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RecruitingNCT06148298Updated Dec 6, 2024

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

An observational study in Cancer of Pancreas, sponsored by University of Central Florida. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.

Sponsored by University of Central Florida · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
24
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cancer of Pancreas

Keywords

  • cancer
  • pancreas
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

This study's planned enrollment of 24 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

University of Central Florida is the lead sponsor of 99 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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).

Inclusion criteria

  • 18 years old or older
  • Pancreatic cancer patients

Exclusion criteria

Exclusion Criteria:

  • Children may not register
  • Persons who are unable to consent may not register
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Study design

Observational model
Other
Time perspective
Other
Enrollment
24 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pancreatic Ductal Adenocarcinoma

    Other: Non-Human Subject Research study.

Interventions

  • OtherNon-Human Subject Research study.

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • University of Central Florida
    Orlando, Florida 32816, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06148298
Lead sponsor
University of Central Florida
Responsible party
Sponsor
First posted
Nov 28, 2023
Start date
May 24, 2023
Primary completion
May 2025 (estimated)
Completion
May 2025 (estimated)
Last update
Dec 6, 2024

Study contacts

Amoy Fraser, PhD, CCRP, PMP
Contact
amoy.fraser@ucf.edu
4072668742
Erica Martin, B.S.
Contact
erica.martin@ucf.edu
4072668742
Kersten Schroeder, PhD
principal investigator · University of Central Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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