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Collecting and Storing Blood Samples From Patients With Cancer

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ClinicalTrials.gov Identifier: NCT00900120
Recruitment Status : Withdrawn (Will be replaced by honest broker program)
First Posted : May 12, 2009
Last Update Posted : December 12, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease
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

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.


Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Banking DNA for Analysis of Genetic Polymorphisms in Patients With Cancer
Study Start Date : March 2004
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. DNA repository for long-term storage of DNA obtained from patients treated at the Cancer Institute of New Jersey [ Time Frame: Indefinite ]
  2. Investigative mechanism to allow correlations between genetic polymorphisms and clinical outcomes [ Time Frame: Indefinite ]

Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900120


Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kim Hirshfield, MD, PhD Rutgers Cancer Institute of New Jersey
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT00900120     History of Changes
Other Study ID Numbers: CDR0000592848
P30CA072720 ( U.S. NIH Grant/Contract )
CINJ-000402
CINJ-IRB-4856
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: December 12, 2011
Last Verified: December 2011

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry 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:
Lymphoma
Disease
Syndrome
Leukemia
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Nervous System Neoplasms
Central Nervous System Neoplasms
Myeloproliferative Disorders
Plasmacytoma
Lymphoproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
 Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Neoplasms by Site