Formation of a Precision Oncology Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 2885
- Locations
- 1
- Primary Endpoint
- Populations Requiring Financial Assistance
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
In efforts to develop an aggregation point for patient clinical data and data related to DNA sequencing in the Comprehensive Cancer Center, this registry will be developed to provide a comprehensive data store. The goal of the registry will be to collect information on the Cancer Center population undergoing next generation DNA sequencing (NGS) on their tumors or liquid biopsies.
Detailed Description
PRIMARY OBJECTIVES: I. To capture characteristics of the patient population undergoing next generation deoxyribonucleic acid (DNA) sequencing of their tumor or liquid biopsy for more efficient clinical operations by collecting data on demographics, disease, and previous treatment. II. To gather information on the number and type of patients that receive off label, standard, timeline or other experimental treatments based on the next generation sequencing (NGS) data. III. To gather data regarding the patient population that may require financial assistance. IV. To describe the patient population, in terms of demographic and clinical characteristics, who have consented to have their next generation sequencing data to be linked to their clinical records and used for future research. V. To collect overall survival for those patients with next generation sequencing data. VI. To collect outcomes and response to the standard, experimental and/or off label treatment. OUTLINE: Participants undergo collection of medical data to be used in the formation of a precision oncology registry. Medical data is collected as long as patients are receiving treatment for cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All cancer patients at Wake Forest Baptist Comprehensive Cancer Center and its satellites who are having next generation DNA sequencing ordered/performed on their tumor biopsy or surgically resected tissue and/or blood samples.
Exclusion Criteria
- •Not applicable
Outcomes
Primary Outcomes
Populations Requiring Financial Assistance
Time Frame: Approximately 2 years
To gather data regarding the patient population that may require financial assistance
Modes of Treatment for Patients
Time Frame: Approximately 2 years
To gather information on the number and type of patients that receive off label, standard, timeline or other experimental treatments based on the NGS data.
Overall Survival
Time Frame: Approximately 2 years
To collect overall survival for those patients with NGS data
Outcome and Response to Different Forms of Treatment
Time Frame: Approximately 2 years
To collect outcomes and response to the standard, experimental and/or off label treatment
Data Collection of Demographics, Disease and Previous Treatment
Time Frame: Approximately 2 years
To capture characteristics of the patient population undergoing next generation DNA sequencing of their tumor or liquid biopsy for more efficient clinical operations by collecting data on demographics, disease, and previous treatment.
Demographics Collection to Assess Patient Population
Time Frame: Approximately 2 years
To describe the patient population, in terms of demographic, who have consented to have their NGS data to be linked to their clinical records and used for future research
Clinical Characteristics of Disease
Time Frame: Approximately 2 years
To describe the patient population, in terms clinical characteristics, who have consented to have their NGS data to be linked to their clinical records and used for future research