"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

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.

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Key information

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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.

Primary outcomes

Incidence of PDAC at 3 years

Time frame: 3yrs

Secondary outcomes

• Incidence of PDAC at baseline • Incidence of resectable PDAC at baseline • Incidence of resectable PDAC at 3 years

Time frame: baseline and 3yrs

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Sep 21, 2023
Registry last updated: Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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