Norris ORIEN Total Cancer Care

February 14, 2024 updated by: University of Southern California

Norris ORIEN Total Cancer Care Protocol: A Lifetime Partnership With Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC / Norris Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Bodour Salhia, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Medical Chart Review
Review of medical chart
Other Names:
  • Chart Review
Procedure: Evaluation of Cancer Risk Factors
Ancillary studies
Other Names:
  • cancer risk factors evaluation
Procedure: Biospecimen Collection
Undergo collection of blood, tissue, and other biological samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 21 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Bodour Salhia, PhD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2016

Primary Completion (Estimated)

May 2, 2036

Study Completion (Estimated)

May 2, 2037

Study Registration Dates

First Submitted

July 29, 2016

First Submitted That Met QC Criteria

November 17, 2016

First Posted (Estimated)

November 21, 2016

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0S-15-12 (Other Identifier: USC / Norris Comprehensive Cancer Center)
  • P30CA014089 (U.S. NIH Grant/Contract)
  • NCI-2016-00770 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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