Diabetes Screening for Early Detection of Pancreatic Cancer
(EDI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if the Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score can help detect pancreatic cancer earlier in individuals with newly diagnosed high blood sugar or diabetes. Participants will either have their score calculated and possibly undergo abdominal imaging, or they will be observed through their medical records. It suits individuals recently diagnosed with high blood sugar or diabetes who have no history of cancer treatment. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to earlier detection of pancreatic cancer.
Do I need to stop my current medications for this trial?
The trial requires that you are not on any anti-diabetes medications before the start date. If you are currently taking such medications, you may need to stop them to participate.
What prior data suggests that this algorithm-based screening is safe for early detection of pancreatic cancer?
Research has shown that the ENDPAC score helps identify individuals at higher risk for pancreatic cancer, particularly those with new-onset diabetes. Studies have not identified any direct safety concerns with calculating this score. It assesses risk using age, recent weight changes, and diabetes status.
Abdominal imaging occurs if the ENDPAC score exceeds a certain level and is generally safe. Research indicates that imaging can effectively detect pancreatic cancer early in high-risk individuals. Standard imaging techniques have not reported major safety issues. However, like any medical test, minor side effects may occur, such as slight discomfort or rare allergic reactions to the contrast dye used in some scans.
Overall, these methods are well-tolerated and focus on early detection rather than direct treatment.12345Why are researchers excited about this trial?
Researchers are excited about the ENDPAC score because it provides a new way to screen for pancreatic cancer by identifying patients with new-onset diabetes who might be at higher risk. Unlike standard care, which usually involves waiting for symptoms to appear before conducting imaging tests, the ENDPAC score allows for proactive abdominal imaging based on a calculated risk score. This approach could lead to earlier detection of pancreatic cancer, potentially improving outcomes by catching the disease at a more treatable stage.
What evidence suggests that this trial's treatments could be effective for early detection of pancreatic cancer?
In this trial, participants in the intervention arm will have their Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score calculated. Research has shown that the ENDPAC score can identify individuals with new-onset diabetes who are at higher risk for pancreatic cancer. Studies indicate that an ENDPAC score of 3 or higher significantly increases the likelihood of early pancreatic cancer detection, even up to six months before a typical diagnosis. Early findings suggest that this score can identify a group who might benefit more from further screening.
If the ENDPAC score exceeds 0, participants will also undergo abdominal imaging. Previous studies found signs of pancreatic cancer in nearly half of the patients who had scans six to twelve months before an official diagnosis. Together, these methods aim to detect pancreatic cancer earlier, potentially leading to better outcomes for those at risk. Participants in the observation arm will have passive follow-up through electronic medical records for study endpoints of pancreatic cancer diagnosis.678910Who Is on the Research Team?
Anirban Maitra, MBBS
Principal Investigator
M.D. Anderson Cancer Center
Avinash Kambadakone-Ramesh, MD, FRCR
Principal Investigator
Massachusetts General Hospital
Suresh Chari, MD
Principal Investigator
M.D. Anderson Cancer Center
Bechien Wu, MD
Principal Investigator
Kaiser Permanente
Ziding Feng, PhD
Principal Investigator
Fred Hutchinson Cancer Center
Are You a Good Fit for This Trial?
This trial is for people aged 50-85 who've recently developed high blood sugar or diabetes, as shown in their medical records. They must consent to the study and not be on any cancer treatments, have no history of hyperglycemia/diabetes or pancreatic cancer diagnosis before the study start date, and not be taking steroids.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants with high ENDPAC scores undergo imaging studies and complete a study questionnaire
Observation
Participants are followed by electronic medical record for study endpoints of pancreatic cancer diagnosis
Follow-up
Participants are monitored for safety and effectiveness after intervention
What Are the Treatments Tested in This Trial?
Interventions
- Abdominal imaging
- Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score
Trial Overview
The trial tests if a special score (ENDPAC) combined with abdominal imaging can find pancreatic cancer early in those newly diagnosed with high blood sugar or diabetes. It's a randomized controlled trial across multiple centers.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
Passive follow-up by electronic medical record for study endpoints of pancreatic cancer diagnosis.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pancreatic Cancer Action Network
Lead Sponsor
Fred Hutchinson Cancer Center
Collaborator
National Institutes of Health (NIH)
Collaborator
Citations
Early prediction of pancreatic cancer from new-onset ...
The key step towards early detection of PC is to identify well-tailored cohorts of people at high risk, to whom a suitable combination of non-invasive ...
Cost-Effectiveness of Pancreatic Cancer Screening in New ...
This economic evaluation examines the cost-effectiveness of 3 screening strategies for pancreatic ductal adenocarcinoma among individuals ...
Early Detection Initiative 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 ...
Pancreatic Cancer Screening in New-onset and Deteriorating ...
The 5-year survival of screen-detected cancers was 73%. The Pancreatic Cancer Early Detection consortium is a prospective, international study that expands ...
Early Detection Initiative: A randomized controlled trial of ...
In a recent study of MDCT scans done up to 36 months prior to PDAC diagnosis, findings suggestive of PDAC were seen in the nearly half the patients 6–12 months ...
Aspects and outcomes of surveillance for individuals at high ...
Several studies have investigated the outcomes of HRIs undergoing pancreatic cancer surveillance. A meta-analysis by Signoretti et al.
Pancreatic cancer screening and outcomes in patients with ...
Results: Of 194 patients who had relevant genetic testing results, 128 (65.98%) underwent abdominal imaging, while 66 (34.02%) did not. Among ...
Pancreatic Cancer Surveillance and Survival of High-Risk ...
One- and 5-year survival probabilities were 95% (95% CI, 86%-100%) and 61% (95% CI, 40%-93%), respectively, in the high-risk individuals with screen-detected ...
Variant: 1 Adult. High-risk screening for pancreatic ductal ...
Another study suggests that within the 3 to 6 months prior to diagnosis, a contrast-enhanced CT may be 86% sensitive in the identification of findings ...
Pancreatic Cancer Screening: A Narrative Review
The best prognosis is seen in patients with T1 PC, with a 5-year survival rate of 35%-67% after pancreatic resection., However, <10% of the operated patients ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.