Cancer RiskNCT03617939
A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer
An observational study of Cancer Risk, run by University of Colorado, Denver at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Risk
- What is being tested?
- Biospeciman Collection, Survey Assessments and Medical Chart Reviews
- Type of treatment
- Surgery or procedure
- How many people
- 20,000 participants
- Where
- 6 sitesUnited States
- Study dates
- 16 Sep 2015to Sep 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All persons who are diagnosed with cancer or at risk for cancer.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Virgina Borges, MD, 303-724-3868, virginia.borges@ucdenver.edu
Virginia Borges, MD
- Recruiting
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Sara Twombly, 1.970.237.6188, sara.twombly@uchealth.org
- Recruiting
UCHealth Memorial Hospital North
Colorado Springs, Colorado, 80909
Alicia Deschaine, Alicia.Deschaine@uchealth.org
Robert Hoyer, MD
- Recruiting
Cherry Creek Medical Center
Denver, Colorado, 80206
- Recruiting
UCHealth Poudre Valley Health System
Fort Collins, Colorado, 80528
Nathan Ketelhut, Nathaniel.Ketelhut@uchealth.org
Steven Schuster, MD
- Recruiting
Highlands Ranch Medical Center
Highlands Ranch, Colorado, 80126
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer Risk
- Being tested
- Biospeciman Collection, Survey Assessments, Medical Chart Reviews
- Keywords
- Tissue Repository, Blood Samples, Biological Samples, Surveys, Early Detection, Risk Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospeciman CollectionProcedure or surgery
Collection of blood, tissue, and other biological samples.
Survey AssessmentsOther
Data taken from patient surveys and assessments, including quality of life.
Medical Chart ReviewsOther
Data taken directly from the patients' medical charts.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospeciman Collection; Other: Survey Assessments; Other: Medical Chart Reviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve Standard of Cancer Care
Establish a longitudinal clinical and related data and tissue repository that will contain patient demographics via surveys and questionnaires.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start16 Sep 2015
- Primary completionSep 2035 (estimated)
- Study completionSep 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer RiskStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginia Borges, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617939
- Sponsor's protocol ID
- 15-1110.cc
- Status last verified
- Nov 2025
- First submitted
- 3 Jul 2018
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer (ORIEN)
- ClinicalTrials.gov ID
- NCT03617939
- Acronym / sponsor ID
- 15-1110.cc
- Conditions
- Cancer Risk
- Keywords
- Tissue Repository, Blood Samples, Biological Samples, Surveys, Early Detection, Risk Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 16 Sep 2015 (actual)
- Primary completion
- Sep 2035 (estimated)
- Study completion
- Sep 2037 (estimated)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biospeciman and Data Collection | – | Procedure: Biospeciman Collection, Other: Survey Assessments, Other: Medical Chart ReviewsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All persons who are diagnosed with cancer or at risk for cancer.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospeciman CollectionCollection of blood, tissue, and other biological samples. | Procedure or surgery | Biospeciman and Data Collection |
| Survey AssessmentsData taken from patient surveys and assessments, including quality of life. | Other | Biospeciman and Data Collection |
| Medical Chart ReviewsData taken directly from the patients' medical charts. | Other | Biospeciman and Data Collection |
Primary outcome
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.
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.
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.
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
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.
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Virginia Borges, MD principal investigator
University of Colorado, Denver
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Risk, run by University of Colorado, Denver at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyra Anderson (303-724-3868, kyra.anderson@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve Standard of Cancer Care (time frame: Up to 20 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.