Medical Data Collection in the Formation of Precision Oncology Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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Formation of a Precision Oncology Registry

Conditions
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Cancer

Intervention / Treatment
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* Other: Medical Chart Review


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Medical Chart Review|Collection of data from participant's medical chart|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data Collection of Demographics, Disease and Previous Treatment | 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. | Approximately 2 years | 
| Modes of Treatment for Patients | 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. | Approximately 2 years | 
| Populations Requiring Financial Assistance | To gather data regarding the patient population that may require financial assistance | Approximately 2 years | 
| Demographics Collection to Assess Patient Population | 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 | Approximately 2 years | 
| Clinical Characteristics of Disease | 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 | Approximately 2 years | 
| Overall Survival | To collect overall survival for those patients with NGS data | Approximately 2 years | 
| Outcome and Response to Different Forms of Treatment | To collect outcomes and response to the standard, experimental and/or off label treatment | Approximately 2 years |