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| Name | Class |
|---|---|
| Beijing Hospital | OTHER_GOV |
| Tongji Hospital | OTHER |
| The First Affiliated Hospital of Xiamen University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solid mass | Patients with solid mass of pancreas during pancreas MR examination. |
| |
| Cystic lesions | Patients with cystic lesions or expansion of MPD during pancreas MR examination. |
| |
| No clear focus | Patients with no clear focus during pancreas MR examination. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic ultrasound | Device | Use endoscopic ultrasound to examine the pancreatic lesions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with T1 PDAC | Patients found with early stage PDAC, which means tumor size < 2cm. | 5 years |
| Number of Participants with no clear pancreas lesions | Patients found with no clear pancreas lesions during 5 years follow-up. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with other stages of PDAC | Patients found with any other stages of PDAC except from T1 PDAC. | 5 years |
| Number of Participants with IPMN | Patients found with IPMN during the study. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with high risks for pancreas cancer in Peking Union Medical College Hospital and other related research centers in China.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi Wu, M.D. | Contact | +86 13683296860 | wxpumch@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xi Wu, M.D. | Peking Union Medical College Hospital | Study Director |
| Shengyu Zhang, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Yuheng Zhang, MD candidate |
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| ID | Term |
|---|---|
| D021441 | Carcinoma, Pancreatic Ductal |
| ID | Term |
|---|---|
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D019160 | Endosonography |
| D061765 | Endoscopic Ultrasound-Guided Fine Needle Aspiration |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Baseline sample includes 20ml blood sample, 1 dental plaque sample and 1 stool sample. Follow-up samples include 10mL blood sample, duodenal fluid samples collected during EUS examination and remaining samples of pancreatic puncture tissue and/or cyst fluid during EUS.
| EUS-Fine needle aspiration | Procedure | If solid mass of pancreas was found during EUS, EUS-FNA shall be conducted for diagnosis. |
|
| 5 years |
| Number of Participants with chronic pancreatitis | Patients found with chronic pancreatitis during the study. | 5 years |
| Number of Participants with autoimmune pancreatitis | Patients found with autoimmune pancreatitis during the study. | 5 years |
| Number of Participants with other pancreas diseases | Patients found with any other pancreas diseases except from listed above during the study. | 5 years |
| Peking Union Medical College Hospital |
| Principal Investigator |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D044963 |
| Biopsy, Fine-Needle |
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D061705 | Image-Guided Biopsy |
| D013048 | Specimen Handling |
| D018084 | Ultrasonography, Interventional |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |