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

• Sponsor: Asian Institute of Gastroenterology, India (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06044064
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 45

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Ductal Adenocarcinoma (PDAC)	Procedure: A blood sample for CA 19-9 (cancer detection test)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: "Effect of Screening Using Imaging (CT/ EUS) on Early Detection of PDAC in Patients With New Onset Diabetes (NOD)" - A Prospective Pilot Observational Study
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2027
• Anticipated Study Completion Date: Sep 1, 2027

Outcome Measures

Primary Outcome Measures

1. Incidence of PDAC at 3 years [3yrs]

Secondary Outcome Measures

1. • Incidence of PDAC at baseline • Incidence of resectable PDAC at baseline • Incidence of resectable PDAC at 3 years [baseline and 3yrs]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Asian Institute of Gastroenterology, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Asian Institute of Gastroenterology, India
• ClinicalTrials.gov Identifier: NCT06044064
• Other Study ID Numbers: PDAC-NOD-001
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Adenocarcinoma

Study Results

No Results Posted as of Sep 21, 2023