NCT04743479

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Dec 2020Dec 2030

Study Start

First participant enrolled

December 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Expected
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

5.1 years

First QC Date

February 3, 2021

Last Update Submit

August 31, 2023

Conditions

Pancreatic CancerDiabetesFamilial Pancreatic CancerPancreatic Cystic NeoplasmChronic PancreatitisHereditary Pancreatitis

Keywords

ScreeningEarly DiagnosisArtificial IntelligencePancreatic Cancer

Outcome Measures

Primary Outcomes (2)

  • Incidence

    Determine incidence of pancreatic cancer or precursor lesions among high risk individuals.

    5 years

  • Hazard ratio (HR)

    Assesses the influence of risk factors on the incidence of pancreatic cancer or precursor lesions among high risk individuals.

    5 years

Secondary Outcomes (3)

  • Survival time

    5 years

  • HR

    5 years

  • Diagnostic yield

    5 years

Study Arms (5)

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.

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

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

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.

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.

Diagnostic Test: high-resolution MRI/CT examinations

Interventions

high-resolution MRI/CT examinationsDIAGNOSTIC_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).

Also known as: questionnaire survey, laboratory tests
Chronic pancreatitisFamilial pancreatic cancerInherited syndromes associated with pancreatic cancerNew Onset DiabetesPancreatic Cystic Neoplasm

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

High risk individuals of pancreatic cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, 200433, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 26830752BACKGROUND

  • 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.

    PMID: 26185370BACKGROUND

  • 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.

    PMID: 31386140BACKGROUND

  • 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.

    PMID: 30721664BACKGROUND

  • 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.

    PMID: 32135127BACKGROUND

  • 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.

    PMID: 30325864BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Patients in this study will have the option of donating blood for biobanking, approximately 10cc of plasma and 10cc of serum. Further, samples that are routinely collected for diagnostic purposes may be collected and banked at the time of their clinically routine procedure. If a patient consents to the use of extra material for research purposes, the biological samples will be banked and the blood, and/or pancreatic juice/cystic fluid, tissues, and saliva will be used for identification and characterization of potential biomarkers from de-identified samples.

MeSH Terms

Conditions

Pancreatic NeoplasmsDiabetes MellitusPancreatic carcinoma, familialPancreatitis, ChronicHereditary pancreatitisDisease

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPancreatitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Gang Jin, M.D.

    Department of general surgery, Changhai Hospital

    STUDY CHAIR

Central Study Contacts

Beilei Wang, M.D.

CONTACT

13774238083lilly_wang@126.com

Shiwei Guo, M.D.

CONTACT

18621500666gestwa@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor at the Institute of Pancreatic Surgery

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 8, 2021

Study Start

December 1, 2020

Primary Completion

December 30, 2025

Study Completion (Estimated)

December 30, 2030

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)