genentech, Inc.
Investigators
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
Study First Received: November 24, 2004
Last Updated: March 21, 2017

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

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

ClinicalTrials.gov processed this record on September 21, 2017