Clinical trial NCT03874065: Medical Data Collection in the Formation of Precision Oncology Registry
Official title: Formation of a Precision Oncology Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-03-14
Enrollment: 2885
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Data Collection of Demographics, Disease and Previous Treatment
timeFrame: Approximately 2 years
measure: Modes of Treatment for Patients
timeFrame: Approximately 2 years
measure: Populations Requiring Financial Assistance
timeFrame: Approximately 2 years
measure: Demographics Collection to Assess Patient Population
timeFrame: Approximately 2 years
measure: Clinical Characteristics of Disease
timeFrame: Approximately 2 years
measure: Overall Survival
timeFrame: Approximately 2 years
measure: Outcome and Response to Different Forms of Treatment
timeFrame: Approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stefan Grant, MD
role: PRINCIPAL_INVESTIGATOR
References: