S8947-9800-9911-0016A Vitamin D Insufficiency in Determining Prognosis in Patients With Newly Diagnosed Follicular Lymphoma

Completed

• Conditions: Lymphoma

• Registration Number: NCT01131221
• Lead Sponsor: SWOG Cancer Research Network

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.

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 Timeline

• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-26
• Study Start: 2010-06
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival	retrospective

Secondary Outcome Measures

Name	Time	Method
Objective response (confirmed and unconfirmed complete and partial responses)	retrospective