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

Cancer Risk Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03617939
• Other study ID #: 15-1110.cc
• Status: Recruiting
• Start date: September 16, 2015
• Est. completion date: September 2037

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Virginia Borges, MD
• Phone: 303-724-3868
• Email: virginia.borges[@]ucdenver.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: September 2037
• Est. primary completion date: September 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer Risk

Intervention

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.
• Medical Chart Reviews
Data taken directly from the patients' medical charts.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	UCHealth Memorial Hospital	Colorado Springs	Colorado
United States	UCHealth Poudre Valley Health System	Fort Collins	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Up to 20 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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