Clinical trial NCT06148298: Cell-Free DNA Chromatin Immunoprecipitation (ChIP) for Diagnosing Cancer
Official title: Cell-free Chromatin Immunoprecipitation (CfChIP) from Blood Plasma As a Diagnostic and Prognostic Tool in Pancreatic Ductal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer of Pancreas
Keywords: cancer
pancreas
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators want to control for approximate age and have two participants of each gender, and are looking to get 4 without Pancreatic Ductal Adenocarcinoma (PDAC), and 4 of each stage of PDAC (1 through 4).

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of c-ERBB1 in blood using Chromatin immunoprecipitation and Reverse transcription-quantitative polymerase chain reaction
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Kersten Schroeder, PhD
role: PRINCIPAL_INVESTIGATOR
References: