An observational study in Carcinoma, Pancreatic Ductal, sponsored by Peking Union Medical College Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Peking Union Medical College Hospital · Observational
Study objective: The purpose of this study is to establish a prospective follow-up cohort of high-risk groups of pancreatic cancer, screen early pancreatic cancer through EUS and other means according to the existing clinical process, and evaluate each risk factors. And to prospectively collect biological samples to find molecular markers for early diagnosis of pancreatic cancer.
Study design: This is a real world, multicenter, prospective, observational cohort study.
This study intends to conduct pancreatic MR screening for the high-risk population of pancreatic cancer who meet the requirements and voluntarily participate in this study (see eligibility criteria), and retain baseline information and peripheral blood, dental plaque and stool samples.
I. For patients with solid mass of the pancreas, continue diagnosis and treatment according to the routine clinical path.
II. For patients with MPD dilatation but no clear solid pancreatic mass, EUS examination should be performed after excluding contraindications. During EUS, duodenal fluid samples were collected.
III. If solid mass is found in EUS, FNA shall be performed. If the pathological examination is positive, the patient shall be diagnosed with PDAC and treated according to the clinical routine path of PDAC. If the pathological biopsy sample is negative, repeat FNA after an appropriate interval (1 to 3 months later).
IV. If no solid mass is found in EUS, follow up the patient every 6-12 months for EUS and/or MR examination.
V. For patients with cystic lesions, EUS examination is performed after contraindications are excluded. During EUS, duodenal fluid samples were collected. If solid components such as mural nodules or "worrisome features" are found, FNA will be performed. In order to make a clear diagnosis of some cases, FNA+nCLE will be performed at the same time, and cystic fluid samples will be taken to continue diagnosis and treatment according to the clinical guidelines. If no solid lesions and "worrisome features" are found, follow up the patient every 6-12 months and perform EUS and/or MR examinations.
VI. Follow up and perform pancreatic MR examination every 12 months for those with no clear pancreatic lesions found on pancreatic MR.
The main outcome of this study was the discovery of pancreatic T1 PDAC (tumor diameter \< 2cm), or no pancreatic disease was found during the 5-year follow-up period.
The secondary outcome of this study was the discovery of other levels of PDAC, IPMN, chronic pancreatitis, autoimmune pancreatitis and other pancreatic diseases.
The samples involved in this study include baseline and follow-up samples (peripheral blood, dental plaque, stool samples), EUS-FNA solid mass aspiration tissue samples or cystic fluid samples of cystic lesions, and duodenal fluid samples collected during EUS examination. The collected samples were analyzed by transcriptomics, proteomics and next generation sequencing to study the clinical characteristics, molecular, flora markers and gene sequences related to the diagnosis of early pancreatic cancer.
50 studies on the registry are indexed under Carcinoma, Pancreatic Ductal; 9 are open to participants now.
Browse Carcinoma, Pancreatic Ductal studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
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Patients with high risks for pancreas cancer in Peking Union Medical College Hospital and other related research centers in China.
Exclusion Criteria:
Patients with solid mass of pancreas during pancreas MR examination.
Device: Endoscopic ultrasound · Procedure: EUS-Fine needle aspiration
Patients with cystic lesions or expansion of MPD during pancreas MR examination.
Device: Endoscopic ultrasound · Procedure: EUS-Fine needle aspiration
Patients with no clear focus during pancreas MR examination.
Use endoscopic ultrasound to examine the pancreatic lesions.
If solid mass of pancreas was found during EUS, EUS-FNA shall be conducted for diagnosis.
Number of Participants with T1 PDAC
Patients found with early stage PDAC, which means tumor size \< 2cm.
Time frame: 5 years
Number of Participants with no clear pancreas lesions
Patients found with no clear pancreas lesions during 5 years follow-up.
Time frame: 5 years
Number of Participants with other stages of PDAC
Patients found with any other stages of PDAC except from T1 PDAC.
Time frame: 5 years
Number of Participants with IPMN
Patients found with IPMN during the study.
Time frame: 5 years
Number of Participants with chronic pancreatitis
Patients found with chronic pancreatitis during the study.
Time frame: 5 years
Number of Participants with autoimmune pancreatitis
Patients found with autoimmune pancreatitis during the study.
Time frame: 5 years
Number of Participants with other pancreas diseases
Patients found with any other pancreas diseases except from listed above during the study.
Time frame: 5 years
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital