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

March 15, 2018 updated by: Christopher H. Lowrey, Dartmouth-Hitchcock Medical Center
The purpose of this study is to collect a blood sample from patients with Chronic Lymphocytic Leukemia (CLL) and from volunteers without CLL.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

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

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 Years

Collaborators and Investigators

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

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Christopher H Lowrey, MD, Dartmouth-Hitchcock Medical 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

May 1, 2010

Primary Completion (Anticipated)

February 1, 2011

Study Completion (Anticipated)

February 1, 2011

Study Registration Dates

First Submitted

February 15, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 15, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1019

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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