An observational study in Cancer, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-01-19.
Sponsored by Wake Forest University Health Sciences · Observational
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.
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.
Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
Exclusion Criteria: Not applicable
Collection of data from participant's medical chart
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.
Time frame: 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.
Time frame: Approximately 2 years
Populations Requiring Financial Assistance
To gather data regarding the patient population that may require financial assistance
Time frame: 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
Time frame: 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
Time frame: Approximately 2 years
Overall Survival
To collect overall survival for those patients with NGS data
Time frame: 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
Time frame: Approximately 2 years
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is terminated, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences