Artificial Intelligence-based Health Information Management System and Key Technology Study of Early Screening and Hierarchical Diagnosis and Treatment of Pancreatic Cancer

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

Pancreatic cancer is one of the most fatal malignancies with a 5-year survival rate of only \ 6%\[1\]. The reasons for this high mortality rate can be attributed to several factors, of which perhaps the most important is delayed diagnosis due to vague symptoms and consequently missed opportunities for surgical resection. Therefore, the ability to detect pancreatic cancer at an early, more curable stage is urgently needed. Identifying risk factors and biomarkers of early pancreatic cancer could facilitate screening for individuals at higher than average risk and expedite the diagnosis in individuals with symptoms and substantially improve an individual's chance of surviving the disease. Thus, the investigators propose this longitudinal study entitled, Artificial Intelligence-based Early Screening of Pancreatic Cancer and High Risk Tracing (ESPRIT-AI) in order to generate clinical data sets and bank serial blood specimens of high risk individuals.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: f
View:

• Subject is able and willing to provide informed consent and sign an informed consent form.

• Subject or authorized representative must be willing to complete a detailed questionnaire.

• Subject must meet one of the following criteria:

‣ New onset diabetes (diagnosed within the past 3 years)

⁃ Familial pancreatic cancer

⁃ Inherited syndromes associated with pancreatic cancer (including Hereditary pancreatitis, Familial atypical multiple mole and melanoma syndrome, Hereditary nonpolyposis colon cancer, Peutz-Jeghers syndrome, Hereditary breast and ovarian cancer syndromes, etc)

⁃ Pancreatic cystic neoplasm (including IPMN, MCN)

⁃ Chronic pancreatitis

Locations
Other Locations
China
Shanghai Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Beilei Wang, M.D.
lilly_wang@126.com
13774238083
Backup
Shiwei Guo, M.D.
gestwa@163.com
18621500666
Time Frame
Start Date: 2020-12-01
Estimated Completion Date: 2030-12-30
Participants
Target number of participants: 5000
Treatments
New Onset Diabetes
New Onset Diabetes must meet one of the following criteria:~1. Documented diabetes diagnosed within the past 3 years.~2. Definite new-onset diabetes based on recent fasting blood glucose (FBG) values ≥126 mg/dl (7.0 mmol/L) or Hemoglobin A1c (HbA1c) ≥ 6.5%. All glycemic parameters must be measured in an outpatient setting.
Familial pancreatic cancer
Familial pancreatic cancer must meet one of the following criteria:~1. ≥ 2 blood relatives with pancreatic cancer (includes 1st-3rd degree relatives)~2. One 1st degree relative with PDAC diagnosed before age 60
Inherited syndromes associated with pancreatic cancer
Family history includes with inherited syndromes associated with pancreatic cancer ( ≥ 2 blood relative, includes 1st-3rd degree relatives).~Inherited syndromes must meet one of the following criteria:~1. Hereditary pancreatitis~2. Familial atypical multiple mole and melanoma syndrome~3. Hereditary nonpolyposis colon cancer~4. Peutz-Jeghers syndrome~5. Hereditary breast and ovarian cancer syndromes
Pancreatic Cystic Neoplasm
Pancreatic Cystic Neoplasm, including intraductal papillary mucinous neoplasms (IPMN) and mucinous cystic neoplasms (MCN), which are defined by endoscopic ultrasound or serial imaging.
Chronic pancreatitis
Chronic pancreatitis, defined by cross-sectional imaging, endoscopic ultrasound, functional testing abnormalities OR as diagnosed by a gastroenterologist.
Sponsors
Leads: Changhai Hospital

This content was sourced from clinicaltrials.gov

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