Medical Data Collection in the Formation of Precision Oncology Registry
- Conditions
- Cancer
- Registration Number
- NCT03874065
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2885
• 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.
Not applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Modes of Treatment for Patients 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 Approximately 2 years To collect overall survival for those patients with NGS data
Outcome and Response to Different Forms of Treatment 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 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.
Populations Requiring Financial Assistance Approximately 2 years To gather data regarding the patient population that may require financial assistance
Demographics Collection to Assess Patient Population 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Wake Forest Baptist Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States