Norris ORIEN Total Cancer Care

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

• Number of biospecimen collected for a centralized repository that is linked to clinical data [Time frame: Up to 21 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

United States · 1 center

• USC / Norris Comprehensive Cancer Center — Los Angeles

Identifiers

NCT: NCT02970045 · 0S-15-12 · NCI-2016-00770 · 0S-15-12 · P30CA014089

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗