Medical Data Collection in the Formation of Precision Oncology Registry

Formation of a Precision Oncology Registry

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.

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Other: Medical Chart Review

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.

• Study Type: Observational
• Enrollment (Actual): 2885

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The population of the registry will be comprised of Wake Forest Baptist Comprehensive Cancer Center cancer patients undergoing NGS from their tumor or liquid biopsy.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Stefan Grant, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2019
• Primary Completion (Actual): January 11, 2024
• Study Completion (Actual): January 11, 2024

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 11, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB00054757; P30CA012197 (U.S. NIH Grant/Contract); NCI-2019-01293 (Registry Identifier: Clinical Trial Reporting Program); CCCWFU 04218 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No reference to any individual participant will appear in reports, presentations, or publications that may arise from the collection of this data. The data could be used for a research study. All data provided for research will be completely deidentified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No