Artificial Intelligence-based Early Screening of Pancreatic Cancer and High Risk Tracing (ESPRIT-AI)

NCT ID: NCT04743479

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2030-12-30

Brief Summary

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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.

Detailed Description

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The study is being run by a team of dedicated physicians and researchers, led by Jin Gang, MD, Director of Department of general surgery of Shanghai Changhai Hospital. The trial will include individuals with new-onset diabetes (diagnosed within the past 3 year), 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) as well as chronic pancreatitis. Participants will undergo annual laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS). If pancreatic cancer or a pre-cancerous lesion is identified, the individual will be referred for surgery. We will also be collecting a blood sample from all participants for DNA isolation. Clinical data and biological specimens contained in this study may be used for a wide variety of future related studies to the cause, diagnosis, outcome and treatment of pancreatic cancer.

Conditions

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Pancreatic Cancer Diabetes Familial Pancreatic Cancer Pancreatic Cystic Neoplasm Chronic Pancreatitis Hereditary Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

high-resolution MRI/CT examinations

Intervention Type DIAGNOSTIC_TEST

Participants will undergo annual questionnaire survey, laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS).

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

high-resolution MRI/CT examinations

Intervention Type DIAGNOSTIC_TEST

Participants will undergo annual questionnaire survey, laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS).

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

high-resolution MRI/CT examinations

Intervention Type DIAGNOSTIC_TEST

Participants will undergo annual questionnaire survey, laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS).

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.

high-resolution MRI/CT examinations

Intervention Type DIAGNOSTIC_TEST

Participants will undergo annual questionnaire survey, laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS).

Chronic pancreatitis

Chronic pancreatitis, defined by cross-sectional imaging, endoscopic ultrasound, functional testing abnormalities OR as diagnosed by a gastroenterologist.

high-resolution MRI/CT examinations

Intervention Type DIAGNOSTIC_TEST

Participants will undergo annual questionnaire survey, laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS).

Interventions

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high-resolution MRI/CT examinations

Participants will undergo annual questionnaire survey, laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS).

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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questionnaire survey laboratory tests

Eligibility Criteria

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Inclusion Criteria

* 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:

1. New onset diabetes (diagnosed within the past 3 years)
2. Familial pancreatic cancer
3. 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)
4. Pancreatic cystic neoplasm (including IPMN, MCN)
5. Chronic pancreatitis

Exclusion Criteria

* Subject has been diagnosed with pancreatic cancer or other malignant tumors in the last 5 years;
* Subject has any medical condition that contraindicates high-resolution MRI or CT;
* Subject cannot be followed up or is participating in other clinical trials.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guo ShiWei

Associated Professor at the Institute of Pancreatic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gang Jin, M.D.

Role: STUDY_CHAIR

Department of general surgery, Changhai Hospital

Locations

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Shanghai Changhai Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Beilei Wang, M.D.

Role: CONTACT

13774238083

Shiwei Guo, M.D.

Role: CONTACT

18621500666

Facility Contacts

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Beilei Wang, M.D.

Role: primary

13774238083

References

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Kamisawa T, Wood LD, Itoi T, Takaori K. Pancreatic cancer. Lancet. 2016 Jul 2;388(10039):73-85. doi: 10.1016/S0140-6736(16)00141-0. Epub 2016 Jan 30.

Reference Type BACKGROUND
PMID: 26830752 (View on PubMed)

Lin QJ, Yang F, Jin C, Fu DL. Current status and progress of pancreatic cancer in China. World J Gastroenterol. 2015 Jul 14;21(26):7988-8003. doi: 10.3748/wjg.v21.i26.7988.

Reference Type BACKGROUND
PMID: 26185370 (View on PubMed)

Henrikson NB, Aiello Bowles EJ, Blasi PR, Morrison CC, Nguyen M, Pillarisetty VG, Lin JS. Screening for Pancreatic Cancer: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2019 Aug 6;322(5):445-454. doi: 10.1001/jama.2019.6190.

Reference Type BACKGROUND
PMID: 31386140 (View on PubMed)

Singhi AD, Koay EJ, Chari ST, Maitra A. Early Detection of Pancreatic Cancer: Opportunities and Challenges. Gastroenterology. 2019 May;156(7):2024-2040. doi: 10.1053/j.gastro.2019.01.259. Epub 2019 Feb 2.

Reference Type BACKGROUND
PMID: 30721664 (View on PubMed)

Pereira SP, Oldfield L, Ney A, Hart PA, Keane MG, Pandol SJ, Li D, Greenhalf W, Jeon CY, Koay EJ, Almario CV, Halloran C, Lennon AM, Costello E. Early detection of pancreatic cancer. Lancet Gastroenterol Hepatol. 2020 Jul;5(7):698-710. doi: 10.1016/S2468-1253(19)30416-9. Epub 2020 Mar 2.

Reference Type BACKGROUND
PMID: 32135127 (View on PubMed)

Maitra A, Sharma A, Brand RE, Van Den Eeden SK, Fisher WE, Hart PA, Hughes SJ, Mather KJ, Pandol SJ, Park WG, Feng Z, Serrano J, Rinaudo JAS, Srivastava S, Chari ST; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). A Prospective Study to Establish a New-Onset Diabetes Cohort: From the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer. Pancreas. 2018 Nov/Dec;47(10):1244-1248. doi: 10.1097/MPA.0000000000001169.

Reference Type BACKGROUND
PMID: 30325864 (View on PubMed)

Other Identifiers

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ChanghaiH-PP07

Identifier Type: -

Identifier Source: org_study_id

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