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)

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: Cancer Risk
• Intervention / Treatment: Procedure: Biospeciman Collection; Other: Survey Assessments; Other: Medical Chart Reviews

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 (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Virginia Borges, MD; Phone Number: 303-724-3868; Email: virginia.borges@ucdenver.edu
• Study Contact Backup: Name: Kyra Anderson; Phone Number: 303-724-9527; Email: kyra.anderson@ucdenver.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital
      • Contact: Virgina Borges, MD; Phone Number: 303-724-3868; Email: virginia.borges@ucdenver.edu
      • Principal Investigator: Virginia Borges, MD
    • Colorado Springs, Colorado, United States, 80909
      • Recruiting
      • UCHealth Memorial Hospital
      • Contact: Alicia Deschaine; Email: Alicia.Deschaine@uchealth.org
      • Principal Investigator: Robert Hoyer, MD
    • Fort Collins, Colorado, United States, 80528
      • Recruiting
      • UCHealth Poudre Valley Health System
      • Contact: Nathan Ketelhut; Email: Nathaniel.Ketelhut@uchealth.org

Participation Criteria

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

How is the study designed?

Design Details

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

Number of groups / cohorts

1

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	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2015
• Primary Completion (Anticipated): September 1, 2035
• Study Completion (Anticipated): 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 (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Risk Assessment; Surveys; Tissue Repository; Blood Samples; Biological Samples; Early Detection
• 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