S8947-9800-9911-0016A Vitamin D Insufficiency in Determining Prognosis in Patients With Newly Diagnosed Follicular Lymphoma
Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT01131221
Collaborator
National Cancer Institute (NCI) (NIH)
196
15
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Study Type:
Observational
Actual Enrollment
:
196 participants
Time Perspective:
Retrospective
Official Title:
Vitamin D Insufficiency and Follicular Lymphoma Prognosis
Study Start Date
:
Jun 1, 2010
Actual Primary Completion Date
:
Sep 1, 2011
Actual Study Completion Date
:
Sep 1, 2011
Outcome Measures
Primary Outcome Measures
- Progression-free survival [retrospective]
Secondary Outcome Measures
- Objective response (confirmed and unconfirmed complete and partial responses) [retrospective]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
No locations specified.Sponsors and Collaborators
- Southwest Oncology Group
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Jonathan W. Friedberg, MD, James P. Wilmot Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01131221
Other Study ID Numbers:
- CDR0000671527
- SWOG-S8947-9800-9911-0016-A
First Posted:
May 26, 2010
Last Update Posted:
May 9, 2014
Last Verified:
May 1, 2014
Keywords provided by Southwest Oncology Group
Additional relevant MeSH terms: