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

May 8, 2014 updated by: Southwest Oncology Group

Vitamin D Insufficiency and Follicular Lymphoma Prognosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

196

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients enrolled in S8947-9800-9911-0016 consenting to banking

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: retrospective
retrospective

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response (confirmed and unconfirmed complete and partial responses)
Time Frame: retrospective
retrospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jonathan W. Friedberg, MD, James P. Wilmot Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 25, 2010

First Submitted That Met QC Criteria

May 25, 2010

First Posted (Estimate)

May 26, 2010

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000671527
  • SWOG-S8947-9800-9911-0016-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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