A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospeciman Collection, Survey Assessments, Medical Chart Reviews.
- Who it may be relevant to
- Registry conditions: Cancer Risk. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer (ORIEN)
Overview
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.
Interventions
- Procedure Biospeciman Collection
Collection of blood, tissue, and other biological samples. - Other Survey Assessments
Data taken from patient surveys and assessments, including quality of life. - Other Medical Chart Reviews
Data taken directly from the patients' medical charts.
Primary outcome measures
- Improve Standard of Cancer Care [Time frame: Up to 20 years]
- Improve Standard of Cancer Care [Time frame: Up to 20 years]
- Improve Standard of Cancer Care [Time frame: Up to 20 years]
- Improve Standard of Cancer Care [Time frame: Up to 20 years]
- Improve Standard of Cancer Care [Time frame: Up to 20 years]
- Improve Standard of Cancer Care [Time frame: Up to 20 years]
- Improve Standard of Cancer Care [Time frame: Up to 20 years]
Eligibility criteria
Inclusion criteria
- 18 years of age and older.
- Diagnosed with cancer, or may be at risk for cancer.
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 6 centers
- University of Colorado Hospital — Aurora
- UCHealth Memorial Hospital Central — Colorado Springs
- UCHealth Memorial Hospital North — Colorado Springs
- Cherry Creek Medical Center — Denver
- UCHealth Poudre Valley Health System — Fort Collins
- Highlands Ranch Medical Center — Highlands Ranch
Identifiers
NCT: NCT03617939 · 15-1110.cc