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Clinical Trials/NCT03617939
NCT03617939
Recruiting
Not Applicable

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

University of Colorado, Denver6 sites in 1 country20,000 target enrollmentSeptember 16, 2015
ConditionsCancer Risk

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer Risk
Sponsor
University of Colorado, Denver
Enrollment
20000
Locations
6
Primary Endpoint
Improve Standard of Cancer Care
Status
Recruiting
Last Updated
5 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 16, 2015
End Date
September 1, 2037
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

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).

Outcomes

Primary Outcomes

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

Study Sites (6)

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