Pancreatic CancerESPRIT-AINCT04743479
Artificial Intelligence-based Early Screening of Pancreatic Cancer and High Risk Tracing (ESPRIT-AI)
An observational study of Pancreatic Cancer and Diabetes, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Pancreatic Cancer, Diabetes, Familial Pancreatic Cancer
- What is being tested?
- high-resolution MRI/CT examinations
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: High risk individuals of pancreatic cancer
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Changhai Hospital
Shanghai, 200433
Beilei Wang, M.D., 13774238083, lilly_wang@126.com
Gang Jin, M.D.
About this study
Official title: Artificial Intelligence-based Health Information Management System and Key Technology Study of Early Screening and Hierarchical Diagnosis and Treatment of Pancreatic Cancer
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.
Read the detailed description
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
- Pancreatic Cancer, Diabetes, Familial Pancreatic Cancer, Pancreatic Cystic Neoplasm, Chronic Pancreatitis, Hereditary Pancreatitis
- Being tested
- high-resolution MRI/CT examinations
- Keywords
- Screening, Early Diagnosis, Artificial Intelligence, Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms, Diabetes Mellitus, Pancreatic carcinoma, familial, Pancreatitis, Chronic, Hereditary pancreatitis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-resolution MRI/CT examinationsDiagnostic test
Also called questionnaire survey, laboratory tests
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: high-resolution MRI/CT examinations | |
| 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 Receives: Diagnostic Test: high-resolution MRI/CT examinations | |
| 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 Receives: Diagnostic Test: high-resolution MRI/CT examinations | |
| 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. Receives: Diagnostic Test: high-resolution MRI/CT examinations | |
| Chronic pancreatitis | Chronic pancreatitis, defined by cross-sectional imaging, endoscopic ultrasound, functional testing abnormalities OR as diagnosed by a gastroenterologist. Receives: Diagnostic Test: high-resolution MRI/CT examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
Determine incidence of pancreatic cancer or precursor lesions among high risk individuals.
Measured: 5 years
Hazard ratio (HR)
Assesses the influence of risk factors on the incidence of pancreatic cancer or precursor lesions among high risk individuals.
Measured: 5 years
Secondary outcomes (3)
Survival time
Calculate survival time from point of diagnosis and treatment among the identified patients with pancreatic cancer.
Measured: 5 years
HR
Assesses the influence of risk factors on survival time among the identified patients with pancreatic cancer.
Measured: 5 years
Diagnostic yield
Determine diagnostic yield (sensitivity, specificity, positive/negative predictive value and accuracy) of AI-based surveillance program to predict early stage pancreatic cancer.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start1 Dec 2020
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo ShiWei, Changhai Hospital
- Investigators
- Gang Jin, M.D., Study chair, Department of general surgery, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743479
- Sponsor's protocol ID
- ChanghaiH-PP07
- Acronym
- ESPRIT-AI
- Status last verified
- Aug 2023
- First submitted
- 3 Feb 2021
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26830752Lin 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.
PubMed 26185370Henrikson 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.
PubMed 31386140Singhi 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.
PubMed 30721664Pereira 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.
PubMed 32135127Maitra 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.
PubMed 30325864
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-based Health Information Management System and Key Technology Study of Early Screening and Hierarchical Diagnosis and Treatment of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04743479
- Acronym / sponsor ID
- ESPRIT-AI / ChanghaiH-PP07
- Conditions
- Pancreatic Cancer, Diabetes, Familial Pancreatic Cancer, Pancreatic Cystic Neoplasm, Chronic Pancreatitis, Hereditary Pancreatitis
- Keywords
- Screening, Early Diagnosis, Artificial Intelligence, Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| New Onset Diabetes | – | Diagnostic Test: high-resolution MRI/CT examinationsNew 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 | – | Diagnostic Test: high-resolution MRI/CT examinationsFamilial 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 | – | Diagnostic Test: high-resolution MRI/CT examinationsFamily 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 | – | Diagnostic Test: high-resolution MRI/CT examinationsPancreatic Cystic Neoplasm, including intraductal papillary mucinous neoplasms (IPMN) and mucinous cystic neoplasms (MCN), which are defined by endoscopic ultrasound or serial imaging. |
| Chronic pancreatitis | – | Diagnostic Test: high-resolution MRI/CT examinationsChronic pancreatitis, defined by cross-sectional imaging, endoscopic ultrasound, functional testing abnormalities OR as diagnosed by a gastroenterologist. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High risk individuals of pancreatic cancer
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-resolution MRI/CT examinationsAlso: questionnaire survey, laboratory testsParticipants 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). | Diagnostic test | Chronic pancreatitis, Familial pancreatic cancer, Inherited syndromes associated with pancreatic cancer, New Onset Diabetes, Pancreatic Cystic Neoplasm |
Primary outcome
Incidence
Time frame: 5 years
Determine incidence of pancreatic cancer or precursor lesions among high risk individuals.
Hazard ratio (HR)
Time frame: 5 years
Assesses the influence of risk factors on the incidence of pancreatic cancer or precursor lesions among high risk individuals.
3 secondary outcomes
Survival time
Time frame: 5 years
HR
Time frame: 5 years
Diagnostic yield
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Background: PubMed 26830752Kamisawa 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.
- Background: PubMed 26185370Lin 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.
- Background: PubMed 31386140Henrikson 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.
- Background: PubMed 30721664Singhi 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.
- Background: PubMed 32135127Pereira 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.
- Background: PubMed 30325864Maitra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gang Jin, M.D. study chair
Department of general surgery, Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Diabetes, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beilei Wang, M.D. (13774238083, lilly_wang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04743479, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.