Clinical trial NCT03617939: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer
Official title: Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer (ORIEN)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer Risk
Keywords: Tissue Repository
Blood Samples
Biological Samples
Surveys
Early Detection
Risk Assessment
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All persons who are diagnosed with cancer or at risk for cancer.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Improve Standard of Cancer Care
timeFrame: Up to 20 years
measure: Improve Standard of Cancer Care
timeFrame: Up to 20 years
measure: Improve Standard of Cancer Care
timeFrame: Up to 20 years
measure: Improve Standard of Cancer Care
timeFrame: Up to 20 years
measure: Improve Standard of Cancer Care
timeFrame: Up to 20 years
measure: Improve Standard of Cancer Care
timeFrame: Up to 20 years
measure: Improve Standard of Cancer Care
timeFrame: Up to 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Memorial Hospital Central
state: Colorado
city: Colorado Springs
country: United States
facility: UCHealth Memorial Hospital North
state: Colorado
city: Denver
country: United States
facility: Cherry Creek Medical Center
state: Colorado
city: Fort Collins
country: United States
facility: UCHealth Poudre Valley Health System
state: Colorado
city: Highlands Ranch
country: United States
facility: Highlands Ranch Medical Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Virginia Borges, MD
role: PRINCIPAL_INVESTIGATOR
References: