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

Withdrawn

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Other: No Intervention

• Registration Number: NCT01069432
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2010-02-15
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Study Start: 2010-05
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-15
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with CLL	No Intervention	Patients undergoing routine blood draws as part of their ongoing follow-up care for CLL at the Norris Cotton Cancer Center of DHMC.
Normal Volunteers	No Intervention	Normal volunteers who have no history of active or prior hematologic malignancy.

Primary Outcome Measures

Name	Time	Method
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.	2 Years

Secondary Outcome Measures

Name	Time	Method
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).	2 Years

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States