HyperglycemiaEDINCT04662879
Early Detection Initiative for Pancreatic Cancer
A study testing Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score and Abdominal imaging in people with Hyperglycemia and Diabetes Mellitus, run by Pancreatic Cancer Action Network at 2 sites in United States.
Trial summary
The Early Detection Initiative for Pancreatic Cancer is a multi-center prospective study to determine if algorithm-based screening in patients with glycemically defined new onset hyperglycemia and diabetes has the potential for earlier detection of pancreatic ductal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Hyperglycemia, Diabetes Mellitus, Pancreas Ductal Adenocarcinoma
- What is being tested?
- Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score and Abdominal imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,869 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2021to Jan 2028
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have given institutional consent for minimal risk studies.
- Patient must be ≥50 and ≤85 years of age at the time of diagnosis [index date Parameters of Diabetes Mellitus (PDM)].
- Patient must have index weight and left-window weight values available in electronic medical record (EMR).
- Patient must have hyperglycemia and/or diabetes as one of the following (all glycemic parameters, except for HbA1c, must be measured in an outpatient setting):
- Glycated hemoglobin (HbA1c) ≥ 6.5%
- OR
Show all 15Show fewer
- Any (2) PDMs on consecutive (≤90 days between PDMs) or simultaneous testing:
- Fasting Blood Glucose (FBG) ≥126 mg/dl
- Glycated hemoglobin (HbA1c) ≥ 6.5%
- Random Blood Glucose (RBG) ≥200 mg/dl
- 2 hour Post Glucose (PG) ≥ 200mg (11.1 mmol/L) during oral glucose tolerance test (OGTT)
- OR
- Any one (1) PDM present followed by an anti- diabetes medication ≤90 days after the index PDM date
- Patient must have ≥1 glycemic parameter measured in the past 91-548 days prior to the index PDM date (Left Window) without meeting inclusion criteria A, B, or C.
- For Intervention Sites, patients must meet inclusion criteria A, B, or C ≤90 days prior to enrollment.
Who cannot join
- Patient has declined institutional consent for minimal risk studies.
- Patient must not have any known past history of hyperglycemia and/or diabetes as defined by inclusion criteria A, B, or C
- Transient diabetes (e.g. gestational and steroid-induced) is not an exclusion.
- Patient must not be on ongoing active treatment for cancer, and/or carry a current diagnosis of any cancer (except non-melanoma skin cancer). Non-invasive cancer of any organ (carcinoma-in-situ/high grade dysplasia) is not an exclusion.
- Ongoing work up for suspicion of pancreatic cancer is not an exclusion.
- Patient must not have had a definitive diagnosis of pancreatic cancer prior to index PDM date.
Show all 11Show fewer
- Patient must not be on any anti-diabetes medications prior to index PDM date.
- Patient must not be on chronic or acute use of steroid medications ≤90 days prior to the index PDM date.
- Allowed: Nasal, topical steroids, oral budesonide, ophthalmic
- Patient must not have had an intra-articular steroid injection ≤ 7 days prior to the index PDM date.
- Patient must have values available in the EMR to calculate the ENDPAC score.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor College of Medicine
Houston, Texas, 77030
Kaiser Permanente Southern California, Kaiser Permanente Research
Pasadena, California, 91101
About this study
Official title: A Prospective Study of Algorithm-based Screening in Patients With Glycemically Defined New Onset Diabetes to Evaluate Risk for and Earlier Detection of Pancreatic Ductal Adenocarcinoma; Early Detection Initiative (EDI) for Pancreatic Cancer
The Early Detection Initiative for Pancreatic Cancer is a multi-center prospective study to determine if algorithm-based screening in patients with glycemically defined new onset hyperglycemia and diabetes has the potential for earlier detection of pancreatic ductal adenocarcinoma.
Read the detailed description
The Early Detection Initiative (EDI), is designed to prospectively evaluate the performance characteristics of the Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) model to enrich glycemically defined new-onset diabetes for pancreatic cancer. The study will also determine if elevated ENDPAC score occurs at a clinically meaningful lead time (>/= 4 months) before pancreatic cancer diagnosis.
Eligible patients are identified and enrolled based on a first-time elevation in fasting blood glucose parameters or glycated hemoglobin (HbA1c) to the level indicating glycemically defined new-onset diabetes as derived from records in their EMR. At sites performing the Intervention component of the study, all enrolled participants will have the Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score calculated using age, body weight and glucose or glycated hemoglobin values in their EMR. Patients with high ENDPAC score (>0) are approached for informed consent to participate in up to two imaging studies by computerized tomography (CT) scan or magnetic resonance imaging (MRI). In addition to imaging, participants will be asked to complete a study questionnaire. At sites that do not perform the Intervention component of the study, participants will be identified, enrolled, and followed by EMR data only. All enrolled participants are followed for development of PDAC.
This study is performed at locations with broad (institutional) consent for use of patient EMR information for research studies. Passive follow-up by EMR will occur for a minimum of three years following enrollment, until the planned study cutoff date January 31, 2028. Any patient that has declined participation in EMR-based research at the institution is not included in the study.
- Being tested
- Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score, Abdominal imaging
- Keywords
- New Onset Diabetes, Hyperglycemia, Diabetes Mellitus, Pancreatic Ductal Adenocarcinoma, ENDPAC score, Weight loss, Glycemically defined new onset diabetes
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) scoreOther
ENDPAC is a model to risk-stratify patients with new onset diabetes and hyperglycemia for PDAC. Score is calculated using i) age, ii) change, over past year, in body weight and iii) change, over past year, in glucose/HbA1c values obtained from the electronic medical record.
Abdominal imagingOther
Using computerized tomography (CT) scan or magnetic resonance imaging (MRI), if CT scan is contra-indicated, patients with a high ENDPAC score (>0) are approached for informed consent to participate in the imaging intervention. Imaging (CT scan) is performed at up to two time points, study baseline and approximately 3-9 months following the first imaging study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm (Site) | Experimental | Two interventions are performed:
1. Have Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score calculated, and if Score is >0,
2. Have abdominal imaging performed. Receives: Other: Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score; Other: Abdominal imaging |
| Observation Arm (Site) | No intervention | Passive follow-up by electronic medical record for study endpoints of pancreatic cancer diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the ENDPAC model
Prospectively validate the ENDPAC model.
Measured: Baseline and approximately every six months for a minimum of three years until the study cutoff date 31Jan2028
Quantify potentially clinically meaningful lead time for earlier detection of PDAC
Measure the duration from G-NOD to date of clinical diagnosis of PDAC.
Measured: Baseline and approximately every six months for a minimum of three years until the study cutoff date 31Jan2028
Secondary outcomes (4)
Evaluate the risk of PDAC in G-NOD
Estimate the risk of PDAC in G-NOD in the average risk population including potentially clinically meaningful lead time for earlier detection of PDAC.
Measured: Baseline and approximately every six months for a minimum of three years until the study cutoff date 31Jan2028
Proportion of incidental findings on imaging
Evaluate, on imaging at the time of G-NOD, the proportion with incidental findings including those that require clinical work-up.
Measured: Baseline and imaging follow-up visit, up to 9 months
Risk of PDAC by subgroups
Estimate the risk of PDAC in the study population by racial and ethnic groups.
Measured: Baseline and approximately every six months for a minimum of three years until the study cutoff date 31Jan2028
Reasons consent for intervention was declined
Evaluate the reasons invited participants decline consent for imaging intervention.
Measured: Baseline and imaging follow-up visit, up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start14 Oct 2021
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Post-enrollment consent
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8,869 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pancreatic Cancer Action Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suresh Chari, MD, Study chair, M.D. Anderson Cancer CenterAnirban Maitra, MBBS, Principal investigator, Perlmutter Cancer Center at NYU Langone HealthBechien Wu, MD, Principal investigator, Kaiser PermanenteAvinash Kambadakone-Ramesh, MD, FRCR, Principal investigator, Massachusetts General HospitalZiding Feng, PhD, Principal investigator, Fred Hutchinson Cancer CenterWilliam Fisher, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662879
- Sponsor's protocol ID
- 466
- Other IDs
- STU25020081, ONC-15162
- Acronym
- EDI
- Status last verified
- Sep 2026
- First submitted
- 20 Nov 2020
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chari ST, Wu B, Lopez C, Lustigova E, Chen Q, Van Den Eeden SK, Leimpeter AD, Fisher W, Wood A, Alexander AS, Valenta J, Vege SS, Carlson EE, Rabe KG, Hart PA, Qian L, Zhao YQ, Yosuf N, Matrisian L, Kenner B, Rinaudo JA, Maitra A, Feng Z. Risk of Pancreatic Cancer in Glycemically Defined New-Onset Diabetes: A Prospective Cohort Study. Gastroenterology. 2026 Jan;170(1):106-117. doi: 10.1053/j.gastro.2025.06.025. Epub 2025 Jul 7.
PubMed 40633624Sharma A, Kandlakunta H, Nagpal SJS, Feng Z, Hoos W, Petersen GM, Chari ST. Model to Determine Risk of Pancreatic Cancer in Patients With New-Onset Diabetes. Gastroenterology. 2018 Sep;155(3):730-739.e3. doi: 10.1053/j.gastro.2018.05.023. Epub 2018 Jun 11.
PubMed 29775599Sharma A, Smyrk TC, Levy MJ, Topazian MA, Chari ST. Fasting Blood Glucose Levels Provide Estimate of Duration and Progression of Pancreatic Cancer Before Diagnosis. Gastroenterology. 2018 Aug;155(2):490-500.e2. doi: 10.1053/j.gastro.2018.04.025. Epub 2018 Apr 30.
PubMed 29723506Chari ST, Leibson CL, Rabe KG, Ransom J, de Andrade M, Petersen GM. Probability of pancreatic cancer following diabetes: a population-based study. Gastroenterology. 2005 Aug;129(2):504-11. doi: 10.1016/j.gastro.2005.05.007.
PubMed 16083707Khan S, Safarudin RF, Kupec JT. Validation of the ENDPAC model: Identifying new-onset diabetics at risk of pancreatic cancer. Pancreatology. 2021 Apr;21(3):550-555. doi: 10.1016/j.pan.2021.02.001. Epub 2021 Feb 8.
PubMed 33583686Chen W, Butler RK, Lustigova E, Chari ST, Wu BU. Validation of the Enriching New-Onset Diabetes for Pancreatic Cancer Model in a Diverse and Integrated Healthcare Setting. Dig Dis Sci. 2021 Jan;66(1):78-87. doi: 10.1007/s10620-020-06139-z. Epub 2020 Feb 28.
PubMed 32112260Chari ST, Feng Z, Wu B, Fisher W, Kambadakone A, Zhao YQ, Maitra A, Kenner B, Matrisian LM. Heuriskance: a novel paradigm for systematic earlier detection of sporadic pancreatic cancer. J Natl Cancer Inst. 2026 Aug 1;118(8):1353-1363. doi: 10.1093/jnci/djaf291.
PubMed 41063387Chari ST, Maitra A, Matrisian LM, Shrader EE, Wu BU, Kambadakone A, Zhao YQ, Kenner B, Rinaudo JAS, Srivastava S, Huang Y, Feng Z; Early Detection Initiative Consortium. Early Detection Initiative: A randomized controlled trial of algorithm-based screening in patients with new onset hyperglycemia and diabetes for early detection of pancreatic ductal adenocarcinoma. Contemp Clin Trials. 2022 Feb;113:106659. doi: 10.1016/j.cct.2021.106659. Epub 2021 Dec 23.
PubMed 34954100
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Algorithm-based Screening in Patients With Glycemically Defined New Onset Diabetes to Evaluate Risk for and Earlier Detection of Pancreatic Ductal Adenocarcinoma; Early Detection Initiative (EDI) for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04662879
- Acronym / sponsor ID
- EDI / 466
- Keywords
- New Onset Diabetes, Hyperglycemia, Diabetes Mellitus, Pancreatic Ductal Adenocarcinoma, ENDPAC score, Weight loss, Glycemically defined new onset diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8,869 participants (actual)
- Lead sponsor
- Pancreatic Cancer Action NetworkUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Dec 2020 (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.
The Early Detection Initiative for Pancreatic Cancer is a multi-center prospective study to determine if algorithm-based screening in patients with glycemically defined new onset hyperglycemia and diabetes has the potential for earlier detection of pancreatic ductal adenocarcinoma.
Detailed description
The Early Detection Initiative (EDI), is designed to prospectively evaluate the performance characteristics of the Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) model to enrich glycemically defined new-onset diabetes for pancreatic cancer. The study will also determine if elevated ENDPAC score occurs at a clinically meaningful lead time (>/= 4 months) before pancreatic cancer diagnosis.
Eligible patients are identified and enrolled based on a first-time elevation in fasting blood glucose parameters or glycated hemoglobin (HbA1c) to the level indicating glycemically defined new-onset diabetes as derived from records in their EMR. At sites performing the Intervention component of the study, all enrolled participants will have the Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score calculated using age, body weight and glucose or glycated hemoglobin values in their EMR. Patients with high ENDPAC score (>0) are approached for informed consent to participate in up to two imaging studies by computerized tomography (CT) scan or magnetic resonance imaging (MRI). In addition to imaging, participants will be asked to complete a study questionnaire. At sites that do not perform the Intervention component of the study, participants will be identified, enrolled, and followed by EMR data only. All enrolled participants are followed for development of PDAC.
This study is performed at locations with broad (institutional) consent for use of patient EMR information for research studies. Passive follow-up by EMR will occur for a minimum of three years following enrollment, until the planned study cutoff date January 31, 2028. Any patient that has declined participation in EMR-based research at the institution is not included in the study.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Post-enrollment consent
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm (Site) | Experimental | Other: Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score, Other: Abdominal imagingTwo interventions are performed: 1. Have Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score calculated, and if Score is >0, 2. Have abdominal imaging performed. |
| Observation Arm (Site) | No intervention | –Passive follow-up by electronic medical record for study endpoints of pancreatic cancer diagnosis. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient must have given institutional consent for minimal risk studies.
- Patient must be ≥50 and ≤85 years of age at the time of diagnosis [index date Parameters of Diabetes Mellitus (PDM)].
- Patient must have index weight and left-window weight values available in electronic medical record (EMR).
- Patient must have hyperglycemia and/or diabetes as one of the following (all glycemic parameters, except for HbA1c, must be measured in an outpatient setting):
- Glycated hemoglobin (HbA1c) ≥ 6.5%
Key exclusion criteria (11 listed)
- Patient has declined institutional consent for minimal risk studies.
- Patient must not have any known past history of hyperglycemia and/or diabetes as defined by inclusion criteria A, B, or C
- Transient diabetes (e.g. gestational and steroid-induced) is not an exclusion.
- Patient must not be on ongoing active treatment for cancer, and/or carry a current diagnosis of any cancer (except non-melanoma skin cancer). Non-invasive cancer of any organ (carcinoma-in-situ/high grade dysplasia) is not an exclusion.
- Ongoing work up for suspicion of pancreatic cancer is not an exclusion.
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 |
|---|---|---|
| Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) scoreENDPAC is a model to risk-stratify patients with new onset diabetes and hyperglycemia for PDAC. Score is calculated using i) age, ii) change, over past year, in body weight and iii) change, over past year, in glucose/HbA1c values obtained from the electronic medical record. | Other | Intervention Arm (Site) |
| Abdominal imagingUsing computerized tomography (CT) scan or magnetic resonance imaging (MRI), if CT scan is contra-indicated, patients with a high ENDPAC score (>0) are approached for informed consent to participate in the imaging intervention. Imaging (CT scan) is performed at up to two time points, study baseline and approximately 3-9 months following the first imaging study. | Other | Intervention Arm (Site) |
Primary outcome
Validate the ENDPAC model
Time frame: Baseline and approximately every six months for a minimum of three years until the study cutoff date 31Jan2028
Prospectively validate the ENDPAC model.
Quantify potentially clinically meaningful lead time for earlier detection of PDAC
Time frame: Baseline and approximately every six months for a minimum of three years until the study cutoff date 31Jan2028
Measure the duration from G-NOD to date of clinical diagnosis of PDAC.
4 secondary outcomes
Evaluate the risk of PDAC in G-NOD
Time frame: Baseline and approximately every six months for a minimum of three years until the study cutoff date 31Jan2028
Proportion of incidental findings on imaging
Time frame: Baseline and imaging follow-up visit, up to 9 months
Risk of PDAC by subgroups
Time frame: Baseline and approximately every six months for a minimum of three years until the study cutoff date 31Jan2028
Reasons consent for intervention was declined
Time frame: Baseline and imaging follow-up visit, up to 9 months
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 8 Sep 2026.
- Background: PubMed 40633624Chari ST, Wu B, Lopez C, Lustigova E, Chen Q, Van Den Eeden SK, Leimpeter AD, Fisher W, Wood A, Alexander AS, Valenta J, Vege SS, Carlson EE, Rabe KG, Hart PA, Qian L, Zhao YQ, Yosuf N, Matrisian L, Kenner B, Rinaudo JA, Maitra A, Feng Z. Risk of Pancreatic Cancer in Glycemically Defined New-Onset Diabetes: A Prospective Cohort Study. Gastroenterology. 2026 Jan;170(1):106-117. doi: 10.1053/j.gastro.2025.06.025. Epub 2025 Jul 7.
- Background: PubMed 29775599Sharma A, Kandlakunta H, Nagpal SJS, Feng Z, Hoos W, Petersen GM, Chari ST. Model to Determine Risk of Pancreatic Cancer in Patients With New-Onset Diabetes. Gastroenterology. 2018 Sep;155(3):730-739.e3. doi: 10.1053/j.gastro.2018.05.023. Epub 2018 Jun 11.
- Background: PubMed 29723506Sharma A, Smyrk TC, Levy MJ, Topazian MA, Chari ST. Fasting Blood Glucose Levels Provide Estimate of Duration and Progression of Pancreatic Cancer Before Diagnosis. Gastroenterology. 2018 Aug;155(2):490-500.e2. doi: 10.1053/j.gastro.2018.04.025. Epub 2018 Apr 30.
- Background: PubMed 16083707Chari ST, Leibson CL, Rabe KG, Ransom J, de Andrade M, Petersen GM. Probability of pancreatic cancer following diabetes: a population-based study. Gastroenterology. 2005 Aug;129(2):504-11. doi: 10.1016/j.gastro.2005.05.007.
- Background: PubMed 33583686Khan S, Safarudin RF, Kupec JT. Validation of the ENDPAC model: Identifying new-onset diabetics at risk of pancreatic cancer. Pancreatology. 2021 Apr;21(3):550-555. doi: 10.1016/j.pan.2021.02.001. Epub 2021 Feb 8.
- Background: PubMed 32112260Chen W, Butler RK, Lustigova E, Chari ST, Wu BU. Validation of the Enriching New-Onset Diabetes for Pancreatic Cancer Model in a Diverse and Integrated Healthcare Setting. Dig Dis Sci. 2021 Jan;66(1):78-87. doi: 10.1007/s10620-020-06139-z. Epub 2020 Feb 28.
- Derived from this study: PubMed 41063387Chari ST, Feng Z, Wu B, Fisher W, Kambadakone A, Zhao YQ, Maitra A, Kenner B, Matrisian LM. Heuriskance: a novel paradigm for systematic earlier detection of sporadic pancreatic cancer. J Natl Cancer Inst. 2026 Aug 1;118(8):1353-1363. doi: 10.1093/jnci/djaf291.
- Derived from this study: PubMed 34954100Chari ST, Maitra A, Matrisian LM, Shrader EE, Wu BU, Kambadakone A, Zhao YQ, Kenner B, Rinaudo JAS, Srivastava S, Huang Y, Feng Z; Early Detection Initiative Consortium. Early Detection Initiative: A randomized controlled trial of algorithm-based screening in patients with new onset hyperglycemia and diabetes for early detection of pancreatic ductal adenocarcinoma. Contemp Clin Trials. 2022 Feb;113:106659. doi: 10.1016/j.cct.2021.106659. Epub 2021 Dec 23.
- Pancreatic Cancer Action Network Early Detection InitiativeLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Suresh Chari, MD study chair
M.D. Anderson Cancer Center
Anirban Maitra, MBBS principal investigator
Perlmutter Cancer Center at NYU Langone Health
Bechien Wu, MD principal investigator
Kaiser Permanente
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score and Abdominal imaging in people with Hyperglycemia and Diabetes Mellitus, run by Pancreatic Cancer Action Network at 2 sites in United States.
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 15 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Validate the ENDPAC model (time frame: Baseline and approximately every six months for a minimum of three years until the study cutoff date 31Jan2028). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04662879, which also lists 8 linked publications.
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 8 Sep 2026.