"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
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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 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 |
- 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.
- Incidence of PDAC at 3 years [ Time Frame: 3yrs ]
- • Incidence of PDAC at baseline • Incidence of resectable PDAC at baseline • Incidence of resectable PDAC at 3 years [ Time Frame: baseline and 3yrs ]
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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 |
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
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |