Pancreatic Ductal Adenocarcinoma (PDAC)NCT06044064
"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
An observational study of Pancreatic Ductal Adenocarcinoma (PDAC), run by Asian Institute of Gastroenterology, India.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- A blood sample for CA 19-9 (cancer detection test)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Known or newly detected chronic pancreatitis
- Past history of pancreatic cancer
- History of steroid use
- Contraindications for EUS
About this 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.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- A blood sample for CA 19-9 (cancer detection test)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A blood sample for CA 19-9 (cancer detection test)Procedure or surgery
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PDAC at 3 years
Measured: 3yrs
Secondary outcomes (1)
• Incidence of PDAC at baseline • Incidence of resectable PDAC at baseline • Incidence of resectable PDAC at 3 years
Measured: baseline and 3yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044064
- Sponsor's protocol ID
- PDAC-NOD-001
- Status last verified
- Oct 2023
- First submitted
- 13 Sep 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06044064
- Acronym / sponsor ID
- PDAC-NOD-001
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Known or newly detected chronic pancreatitis
- Past history of pancreatic cancer
- History of steroid use
- Contraindications for EUS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | – |
Primary outcome
Incidence of PDAC at 3 years
Time frame: 3yrs
1 secondary outcome
• Incidence of PDAC at baseline • Incidence of resectable PDAC at baseline • Incidence of resectable PDAC at 3 years
Time frame: baseline and 3yrs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma (PDAC), run by Asian Institute of Gastroenterology, India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PDAC at 3 years (time frame: 3yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023; AzTrials last refreshed its copy on 30 Oct 2026.