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"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

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ClinicalTrials.gov Identifier: NCT06044064
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : October 24, 2023
Sponsor:
Information provided by (Responsible Party):
Asian Institute of Gastroenterology, India

Study Description
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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
Pancreatic Ductal Adenocarcinoma (PDAC) Procedure: A blood sample for CA 19-9 (cancer detection test)

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
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
Estimated Study Start Date : December 1, 2023
Estimated Primary Completion Date : August 1, 2027
Estimated Study Completion Date : September 1, 2027
Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Incidence of PDAC at 3 years [ Time Frame: 3yrs ]

Secondary Outcome Measures :
  1. • Incidence of PDAC at baseline • Incidence of resectable PDAC at baseline • Incidence of resectable PDAC at 3 years [ Time Frame: baseline and 3yrs ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT06044064    
Other Study ID Numbers: PDAC-NOD-001
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: October 24, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms