Cell-Free DNA Chromatin Immunoprecipitation (ChIP) For Diagnosing Cancer

Study Overview

Cell-Free DNA Chromatin Immunoprecipitation (ChIP) for Diagnosing Cancer

The goal of this research is to use chromatin immunoprecipitation, a method used to study protein-DNA interaction, as a tool to diagnose and prognose pancreatic ductal adenocarcinoma in human samples. This is a Non-Human Subject Research study. All participants are de-identified.

Pancreatic ductal adenocarcinoma (PDAC) is a neoplastic disease which accounts for ⊐% of pancreatic malignancies," and has a 5-year survival rate of only 9%. The dismal nature of the PDAC diagnosis, which has a median survival time of about one year, can be attributed in part to late detection. In fact, the Cancer of Pancreas Screening-5 study demonstrated a 73.3% survival rate in participants whose PDAC was found early through surveillance via MRI and endoscopic ultrasound. This eightfold increase in survival rate suggests the inherent efficacy of PDAC screening, however, with the median cost of a full MRI being about $2,000, there is a significant barrier to entry for PDAC screening. As a result, finding a cost-effective alternative to PDAC screening could improve survival rates and lower costs, both directly and indirectly. Liquid biopsy could prove to be a valuable tool in the early diagnosis of PDAC, as it provides a non-invasive way to detect the presence of a disease state such as PDAC. Chromatin immunoprecipitation (ChIP), a type of liquid biopsy used to study protein-DNA interaction, is a promising method at the forefront of cancer research, and has been proven to be capable of detecting tumor-specific transcriptional activity. Additionally, the assay has shown promise in diagnosis and prognosis of disease state. Currently, few (if any) modalities of liquid biopsy in pancreatic cancer use ChIP, and other forms of liquid biopsy have proven to lack sensitivity and specificity. Thus, the aim of this research is to utilize the ChIP assay as a diagnostic and prognostic tool in PDAC by detecting and quantifying tumoral gene expression.

Cancer of Pancreas

OTHER: Non-Human Subject Research study.

STUDY00005188

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-11-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-12-03
First Submitted that Met QC Criteria 2023-11-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-12-06
First Posted (ACTUAL) 2023-11-28	Results First Posted N/A	Last Verified 2024-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Pancreatic Ductal Adenocarcinoma	OTHER: Non-Human Subject Research study. This is a Non-Human Subject Research study. There is no intervention. All participants are de-identified.

Participant Group/Arm

Intervention/Treatment

: Pancreatic Ductal Adenocarcinoma

OTHER: Non-Human Subject Research study.

This is a Non-Human Subject Research study. There is no intervention. All participants are de-identified.

Primary Outcome Measures	Measure Description	Time Frame
Level of c-ERBB1 in blood using Chromatin immunoprecipitation and Reverse transcription-quantitative polymerase chain reaction	Chromatin immunoprecipitation is a method used to study the interaction between DNA and proteins. This makes it a valuable tool for detecting disease state in samples as it allows us to study gene regulation. To put this into practice, DNA is crosslinked to proteins and precipitated out of solution using an antibody. In this case, anti-H3K36me3 was used as it is a marker for active gene regulation which allows for separation of actively transcribed genes. This is synonymous to selecting for a certain disease state that is ongoing. Once this is done, Reverse transcription-quantitative polymerase chain reaction (RT-qPCR) is run on the sample to select for EGFR c-ERBB1, which is an epithelial growth factor (EGFR) mutation which is present in 93% of PDAC cases. Analysis of relative levels of c-ERBB1 should allow for us to diagnose and prognose different stages of PDAC.	1 year

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Amoy Fraser, PhD, CCRP, PMP

Phone Number: 4072668742

Email: amoy.fraser@ucf.edu

Study Contact Backup

Name: Erica Martin, B.S.

Phone Number: 4072668742

Email: erica.martin@ucf.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

18 years old or older
Pancreatic cancer patients

Children may not register
Persons who are unable to consent may not register

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Kersten Schroeder, PhD, University of Central Florida

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record