A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer
Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer (ORIEN)
1 other identifier
observational
20,000
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 16, 2015
CompletedFirst Submitted
Initial submission to the registry
July 3, 2018
CompletedFirst Posted
Study publicly available on registry
August 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2037
November 10, 2025
November 1, 2025
20 years
July 3, 2018
November 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Improve Standard of Cancer Care
Establish a longitudinal clinical and related data and tissue repository that will contain patient demographics via surveys and questionnaires.
Up to 20 years
Improve Standard of Cancer Care
Establish a longitudinal clinical and related data and tissue repository that will contain medical histories via surveys and questionnaires.
Up to 20 years
Improve Standard of Cancer Care
Establish a longitudinal clinical and related data and tissue repository that will contain cancer predisposing risk factors via surveys and questionnaires.
Up to 20 years
Improve Standard of Cancer Care
Establish a longitudinal clinical and related data and tissue repository that will contain quality of life care via surveys and questionnaires
Up to 20 years
Improve Standard of Cancer Care
Establish a longitudinal clinical and related data and tissue repository that will contain blood samples from consenting patients.
Up to 20 years
Improve Standard of Cancer Care
Establish a longitudinal clinical and related data and tissue repository that will contain tissue samples from consenting patients
Up to 20 years
Improve Standard of Cancer Care
Establish a longitudinal clinical and related data and tissue repository that will contain other biological samples from consenting patients
Up to 20 years
Study Arms (1)
Biospeciman and Data Collection
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.
Interventions
Collection of blood, tissue, and other biological samples.
Data taken from patient surveys and assessments, including quality of life.
Data taken directly from the patients' medical charts.
Eligibility Criteria
All persons who are diagnosed with cancer or at risk for cancer.
You may qualify if:
- 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.
You may not qualify if:
- \. 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Colorado Hospital
Aurora, Colorado, 80045, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
UCHealth Memorial Hospital North
Colorado Springs, Colorado, 80909, United States
Cherry Creek Medical Center
Denver, Colorado, 80206, United States
UCHealth Poudre Valley Health System
Fort Collins, Colorado, 80528, United States
Highlands Ranch Medical Center
Highlands Ranch, Colorado, 80126, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Virginia Borges, MD
University of Colorado, Denver
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2018
First Posted
August 7, 2018
Study Start
September 16, 2015
Primary Completion (Estimated)
September 1, 2035
Study Completion (Estimated)
September 1, 2037
Last Updated
November 10, 2025
Record last verified: 2025-11