Partnership with patients at risk of cancer
Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer (ORIEN)
University of Colorado, Denver · NCT03617939
This study is collecting blood, tissue, and other samples from cancer patients and those at risk to see how it can help improve cancer care and support future research.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 6 sites (Aurora, Colorado and 5 other locations) |
| Trial ID | NCT03617939 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a comprehensive collection of biological samples and associated data from patients diagnosed with cancer or at risk of developing cancer. The Oncology Research Information Exchange Network (ORIEN) will gather blood, tissue, and other biological samples, along with survey data and medical records, to enhance the understanding of cancer risk and improve standard care. The ultimate goal is to facilitate future clinical trials and advancements in personalized medicine for cancer patients.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older who have been diagnosed with cancer or are at risk for cancer.
Not a fit: Patients who are part of vulnerable populations, such as children or cognitively impaired individuals, may not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could lead to improved early detection and personalized treatment options for cancer patients.
How similar studies have performed: Other studies focusing on biospecimen collection and data integration have shown promise in advancing cancer research, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Aurora, Colorado and 5 other locations
- University of Colorado Hospital — Aurora, Colorado, United States (RECRUITING)
- UCHealth Memorial Hospital Central — Colorado Springs, Colorado, United States (RECRUITING)
- UCHealth Memorial Hospital North — Colorado Springs, Colorado, United States (RECRUITING)
- Cherry Creek Medical Center — Denver, Colorado, United States (RECRUITING)
- UCHealth Poudre Valley Health System — Fort Collins, Colorado, United States (RECRUITING)
- Highlands Ranch Medical Center — Highlands Ranch, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Virginia Borges, MD — University of Colorado, Denver
- Study coordinator: Kyra Anderson
- Email: kyra.anderson@cuanschutz.edu
- Phone: 303-724-3868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer Risk, Tissue Repository, Blood Samples, Biological Samples, Surveys, Early Detection, Risk Assessment