Brain and Central Nervous System TumorsNCT00900120
Collecting and Storing Blood Samples From Patients With Cancer
An observational study of Brain and Central Nervous System Tumors and Chronic Myeloproliferative Disorders, run by University of Medicine and Dentistry of New Jersey.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
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
About this study
Official title: Banking DNA for Analysis of Genetic Polymorphisms in Patients With Cancer
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.
Read the 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.
- Conditions
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm
- Keywords
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorders, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA repository for long-term storage of DNA obtained from patients treated at the Cancer Institute of New Jersey
Measured: Indefinite
Investigative mechanism to allow correlations between genetic polymorphisms and clinical outcomes
Measured: Indefinite
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMar 2004
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Will be replaced by honest broker program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kim Hirshfield, MD, PhD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900120
- Sponsor's protocol ID
- 0220044856
- Other IDs
- P30CA072720, CINJ-000402, CINJ-IRB-4856
- Status last verified
- Sep 2021
- First submitted
- 9 May 2009
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Banking DNA for Analysis of Genetic Polymorphisms in Patients With Cancer
- ClinicalTrials.gov ID
- NCT00900120
- Acronym / sponsor ID
- 0220044856
- Conditions
- Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Will be replaced by honest broker program
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2004
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DNA repository for long-term storage of DNA obtained from patients treated at the Cancer Institute of New Jersey
Time frame: Indefinite
Investigative mechanism to allow correlations between genetic polymorphisms and clinical outcomes
Time frame: Indefinite
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim Hirshfield, MD, PhD principal investigator
Rutgers Cancer Institute of New Jersey
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Central Nervous System Tumors and Chronic Myeloproliferative Disorders, run by University of Medicine and Dentistry of New Jersey.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA repository for long-term storage of DNA obtained from patients treated at the Cancer Institute of New Jersey (time frame: Indefinite). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.