An Observational Study of Treatment, Outcomes, and Prognosis in Patients With Follicular Non-Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT00097565 |
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Recruitment Status :
Completed
First Posted : November 25, 2004
Last Update Posted : March 23, 2017
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Sponsor:
Genentech, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
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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 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 |
| Actual Primary Completion Date : | March 2014 |
| Actual Study Completion Date : | March 2014 |
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
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.
Investigators
| Study Director: | Cinical Trials | Genentech, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT00097565 |
| 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.:
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Follicular Non-Hodgkin's Lymphoma |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |