Collecting and Storing Blood Samples From Patients With Cancer

This study has been withdrawn prior to enrollment.
(Will be replaced by honest broker program)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00900120
First received: May 9, 2009
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

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

PURPOSE: This research study is collecting and storing blood samples from patients with cancer.


Condition
Brain and Central Nervous System Tumors
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Nonmalignant Neoplasm
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Banking DNA for Analysis of Genetic Polymorphisms in Patients With Cancer

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia, Childhood Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Acute Myeloid Leukemia, Childhood Acute Non Lymphoblastic Leukemia AL Amyloidosis Anaplastic Large Cell Lymphoma Anaplastic Plasmacytoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Angioimmunoblastic T-cell Lymphoma Aplastic Anemia B-cell Lymphomas Burkitt Lymphoma Central Nervous System Lymphoma, Primary Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Chronic Myeloproliferative Disorders Chronic Neutrophilic Leukemia Cutaneous T-cell Lymphoma Essential Thrombocythemia Follicular Lymphoma Hairy Cell Leukemia Hodgkin Lymphoma Hodgkin Lymphoma, Childhood Hypereosinophilic Syndrome Juvenile Myelomonocytic Leukemia Large Granular Lymphocyte Leukemia Leukemia, B-cell, Chronic Leukemia, Myeloid Leukemia, T-cell, Chronic Lymphoblastic Lymphoma Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphomatoid Granulomatosis Lymphosarcoma Mantle Cell Lymphoma Multiple Myeloma Mycosis Fungoides Myelodysplastic Syndromes Myelodysplastic/myeloproliferative Disease Myelofibrosis Plasmablastic Lymphoma Polycythemia Vera Sezary Syndrome Small Non-cleaved Cell Lymphoma Systemic Mastocytosis Waldenstrom Macroglobulinemia
U.S. FDA Resources

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • DNA repository for long-term storage of DNA obtained from patients treated at the Cancer Institute of New Jersey [ Time Frame: Indefinite ] [ Designated as safety issue: No ]
  • Investigative mechanism to allow correlations between genetic polymorphisms and clinical outcomes [ Time Frame: Indefinite ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Enrollment: 0
Study Start Date: March 2004
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To establish a repository for long-term storage of DNA obtained from patients treated at the Cancer Institute of New Jersey.
  • To establish a mechanism whereby investigators can analyze correlations between genetic polymorphisms and clinical outcomes (e.g., response to treatment).

OUTLINE: Additional blood samples are collected for banking from patients while they are scheduled for routine blood draw as a part of their normal care. Samples are stored in a secure place under the control of the Cancer Institute of New Jersey Tissue Retrieval service. The samples may be used for DNA, RNA, or protein extraction and analyses, as well as generation of cell lines.

Demographic data (ethnicity, race, age, and sex), diagnosis, family history, and previous treatments (chemotherapy, radiation, and surgery) are recorded on the case report form and kept in a secure location in the Office of Human Research Services (OHRS).

Patients may have their samples removed and destroyed at any time.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients seen at CINJ who have a diagnosis of cancer and plan to be treated at CINJ will be asked to participate in this DNA banking resource

Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed malignancy or bone marrow disorder (i.e., myelodysplasia, myeloproliferative syndrome, or aplastic anemia)
  • Must be undergoing treatment or planning to undergo treatment at the Cancer Institute of New Jersey

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: NCT00900120

Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Kim Hirshfield, MD, PhD Rutgers Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00900120     History of Changes
Other Study ID Numbers: CDR0000592848, P30CA072720, CINJ-000402, CINJ-IRB-4856
Study First Received: May 9, 2009
Last Updated: December 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
aplastic anemia
myelodysplastic/myeloproliferative neoplasm, unclassifiable
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific
secondary myelodysplastic syndromes
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
atypical chronic myeloid leukemia, BCR-ABL negative
blastic phase chronic myelogenous leukemia
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
juvenile myelomonocytic leukemia
mast cell leukemia
meningeal chronic myelogenous leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult T-cell leukemia/lymphoma
recurrent childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Disease
Leukemia
Lymphoma
Lymphoproliferative Disorders
Multiple Myeloma
Myelodysplastic Syndromes
Myelodysplastic-Myeloproliferative Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms, Plasma Cell
Nervous System Neoplasms
Plasmacytoma
Preleukemia
Syndrome
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases
Paraproteinemias
Pathologic Processes
Precancerous Conditions

ClinicalTrials.gov processed this record on October 23, 2014