Enhanced Screening for Pancreatic Cancer

Recruiting at 1 trial location

Overseen By Matthew Yurgelun, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Pancreatic cancer, Metastatic cancer, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

5000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for enhanced screening for pancreatic cancer?

Research suggests that endoscopic ultrasound (EUS) and magnetic resonance imaging (MRI) are effective for early detection of pancreatic cancer, especially in high-risk individuals. EUS is particularly promising as it allows for tissue sampling, which can help in diagnosing and understanding the cancer better. ^{1 2 3 4 5}

How is the Enhanced Screening for Pancreatic Cancer treatment different from other treatments?

This treatment is unique because it combines advanced imaging techniques like endoscopic ultrasound (EUS) and magnetic resonance imaging (MRI) with blood tests to detect pancreatic cancer early, especially in high-risk individuals. EUS is particularly promising as it allows for tissue sampling, which can help in diagnosing and understanding the molecular profile of the cancer. ^{2 3 4 5 6}

What is the purpose of this trial?

The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.

Research Team

Matthew Yurgelun, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults at high risk of pancreatic cancer due to genetic factors or family history. Eligible participants have specific gene variants linked to increased risk and meet certain age criteria, which vary based on their genetic status. They must be able to give informed consent and tolerate MRI/ MRCP and endoscopic ultrasound procedures. Those with active pancreatic cancer, any metastatic cancer, or who are pregnant are excluded.

Inclusion Criteria

I have a genetic variant linked to pancreatic cancer and a family history of the disease.

My family has a history of pancreatic cancer across multiple close relatives.

I am currently being monitored for pancreatic cancer as recommended by my doctor.

Exclusion Criteria

I am under 18 years old.

I have been diagnosed with pancreatic cancer.

I have cancer that has spread to other parts of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline visit with questionnaires, blood tests, and pancreas screening procedure (EUS or MRI/MRCP)

1 visit

1 visit (in-person)

Active Screening

Pancreas screening procedures (EUS or MRI/MRCP) and collection of blood, stool, and saliva samples every 12 months; blood tests and questionnaires every 6 months

3 years

Annual visits (in-person), biannual visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after active screening, with annual collection of blood and stool samples

5 years

Annual visits (in-person)

Long-term Follow-up

Review of medical records and annual collection of blood and stool samples for up to 20 years

Up to 20 years

Treatment Details

Interventions

• Endoscopic Ultrasound
• Magnetic Resonance Cholangiopancreatography
• Magnetic Resonance Imaging
• Screening Blood Tests

Trial Overview The study tests if adding blood tests and symptom reviews to regular screening can detect pancreatic cancer earlier in high-risk individuals. It involves standard imaging techniques like Magnetic Resonance Imaging (MRI), Magnetic Resonance Cholangiopancreatography (MRCP), and Endoscopic Ultrasound as part of the screening process.

Participant Groups

Group I: Pancreatic Cancer High-Risk Participants Experimental Treatment 4 Interventions

Study procedures will be conducted as follows: * Baseline visit with questionnaires, blood tests, and pancreas screening procedure (EUS or MRI/MRCP). * Pancreas screening procedures (Endoscopic ultrasound (EUS), or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples) every 12 months. * Blood tests and questionnaires every 6 months. * Follow up visits.

Endoscopic Ultrasound is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Endoscopic Ultrasound for:

• Diagnosis and surveillance of pancreatic cysts
• Staging of pancreatic cancer
• Evaluation of the pancreas and bile ducts

Approved in United States as Endoscopic Ultrasound for:

• Diagnosis and surveillance of pancreatic cysts
• Staging of pancreatic cancer
• Evaluation of the pancreas and bile ducts
• Characterization and biopsy of focal lesions in the upper gastrointestinal tract

Approved in Canada as Endoscopic Ultrasound for:

• Diagnosis and surveillance of pancreatic cysts
• Staging of pancreatic cancer
• Evaluation of the pancreas and bile ducts

Approved in Japan as Endoscopic Ultrasound for:

• Diagnosis and surveillance of pancreatic cysts
• Staging of pancreatic cancer
• Evaluation of the pancreas and bile ducts

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Findings from Research

Ultrasound and computed tomography are the most effective methods for screening small pancreatic carcinomas due to their ease of use and accuracy, while MR cholangiopancreatography and endoscopic ultrasound are recommended for further evaluation when initial imaging suggests a tumor.

In a follow-up study of 77 patients with resected pancreatic carcinoma, those with tumors limited to the duct epithelium (mostly <1 cm) achieved a remarkable 100% 5-year survival rate, highlighting the importance of early detection in improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of small pancreatic ductal adenocarcinoma. Ariyama, J., Suyama, M., Satoh, K., et al.[2022]

Endoscopic retrograde cholangiopancreatography (ERCP) is the most sensitive diagnostic test for pancreatic carcinoma at 92%, outperforming computed tomography (CT) and ultrasound, which have sensitivities of 83% and 74%, respectively.

The combination of serum CA 19-9 testing and ultrasound is recommended as the initial diagnostic approach for suspected pancreatic carcinoma, as it improves sensitivity and helps avoid unnecessary invasive procedures like diagnostic laparotomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis of pancreatic carcinoma. Imaging techniques and tumor markers. Niederau, C., Grendell, JH.[2022]

The study highlights that screening asymptomatic patients at increased risk for pancreatic cancer using MRI/magnetic resonance cholangiopancreatography or endoscopic ultrasound can lead to earlier diagnoses.

There is a need for further collaboration to identify the best population for screening and to improve current methods for pancreatic cancer surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Detection of Pancreatic Cancer in High-Risk Individuals: Where Do We Go From Here? Hart, PA.[2020]

Screening for pancreatic cancer (PC) is crucial for high-risk patients, as it can lead to the early detection of premalignant lesions like high-grade pancreatic intraepithelial neoplasia and intraductal papillary mucinous neoplasm.

Endoscopic ultrasound (EUS) and magnetic resonance imaging are the most accurate imaging techniques for detecting PC, with EUS offering the added benefit of tissue sampling for diagnosis and molecular profiling, making it a promising tool in specialized research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New strategies for the early detection of pancreatic cancer. Petrone, MC., Arcidiacono, PG.[2016]

The IMMray PanCan-d test shows a high negative predictive value (NPV) of 99%, indicating it is effective at ruling out pancreatic cancer in individuals, particularly in high-risk groups.

However, the positive predictive value (PPV) is significantly lower, ranging from 12% to 52% depending on how borderline results are classified, suggesting that while the test is reliable for negative results, its ability to confirm a diagnosis of pancreatic cancer is less certain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of the IMMray PanCan-d Test in High-Risk Individuals Undergoing Pancreatic Surveillance: Pragmatic Data and Lessons Learned. Katona, BW., Worthington, C., Clay, D., et al.[2023]

Recent studies suggest that factors like aspirin and oleic acid may offer protective benefits against pancreatic cancer, which is known for its poor prognosis.

Advancements in diagnostic techniques, such as endoscopic ultrasound (EUS) and intratumoral confocal endomicroscopy, are improving the accuracy of pancreatic cancer diagnosis and treatment, including the promising method of delivering gemcitabine directly into tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The latest advances in pancreatic tumors]. Lariño Noia, J.[2012]

References

1. United States pubmed.ncbi.nlm.nih.gov

Imaging of small pancreatic ductal adenocarcinoma. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Diagnosis of pancreatic carcinoma. Imaging techniques and tumor markers. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Early Detection of Pancreatic Cancer in High-Risk Individuals: Where Do We Go From Here? [2020]

4. England pubmed.ncbi.nlm.nih.gov

New strategies for the early detection of pancreatic cancer. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Outcomes of the IMMray PanCan-d Test in High-Risk Individuals Undergoing Pancreatic Surveillance: Pragmatic Data and Lessons Learned. [2023]

6. Spain pubmed.ncbi.nlm.nih.gov

[The latest advances in pancreatic tumors]. [2012]