Norris ORIEN Total Cancer Care
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ClinicalTrials.gov Identifier: NCT02970045 |
Recruitment Status :
Recruiting
First Posted : November 21, 2016
Last Update Posted : May 20, 2019
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Condition or disease | Intervention/treatment |
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Cancer Risk Malignant Neoplasm | Procedure: Biospecimen Collection Procedure: Evaluation of Cancer Risk Factors Other: Medical Chart Review Other: Quality-of-Life Assessment Other: Questionnaire Administration |
PRIMARY OBJECTIVES:
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.
Study Type : | Observational |
Estimated Enrollment : | 10000 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Norris ORIEN Total Cancer Care Protocol: A Lifetime Partnership With Patients |
Actual Study Start Date : | May 2, 2016 |
Estimated Primary Completion Date : | May 2, 2036 |
Estimated Study Completion Date : | May 2, 2037 |
Group/Cohort | Intervention/treatment |
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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.
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Procedure: Biospecimen Collection
Undergo collection of blood, tissue, and other biological samples Procedure: Evaluation of Cancer Risk Factors Ancillary studies
Other Name: cancer risk factors evaluation Other: Medical Chart Review Review of medical chart
Other Name: Chart Review Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies |
- Number of biospecimen collected for a centralized repository that is linked to clinical data [ Time Frame: Up to 21 years ]Establish and maintain a unique repository of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) collected from thousands of patients 18 years of age or older who have cancer or are at risk of developing cancer.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Limited to those patients who are registered for outpatient or inpatient care at University of Southern California (USC) Norris
- 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 not registered as patients for outpatient or inpatient care at USC Norris
- 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

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): NCT02970045
Contact: Melissa Woodhouse, MHA, MPH | 323-865-0489 | Melissa.woodhouse@med.usc.edu |
United States, California | |
USC / Norris Comprehensive Cancer Center | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Melissa Woodhouse, MHA, MPH 323-865-0489 Melissa.woodhouse@med.usc.edu | |
Principal Investigator: Stephen B. Gruber, MD |
Principal Investigator: | Stephen Gruber, MD | University of Southern California |
Responsible Party: | University of Southern California |
ClinicalTrials.gov Identifier: | NCT02970045 |
Other Study ID Numbers: |
0S-15-12 NCI-2016-00770 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 0S-15-12 ( Other Identifier: USC / Norris Comprehensive Cancer Center ) P30CA014089 ( U.S. NIH Grant/Contract ) |
First Posted: | November 21, 2016 Key Record Dates |
Last Update Posted: | May 20, 2019 |
Last Verified: | May 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasms |