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

Recruiting

• Conditions: Cancer Risk
• Interventions: Procedure: Biospeciman Collection; Other: Survey Assessments; Other: Medical Chart Reviews

• Registration Number: NCT03617939
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2015-09-16
• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16
• Primary Completion: 2035-09
• Study Completion: 2037-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biospeciman and Data Collection	Survey Assessments	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.
Biospeciman and Data Collection	Medical Chart Reviews	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.
Biospeciman and Data Collection	Biospeciman 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.

Primary Outcome Measures

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

Trial Locations

Locations (6)

UCHealth Memorial Hospital Central; 🇺🇸 Colorado Springs, Colorado, United States

UCHealth Memorial Hospital North; 🇺🇸 Colorado Springs, Colorado, United States

Highlands Ranch Medical Center; 🇺🇸 Highlands Ranch, Colorado, United States

Cherry Creek Medical Center; 🇺🇸 Denver, Colorado, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

UCHealth Poudre Valley Health System; 🇺🇸 Fort Collins, Colorado, United States