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

November 6, 2025 updated by: University of Colorado, Denver

Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer (ORIEN)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital
        • Contact:
        • Principal Investigator:
          • Virginia Borges, MD
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • UCHealth Memorial Hospital Central
        • Contact:
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • UCHealth Memorial Hospital North
        • Contact:
        • Principal Investigator:
          • Robert Hoyer, MD
      • Denver, Colorado, United States, 80206
        • Recruiting
        • Cherry Creek Medical Center
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • UCHealth Poudre Valley Health System
        • Contact:
        • Principal Investigator:
          • Steven Schuster, MD
      • Highlands Ranch, Colorado, United States, 80126
        • Recruiting
        • Highlands Ranch Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All persons who are diagnosed with cancer or at risk for cancer.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improve Standard of Cancer Care
Time Frame: Up to 20 years
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
Time Frame: Up to 20 years
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
Time Frame: Up to 20 years
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
Time Frame: Up to 20 years
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
Time Frame: Up to 20 years
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
Time Frame: Up to 20 years
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
Time Frame: Up to 20 years
Establish a longitudinal clinical and related data and tissue repository that will contain other biological samples from consenting patients
Up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Virginia Borges, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2015

Primary Completion (Estimated)

September 1, 2035

Study Completion (Estimated)

September 1, 2037

Study Registration Dates

First Submitted

July 3, 2018

First Submitted That Met QC Criteria

July 31, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Estimated)

November 10, 2025

Last Update Submitted That Met QC Criteria

November 6, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15-1110.cc

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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