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This study has been withdrawn prior to enrollment.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:
University of Medicine and Dentistry of New Jersey
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
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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:
Genetics Home Reference related topics:
cytogenetically normal acute myeloid leukemia
essential thrombocythemia
familial acute myeloid leukemia with mutated CEBPA
head and neck squamous cell carcinoma
mycosis fungoides
PDGFRA-associated chronic eosinophilic leukemia
Sézary syndrome
Genetic and Rare Diseases Information Center resources:
AL Amyloidosis
Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, Childhood
Acute Monoblastic Leukemia
Acute Myeloblastic Leukemia Type 5
Acute Myelocytic Leukemia
Acute Myeloid Leukemia, Adult
Acute Myeloid Leukemia, Childhood
Acute Non Lymphoblastic Leukemia
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
Squamous Cell Carcinoma of the Head and Neck
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) |
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
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 Lymphoproliferative Disorders Multiple Myeloma Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms, Plasma Cell Nervous System Neoplasms Plasmacytoma Preleukemia 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 Vascular Diseases |
ClinicalTrials.gov processed this record on February 27, 2015