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:
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
  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)
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.

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131221

Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: Jonathan W. Friedberg, MD James P. Wilmot Cancer Center
  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 April 16, 2014