"Effect of Screening Using Imaging (CT/ EUS) on Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in Patients With New Onset Diabetes (NOD)" - A Prospective Pilot Observational Study

October 21, 2023 updated by: Asian Institute of Gastroenterology, India

To assess whether EUS (Endoscopic Ultrasound) can serve as a valuable diagnostic tool for identifying PDAC at an early stage in individuals who have recently been diagnosed with diabetes.

Purpose: To improve the rates of early detection of pancreatic cancer.

Pancreatic ductal adenocarcinoma (PDAC) is a type of cancer that starts in the pancreas, a gland located in your abdomen. It happens when some cells in the pancreas start growing abnormally and form a cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All the consecutive patients coming to OP will be screened at AIG for the study criterias, those who are meeting them, shall be enrolled after consent. Patients will enrolled for 1 year and followed up for 3 years

Description

Inclusion Criteria:

  • Age > 50 years
  • Patients diagnosed with diabetes based on FBS/ PPBS/ HbA1C
  • Presence of atleast 1 FBS parameter measured in the past 6-18 months which was not > 125 mg/dl
  • END-PDAC score > 2

Exclusion Criteria:

  • Known or newly detected chronic pancreatitis
  • Past history of pancreatic cancer
  • History of steroid use
  • Contraindications for EUS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of PDAC at 3 years
Time Frame: 3yrs
3yrs

Secondary Outcome Measures

Outcome Measure
Time Frame
• Incidence of PDAC at baseline • Incidence of resectable PDAC at baseline • Incidence of resectable PDAC at 3 years
Time Frame: baseline and 3yrs
baseline and 3yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 21, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDAC-NOD-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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