Vitamin D Insufficiency in Determining Prognosis in Patients With Newly Diagnosed Follicular Lymphoma
This study is not yet open for participant recruitment.
Verified April 2010 by National Cancer Institute (NCI)
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01131221
First received: May 25, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
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Purpose
RATIONALE: Studying samples of serum from patients with cancer in the laboratory may help doctors identify and learn more biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.
PURPOSE: This research study is studying vitamin D insufficiency in determining prognosis in patients with newly diagnosed follicular lymphoma.
| Condition | Intervention |
|---|---|
|
Lymphoma |
Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Vitamin D Insufficiency and Follicular Lymphoma Prognosis |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Progression-free survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective response (confirmed and unconfirmed complete and partial responses) [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2010 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To evaluate the role of pre-treatment serum 25(OH)D with regard to progression-free survival and objective response among patients with newly diagnosed follicular lymphoma, within the context of a uniformly treated and evaluated Phase III clinical trial in the modern therapeutic era.
OUTLINE: This is a multicenter study.
Pre-treatment serum samples are analyzed for 25(OH)D levels to determine vitamin D sufficiency or insufficiency.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed CD20+ follicular lymphoma
- Enrolled on clinical trial SWOG-S0016, SWOG-9800, or SWOG-9911
- Pre-treatment serum available through SWOG-8947
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Jonathan W. Friedberg, James P. Wilmot Cancer Center at University of Rochester Medical Center |
| ClinicalTrials.gov Identifier: | NCT01131221 History of Changes |
| Other Study ID Numbers: | CDR0000671527, SWOG-S8947-9800-9911-0016-A |
| Study First Received: | May 25, 2010 |
| Last Updated: | May 25, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma contiguous stage II grade 3 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma |
stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Vitamin D Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013