Norris ORIEN Total Cancer Care

NCT ID: NCT02970045

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-02

Study Completion Date

2037-05-02

Brief Summary

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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

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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.

Conditions

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Cancer Risk Malignant Neoplasm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood, tissue, and other biological samples

Evaluation of Cancer Risk Factors

Intervention Type PROCEDURE

Ancillary studies

Medical Chart Review

Intervention Type OTHER

Review of medical chart

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Biospecimen Collection

Undergo collection of blood, tissue, and other biological samples

Intervention Type PROCEDURE

Evaluation of Cancer Risk Factors

Ancillary studies

Intervention Type PROCEDURE

Medical Chart Review

Review of medical chart

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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cancer risk factors evaluation Chart Review Quality of Life Assessment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bodour Salhia, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Melissa Woodhouse, MHA, MPH

Role: CONTACT

323-865-0489

Facility Contacts

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Melissa Woodhouse, MHA, MPH

Role: primary

323-865-0489

Other Identifiers

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NCI-2016-00770

Identifier Type: REGISTRY

Identifier Source: secondary_id

0S-15-12

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0S-15-12

Identifier Type: -

Identifier Source: org_study_id

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