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Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT01137643
Recruitment Status : Recruiting
First Posted : June 4, 2010
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Tracking Information
First Submitted Date June 3, 2010
First Posted Date June 4, 2010
Last Update Posted Date May 15, 2019
Study Start Date July 2009
Estimated Primary Completion Date July 2040   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 30, 2011)
  • Tissue, blood, and body fluid samples collection for ongoing diagnostic, prognostic, or immune-monitoring studies [ Time Frame: 30 years ]
  • Development of a centralized, quality-controlled, quality-assured facility for the procurement, processing, storage, and distribution of normal and malignant tissue specimens and corresponding blood specimens [ Time Frame: 30 years ]
Original Primary Outcome Measures
 (submitted: June 3, 2010)
  • Tissue, blood, and body fluid samples collection for ongoing diagnostic, prognostic, or immune-monitoring studies
  • Development of a centralized, quality-controlled, quality-assured facility for the procurement, processing, storage, and distribution of normal and malignant tissue specimens and corresponding blood specimens
Change History Complete list of historical versions of study NCT01137643 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Official Title Tissue Procurement For Hematolymphoid Conditions
Brief Summary

RATIONALE: Collecting and storing samples of tissue, blood, and body fluid from patients with cancer to study in the laboratory may help the study of cancer in the future.

PURPOSE: This research study is collecting and storing blood and tissue samples from patients being evaluated for hematologic cancer.

Detailed Description

OBJECTIVES:

  • Provide source of patient tissue, blood, and body fluid samples for ongoing diagnostic, prognostic, or immune-monitoring studies.
  • Support and enhance translational, clinical and basic research for Lineberger Comprehensive Cancer Center (LCCC) members (and non-members who have an LCCC member as sponsor and collaborator) with IRB-approved studies.
  • Maintain responsible and appropriate policies and procedures that ensure good patient care and responsible conduct of research.
  • Address medical and legal issues, and protect participant and patient privacy and confidentiality.
  • Provide a responsible and uniform mechanism for the integrated coordination of the hemato-pathologist and surgeon or hematology/oncology staff, researcher, and protocol office to obtain appropriate specimens for researchers.
  • Support young investigators to obtain pilot data for grant funding.

OUTLINE: Patients undergo tissue, blood, and body fluid collection during diagnostic or routine procedures for future correlative studies. Tissue samples may include, but are not limited to, lymph node or non-nodal biopsies, bone marrow biopsy and/or aspirate, blood and serum, and buccal swabs for germline DNA analysis.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tumor tissue, blood, bone marrow, urine, ascites
Sampling Method Non-Probability Sample
Study Population Hematologic malignancies
Condition
  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Nonmalignant Neoplasm
Intervention
  • Other: biologic sample preservation procedure
    All samples collected during routine clinical care.
  • Other: cytology specimen collection procedure
    All Samples collected during routine clinical care.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 30, 2011)
15000
Original Estimated Enrollment
 (submitted: June 3, 2010)
150
Estimated Study Completion Date July 2040
Estimated Primary Completion Date July 2040   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of abnormal hematopoietic/lymphoid cancer, including any of the following:

    • Acute myeloid leukemia
    • Acute lymphoblastic leukemia
    • Chronic myelogenous leukemia
    • Chronic lymphoid leukemia
    • Non-Hodgkin lymphoma
    • Hodgkin lymphoma
    • Myelodysplastic syndromes
    • Myeloproliferative disorders
    • Multiple myeloma
    • Waldenstrom macroglobulinemia
    • Aplastic anemia
    • Any other diseases that generate abnormalities in either number, function, or both of any cell type of hematolymphoid lineage
  • Patients who are being evaluated at the hematology/oncology clinics of the University of North Carolina Hospitals, at the stem cell transplant clinic, or in the hospital

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Paul Armistead, MD (919) 843-6847 paul_armistead@med.unc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01137643
Other Study ID Numbers LCCC 0824
P30CA016086 ( U.S. NIH Grant/Contract )
CDR0000674072 ( Other Identifier: PDQ number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party UNC Lineberger Comprehensive Cancer Center
Study Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Paul Armistead, MD UNC Lineberger Comprehensive Cancer Center
PRS Account UNC Lineberger Comprehensive Cancer Center
Verification Date May 2019