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NCT01131221 Clinical Trial

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

Lymphoma Clinical Trial

Official title:
Vitamin D Insufficiency and Follicular Lymphoma Prognosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01131221
Other study ID # CDR0000671527
Secondary ID SWOG-S8947-9800-
Status Completed
Phase N/A
First received May 25, 2010
Last updated May 8, 2014
Start date June 2010
Est. completion date September 2011

Study information
Verified date May 2014
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 196
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Southwest Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-free survival retrospective No
Secondary Objective response (confirmed and unconfirmed complete and partial responses) retrospective No
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