Cell-Free DNA CHIP for Diagnosing Cancer

Sponsor
University of Central Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT06148298
Collaborator
(none)
24
1
11.3
2.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Non-Human Subject Research study.

Detailed Description

Pancreatic ductal adenocarcinoma (PDAC) is a neoplastic disease which accounts for "90% 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
24 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Cell-free Chromatin Immunoprecipitation (CfChIP) From Blood Plasma as a Diagnostic and Prognostic Tool in Pancreatic Ductal Adenocarcinoma
Actual Study Start Date :
May 24, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Level of c-ERBB1 in blood using Chromatin immunoprecipitation and Reverse transcription-quantitative polymerase chain reaction [1 year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18 years old or older

  • Pancreatic cancer patients

Exclusion Criteria:
  • Children may not register

  • Persons who are unable to consent may not register

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Central Florida Orlando Florida United States 32816

Sponsors and Collaborators

  • University of Central Florida

Investigators

  • Principal Investigator: Kersten Schroeder, PhD, University of Central Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Central Florida
ClinicalTrials.gov Identifier:
NCT06148298
Other Study ID Numbers:
  • STUDY00005188
First Posted:
Nov 28, 2023
Last Update Posted:
Nov 28, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Central Florida
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 28, 2023