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Norris ORIEN Total Cancer Care

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ClinicalTrials.gov Identifier: NCT02970045
Recruitment Status : Recruiting
First Posted : November 21, 2016
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Study Description
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Brief Summary:
This research trial collects biological samples and clinical information to create a repository of data from patients with cancer or a predisposition for cancer. Combining genetic information from biological samples and clinical data may lead to more knowledge about why certain cancers respond to treatment and help create more personalized medicine.

Condition or disease Intervention/treatment
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

Detailed Description:

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 Design
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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
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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
Tumor tissue, bone marrow, blood, saliva, sputum, urine, feces, hair, surface skin

Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
Patients with cancer or predisposition for cancer recruited from University of Southern California/Kenneth Norris, Jr. Comprehensive Cancer Center and Hospital
Criteria

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
Contacts and Locations
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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): NCT02970045


Contacts
Contact: Melissa Woodhouse, MHA, MPH 323-865-0489 Melissa.woodhouse@med.usc.edu

Locations
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         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephen Gruber, MD University of Southern California
More Information
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02970045     History of Changes
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: February 5, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms