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RecruitingObservational

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

NCT ID: NCT03617939Sponsor: University of Colorado, DenverLast updated: 2025-11-10

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.

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.

Arms & interventions

  • ProcedureBiospeciman Collection

    Collection of blood, tissue, and other biological samples.

  • OtherSurvey Assessments

    Data taken from patient surveys and assessments, including quality of life.

  • OtherMedical Chart Reviews

    Data taken directly from the patients' medical charts.

Outcome measures

Primary

  • Improve Standard of Cancer Care

    Establish a longitudinal clinical and related data and tissue repository that will contain patient demographics via surveys and questionnaires.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: Up to 20 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (6)

University of Colorado Hospital

Aurora, Colorado, 80045

Recruiting
Virgina Borges, MD · Contact
303-724-3868virginia.borges@ucdenver.edu
Virginia Borges, MD · Principal Investigator

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909

Recruiting
Sara Twombly · Contact
1.970.237.6188sara.twombly@uchealth.org

UCHealth Memorial Hospital North

Colorado Springs, Colorado, 80909

Recruiting
Alicia Deschaine · Contact
Alicia.Deschaine@uchealth.org
Robert Hoyer, MD · Principal Investigator

Cherry Creek Medical Center

Denver, Colorado, 80206

Recruiting

UCHealth Poudre Valley Health System

Fort Collins, Colorado, 80528

Recruiting
Nathan Ketelhut · Contact
Nathaniel.Ketelhut@uchealth.org
Steven Schuster, MD · Principal Investigator

Highlands Ranch Medical Center

Highlands Ranch, Colorado, 80126

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