"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

Pancreatic Ductal Adenocarcinoma (PDAC)

Intervention / Treatment

Procedure: A blood sample for CA 19-9 (cancer detection test)

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

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