"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

Pancreatic Ductal Adenocarcinoma (PDAC) Clinical Trial

Official title:

"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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06044064
• Other study ID #: PDAC-NOD-001
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: September 1, 2027

Study information

• Verified date: October 2023
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 1, 2027
• Est. primary completion date: August 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma (PDAC)

Intervention

Procedure:
• A blood sample for CA 19-9 (cancer detection test)
A blood sample for CA 19-9 (cancer detection test) levels will be taken at baseline. Contrast CT abdomen - Pancreas protocol will be done at baseline. EUS (Endoscopic Ultrasound) under moderate sedation will be done at baseline to you. If suspicious lesion is found on examination, Fine Needle Aspiration - FNA will be done.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of PDAC at 3 years		3yrs
Secondary	• Incidence of PDAC at baseline • Incidence of resectable PDAC at baseline • Incidence of resectable PDAC at 3 years		baseline and 3yrs