[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07030348":3,"trial-entities:NCT07030348":83,"trial-summary:NCT07030348":89},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":33,"sex":38,"minimum_age":39,"maximum_age":22,"healthy_volunteers":40,"eligibility_criteria":41,"std_ages":45,"locations":48,"central_contacts":74,"overall_officials":80,"references":81,"see_also_links":82},"NCT07030348","DHP_Bio","Early Diagnosis of Pancreatic Cancer Duodenal Fluid-Based Biomarker Exploratory Study","RECRUITING","2026-12-31","2025-06","2025-06-22","2024-01-02","Do Hyun Park","OTHER",false,"Purpose Pancreatic cancer is the fourth leading cancer-related mortality disease in the United States, with a five-year survival rate of 11%, and only 10 15% of all pancreatic cancer patients are operable or borderline operable.\n\nTherefore, there is an unmet need for early diagnosis of pancreatic cancer; however, biomarkers related to this are not well understood. This study aims to identify biomarkers for the early diagnosis of pancreatic cancer through duodenal pancreatic juice, which can be easily obtained through an endoscopy.","Pancreatic cancer is the fourth leading cancer-related mortality disease in the United States, with a five-year survival rate of 11%, which is a very poor prognosis, and only 10-15% of all pancreatic cancer patients are operable or borderline operable.\n\nTherefore, there is an unmet need for early diagnosis of pancreatic cancer; however, the biomarkers of humoral fluids associated with the early diagnosis of pancreatic cancer are not well understood.\n\nDuodenal pancreatic fluids can be easily obtained through an endoscopy and contain a large amount of pancreatic fluid secreted by the pancreas, which is known to be a candidate of biomarkers for early diagnosis of pancreatic cancer.\n\nHowever, there have been few studies using duodenal fluids in Korea. This study aims to prospectively analyze biomarkers for early diagnosis of pancreatic cancer using duodenal fluids obtained by endoscopy in pancreatic and non-pancreatic cancer groups.",[18,19],"Pancreatic Cancers","Pancreatic Diseases",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},263,"ESTIMATED",[],[29],{"measure":30,"description":31,"timeFrame":32},"Identification of Biomarkers for Early Pancreatic Cancer Detection","Area Under the Receiver Operating Characteristic Curve (AUC) and 95% Confidence Interval (CI) of candidate biomarkers in the training cohort. If the AUC falls within ±5% of the target value (0.94), the optimal cutoff value for pancreatic cancer differentiation will be reported using Youden's Index.","Up to 1 year from baseline",[34],{"measure":35,"description":36,"timeFrame":37},"External Validation Using U.S. Samples","Area under the ROC curve (AUC) of candidate biomarkers in the U.S. validation cohort using cut-off values derived from the Korean training cohort","Up to 2 year from baseline","ALL","19 Years",true,{"inclusion":42,"exclusion":43,"raw_text":44},[],[],"Inclusion Criteria:\n\nAmong the patients requiring gastro-duodenal endoscopy, endoscopic ultrasound, or ERCP for medical purposes, the pancreatic cancer group should meet the criteria numbered 1, 2, and either 3 or 4.\n\n1. Be at least 19 years old.\n2. Have completed the informed consent for planned upper endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography before the duodenal fluid collection.\n3. A biopsy with proven stage I-IV pancreatic ductal adenocarcinoma (PDAC).\n4. Suspected pancreatic cancer on imaging and scheduled for an endoscopic ultrasound-guided pancreatic biopsy.\n\nThe non-pancreatic cancer group should meet the criteria numbered 1, 2, and either 3 or 4.\n\n1. Be at least 19 years old.\n2. Have completed the informed consent for planned upper endoscopy, endoscopic ultrasound, or endoscopic retrograde cholangiopancreatography before the duodenal fluid collection.\n3. Patients with pancreatic cystic tumors or patients with acute or chronic pancreatitis.\n4. No evidence of a pancreatic disease.\n\nExclusion Criteria:\n\nThe exclusion criteria for the pancreatic cancer and the non-pancreatic cancer groups will be:\n\n1. Innate or post-surgical anatomy that precludes direct sampling of duodenal fluid.\n2. Hemodynamically unstable and unable to have an endoscopy performed.\n3. A large amount of ascites fluid that is not controlled and unable to have an endoscopy performed.\n4. A coagulation disorder that cannot be corrected and unable to have an endoscopy performed.",[46,47],"ADULT","OLDER_ADULT",[49,58,66],{"facility":50,"status":7,"city":51,"state":52,"zip":53,"country":54,"geoPoint":55},"University of Colorado Hospital","Aurora","Colorado","80045","United States",{"lat":56,"lon":57},39.72943,-104.83192,{"facility":59,"status":7,"city":60,"state":61,"zip":62,"country":54,"geoPoint":63},"Cleveland Clinic","Cleveland","Ohio","44195",{"lat":64,"lon":65},41.4995,-81.69541,{"facility":67,"status":7,"city":68,"zip":69,"country":70,"geoPoint":71},"Asan Medical Center","Seoul","05505","South Korea",{"lat":72,"lon":73},37.566,126.9784,[75],{"name":76,"role":77,"phone":78,"email":79},"HyeJin Song, CRC","CONTACT","+82-2-2045-3825","asangicrc@gmail.com",[],[],[],{"nct_id":4,"conditions":84,"biomarkers":88},[85,86,87],"Pancreatic Carcinoma","Pancreatic Cystic Tumor","Pancreatitis",[],{"nct_id":4,"found":40,"summary":90,"prompt_version":99},{"design":91,"status":92,"heading":6,"summary":93,"follow_up":94,"word_count":95,"commitments":96,"compensation":97,"drugs_mentioned":98},"This is an observational study planning to enroll 263 participants. It is not a treatment study, but rather aims to identify biomarkers.","completed","This observational study is looking for ways to find pancreatic cancer earlier, as it often has a poor prognosis. Researchers are trying to identify biomarkers (biological signs) in duodenal fluid (fluid from the first part of your small intestine) that could help with early diagnosis. This fluid can be collected during routine procedures like endoscopy. The study aims to compare these biomarkers in people with and without pancreatic cancer. You may be able to join if you are at least 19 years old and are already scheduled for an upper endoscopy, endoscopic ultrasound, or ERCP (endoscopic retrograde cholangiopancreatography) for medical reasons. The main goal is to find these biomarkers within one year from when you start the study.","Participants will be followed for up to one year from the start of the study to identify biomarkers.",118,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]