[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06148298":3,"trial-entities:NCT06148298":78,"trial-summary:NCT06148298":82},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":24,"healthy_volunteers":15,"eligibility_criteria":43,"std_ages":51,"locations":54,"central_contacts":63,"overall_officials":72,"references":76,"see_also_links":77},"NCT06148298","STUDY00005188","Cell-Free DNA Chromatin Immunoprecipitation (ChIP) for Diagnosing Cancer","Cell-free Chromatin Immunoprecipitation (CfChIP) from Blood Plasma As a Diagnostic and Prognostic Tool in Pancreatic Ductal Adenocarcinoma","RECRUITING","2025-05","2024-12","2024-12-06","2023-05-24","University of Central Florida","OTHER",false,"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.\n\nThis is a Non-Human Subject Research study. All participants are de-identified.","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.",[19],"Cancer of Pancreas",[21,22],"cancer","pancreas","OBSERVATIONAL",null,[],{"count":27,"type":28},24,"ESTIMATED",[30],{"type":14,"name":31,"description":32,"armGroupLabels":33},"Non-Human Subject Research study.","This is a Non-Human Subject Research study. There is no intervention. All participants are de-identified.",[34],"Pancreatic Ductal Adenocarcinoma",[36],{"measure":37,"description":38,"timeFrame":39},"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",[],"ALL","18 Years",{"inclusion":44,"exclusion":47,"raw_text":50},[45,46],"18 years old or older","Pancreatic cancer patients",[48,49],"Children may not register","Persons who are unable to consent may not register","Inclusion Criteria:\n\n* 18 years old or older\n* Pancreatic cancer patients\n\nExclusion Criteria:\n\n* Children may not register\n* Persons who are unable to consent may not register",[52,53],"ADULT","OLDER_ADULT",[55],{"facility":13,"status":8,"city":56,"state":57,"zip":58,"country":59,"geoPoint":60},"Orlando","Florida","32816","United States",{"lat":61,"lon":62},28.53834,-81.37924,[64,69],{"name":65,"role":66,"phone":67,"email":68},"Amoy Fraser, PhD, CCRP, PMP","CONTACT","4072668742","amoy.fraser@ucf.edu",{"name":70,"role":66,"phone":67,"email":71},"Erica Martin, B.S.","erica.martin@ucf.edu",[73],{"name":74,"affiliation":13,"role":75},"Kersten Schroeder, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":79,"biomarkers":81},[80],"Pancreatic Carcinoma",[],{"nct_id":4,"found":83,"summary":84,"prompt_version":94},true,{"design":85,"status":86,"heading":87,"summary":88,"follow_up":89,"word_count":90,"commitments":91,"compensation":92,"drugs_mentioned":93},"This is an observational study that is not specified by phase, with a planned enrollment of 24 participants.","completed","Cell-Free DNA Chromatin Immunoprecipitation (ChIP) for Diagnosing Pancreatic Cancer","This study is looking at a new way to diagnose pancreatic cancer using a method called chromatin immunoprecipitation (ChIP). This technique examines how proteins and DNA interact in the body. Researchers hope to use this method to find pancreatic cancer early and predict how it might progress. This is a non-human subject research study, meaning it uses de-identified (anonymous) samples from people who have already been diagnosed with pancreatic cancer. The main goal is to measure the level of a specific marker called c-ERBB1 in blood samples using ChIP and another test called RT-qPCR. The study aims to enroll 24 participants. You may be able to participate if you are 18 years or older and have pancreatic cancer.","The primary endpoint, measuring c-ERBB1 levels, will be assessed at 1 year.",118,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]