Norris ORIEN Total Cancer Care

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02970045
• Other study ID #: 0S-15-12
• Secondary ID: NCI-2016-007700S
• Status: Recruiting
• Start date: May 2, 2016
• Est. completion date: May 2, 2037

Study information

• Verified date: February 2024
• Source: University of Southern California
• Contact: Melissa Woodhouse, MHA, MPH
• Phone: 323-865-0489
• Email: Melissa.woodhouse[@]med.usc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: May 2, 2037
• Est. primary completion date: May 2, 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Risk
• Malignant Neoplasm
• Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood, tissue, and other biological samples
• Evaluation of Cancer Risk Factors
Ancillary studies

Other:
• Medical Chart Review
Review of medical chart
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of biospecimen collected for a centralized repository that is linked to clinical data	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