Medical Data Collection in the Formation of Precision Oncology Registry

Wake Forest University (WFU)

Status: Terminated

Conditions: Cancer

Treatments: Other: Medical Chart Review

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03874065

P30CA012197 (U.S. NIH Grant/Contract)

IRB00054757

NCI-2019-01293 (Registry Identifier)

CCCWFU 04218 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,885 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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