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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01131221
First received: May 25, 2010
Last updated: May 8, 2014
Last verified: May 2014
  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
Study Design: Time Perspective: Retrospective
Official Title: Vitamin D Insufficiency and Follicular Lymphoma Prognosis

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: retrospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response (confirmed and unconfirmed complete and partial responses) [ Time Frame: retrospective ] [ Designated as safety issue: No ]

Enrollment: 196
Study Start Date: June 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (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
Sampling Method:   Non-Probability Sample
Study Population

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Southwest Oncology Group
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 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
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, Follicular
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014