Medical Data Collection in the Formation of Precision Oncology Registry

Cancer Clinical Trial

Official title:

Formation of a Precision Oncology Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03874065
• Other study ID #: IRB00054757
• Secondary ID: NCI-2019-01293P3
• Status: Terminated
• Start date: May 17, 2019
• Est. completion date: January 11, 2024

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 2885
• Est. completion date: January 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Medical Chart Review
Collection of data from participant's medical chart

Locations

Country	Name	City	State
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Populations Requiring Financial Assistance	To gather data regarding the patient population that may require financial assistance	Approximately 2 years
Primary	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
Primary	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
Primary	Overall Survival	To collect overall survival for those patients with NGS data	Approximately 2 years
Primary	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