Protocol to Obtain Blood for Discovery of Novel Biomarkers and Potential Therapeutic Targets in Chronic Lymphocytic Leukemia

This study has been withdrawn prior to enrollment.
(IRB delayed their review for an extensive period of time. Funding for this protocol is no longer available.)
Sponsor:
Information provided by:
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01069432
First received: February 15, 2010
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to collect a blood sample from patients with Chronic Lymphocytic Leukemia (CLL) and from volunteers without CLL.


Condition Intervention
Chronic Lymphocytic Leukemia
Other: No Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protocol to Obtain Blood for Discovery of Novel Biomarkers and Potential Therapeutic Targets in Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • To identify the genes that are differentially expressed at the polysomal RNA and protein levels in human patient CLL cells (compared to normal donor lymphocytes) using high-throughput microarray approaches. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether the novel candidate genes from Specific Aim 1 have potential roles in CLL. (Note: Specific Aim 2 does not involve human subjects research). [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

10cc of peripheral blood.


Enrollment: 0
Study Start Date: May 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with CLL
Patients undergoing routine blood draws as part of their ongoing follow-up care for CLL at the Norris Cotton Cancer Center of DHMC.
Other: No Intervention
No Intervention
Normal Volunteers
Normal volunteers who have no history of active or prior hematologic malignancy.
Other: No Intervention
No Intervention

Detailed Description:

The blood sample will be used in the laboratory to perform focused studies on Chronic Lymphocytic Leukemia (CLL).

  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 at Dartmouth-Hitchcock Medical Center's Norris Cotton Cancer Center

Criteria

Inclusion Criteria:

  • Patients undergoing routine blood draws as part of their ongoing follow-up care for CLL at the Norris Cotton Cancer Center of DHMC.
  • Normal donors who have no history of active or prior hematologic malignancy.

Exclusion Criteria:

  • Patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for their CLL, other hematologic malignancy or other disease process within the past 2 months are excluded. Use of intravenous immunoglobulin (IVIg) is not a reason for exclusion.
  • Normal donors who have a history of steroid use, immunosuppression therapy or autoimmune disease are excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069432

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Christopher H Lowrey, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Christopher Lowrey, MD, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01069432     History of Changes
Other Study ID Numbers: D1019
Study First Received: February 15, 2010
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Chronic Lymphocytic Leukemia
CLL
Normal Volunteers

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014