Medical Data Collection in the Formation of Precision Oncology Registry

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03874065
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 10,000
• Location: 1
• Anticipated Duration (Months): 197.5
• Patients Per Site Per Month: 50.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Other: Medical Chart Review

Detailed Description

PRIMARY OBJECTIVES:

1. 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.

2. 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.

3. To gather data regarding the patient population that may require financial assistance.

4. 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.

5. To collect overall survival for those patients with next generation sequencing data.

6. 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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 10000 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Formation of a Precision Oncology Registry
• Actual Study Start Date: May 17, 2019
• Anticipated Primary Completion Date: May 1, 2035
• Anticipated Study Completion Date: Nov 1, 2035

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. Populations Requiring Financial Assistance [Approximately 2 years]

   To gather data regarding the patient population that may require financial assistance

4. 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

5. 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

6. Overall Survival [Approximately 2 years]

   To collect overall survival for those patients with NGS data

7. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

• Wake Forest University Health Sciences
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Stefan Grant, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03874065
• Other Study ID Numbers: IRB00054757; NCI-2019-01293; P30CA012197; CCCWFU 04218
• First Posted: Mar 14, 2019
• Last Update Posted: Nov 26, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 26, 2021