Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2016-05-02
2037-05-02
Brief Summary
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Detailed Description
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I. To establish a longitudinal study of clinical and related data from patients with or at risk for cancer.
II. To establish a large biospecimen repository that is linked to clinical and related data.
III. To follow patients through their lifetime though passive or active follow-up.
IV. To use clinical data, tissues, other biological samples and derived molecular data in the Total Cancer Care Protocol (TCCP) repositories to match patients in this TCCP study to future studies.
OUTLINE:
Patients undergo collection of blood during a regular care visit or not up to 4 times a year. Extra tissue is collected after removal during standard of care surgery and patients may undergo additional tumor sampling (needle passes) at the time of planned diagnostic biopsies. During bone marrow biopsy, the doctor may reposition the needle up to 3 times, and bone marrow for research will not be collected more than 4 times per year. Patients may undergo additional collection of other biological samples such as saliva, sputum, urine, feces, hair, and surface skin swabs for analysis. Patients also receive surveys or questionnaires to collect demographics, medical, family, and nutritional history, cancer predisposing risk factors, quality of life data, and quality of care data.
After completion of study, patients are followed up periodically.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Ancillary-Correlative (biospecimen collection)
Patients undergo collection of blood during a regular care visit or not up to 4 times a year. Extra tissue is collected after removal during standard of care surgery and patients may undergo additional tumor sampling (needle passes) at the time of planned diagnostic biopsies. During bone marrow biopsy, the doctor may reposition the needle up to 3 times, and bone marrow for research will not be collected more than 4 times per year. Patients may undergo additional collection of other biological samples such as saliva, sputum, urine, feces, hair, and surface skin swabs for analysis. Patients also receive surveys or questionnaires to collect demographics, medical, family, and nutritional history, cancer predisposing risk factors, quality of life data, and quality of care data.
Biospecimen Collection
Undergo collection of blood, tissue, and other biological samples
Evaluation of Cancer Risk Factors
Ancillary studies
Medical Chart Review
Review of medical chart
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Biospecimen Collection
Undergo collection of blood, tissue, and other biological samples
Evaluation of Cancer Risk Factors
Ancillary studies
Medical Chart Review
Review of medical chart
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to understand and sign the TCCP informed consent, California subject's bill of rights, Health Insurance Portability and Accountability Act (HIPAA), and research authorization form directly or through an authorized representative; the informed consent, subject's bill of rights, HIPAA, and research authorization will be available in both English and Spanish languages
Exclusion Criteria
* Individuals who are unable to understand or sign the TCCP informed consent, subject's bill of rights, HIPAA, and research authorization in either English or Spanish
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Bodour Salhia, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2016-00770
Identifier Type: REGISTRY
Identifier Source: secondary_id
0S-15-12
Identifier Type: OTHER
Identifier Source: secondary_id
0S-15-12
Identifier Type: -
Identifier Source: org_study_id
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