Medical Data Collection in the Formation of Precision Oncology Registry

NCT03874065 | Terminated DMC

• 4 other identifiers: IRB00054757NCI-2019-01293P30CA012197CCCWFU 04218
• Study Type: observational
• Target: 2,885
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• Populations Requiring Financial Assistance

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

  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

  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

  Approximately 2 years

• Overall Survival

  To collect overall survival for those patients with NGS data

  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

  Approximately 2 years

Interventions

Medical Chart Review OTHER

Collection of data from participant's medical chart

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Stefan Grant, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 14, 2019
• Study Start: May 17, 2019
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)