A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Cancer Risk

Treatments: Procedure: Biospeciman Collection; Other: Medical Chart Reviews; Other: Survey Assessments

Study type: Observational

Funder types: Other

Identifiers

NCT03617939

15-1110.cc

Details and patient eligibility

About

This is not a treatment study. The overall objective is to develop an improved standard of care through studying blood, tissue, biological, etc. samples, that patients have allowed researchers to procure.

Full description

The Oncology Research Information Exchange Network (ORIEN) hopes to establish a unique collection of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) from thousands of patients with cancer or at risk of having cancer. Their hope is to, over time, facilitate new clinical trials, technology, informatics solutions, and personalized medicine to each cancer patient.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years of age and older.
2. Diagnosed with cancer, or may be at risk for cancer.
3. Able to understand and sign the TCCP Informed Consent and Research Authorization form directly or through a legally authorized representative (LAR).

Non-English speaking subjects will also be invited to participate in the TCCP study, in accordance with COMIRB's short-form consent use.

Exclusion criteria

1. Members of vulnerable populations including neonates (birth to 30 days), children (under age 18), wards of the State, prisoners or those on probation or alternate sentencing, or decisionally challenged (adults or children that are cognitively impaired, incompetent to consent, proxy consent, or consenting in life threatening situations).

Trial design

20,000 participants in 1 patient group

Biospeciman and Data Collection

Description:

Patients with cancer or who are at risk of having cancer who have given consent to have blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) collected and stored for the advancement of medicine.

Treatment:

Other: Medical Chart Reviews

Other: Survey Assessments

Procedure: Biospeciman Collection