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Diagnostic Test

Enhanced Screening for Pancreatic Cancer

Q: Is registration for this experiment currently open?

<p>Clinicaltrials.gov states that this trial, which launched on November 1st 2024 and was last updated on the 3rd of November 2023 is no longer recruiting participants at present. Fortunately, there are 1448 other clinical studies actively seeking individuals to join their trials.</p>

Q: What is the primary purpose of this clinical investigation?

<p>This three-year trial will be evaluated biannually, with a five year follow-up period. The primary outcome expected is the incidence rate of <a href="https://www.withpower.com/clinical-trials/pancreatic-cancer">pancreatic cancer</a> or high grade neoplasms. Secondary outcomes include Negative Predictive Value of Blood Assays, Incremental Yields of Blood-Based Assays over Standard Care Screening, and Proportion of Non Worrisome Pancreatic Lesions.</p>

Phase < 1

Recruiting

Led By Matthew Yurgelun, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with familial pancreatic cancer including: family history of exocrine pancreatic cancer in ≥2 first-degree relatives from the same side of the family, even in the absence of a known pathogenic/likely pathogenic germline variant, OR family history of exocrine pancreatic cancer in 1 affected first-degree relative and 1 second-degree relative, even in the absence of a known pathogenic/likely pathogenic germline variant, OR family history of exocrine pancreatic cancer in ≥3 first- and/or second-degree relatives from the same side of the family, even in the absence of a known pathogenic/likely pathogenic germline variant

Participants with pathogenic/likely pathogenic germline variants in STK11, and age ≥30 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

Study Summary

This trial tests if adding tests to existing screening can help find pancreatic cancer earlier in high-risk individuals.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While this trial focuses on screening rather than treatment, side effects may include discomfort from blood draws or imaging procedures, anxiety from test results, potential allergic reactions to contrast materials used in MRI/MRCP scans, and risks associated with endoscopic ultrasounds.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 30 or older with a genetic variant in STK11.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Imaging-Negative, Assay-Positive Pancreatic Cancers or High-Grade Neoplasms

Number of Imaging-Positive Pancreatic Cancers or High-Grade Neoplasms

Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms

Secondary outcome measures

Clinical Predictors of Neoplastic Development

Incremental Yield of Blood-Based Assays over Standard-of-Care Screening

Negative Predictive Value of Blood Assays

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pancreatic Cancer High-Risk ParticipantsExperimental Treatment4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Endoscopic Ultrasound

2010

Completed Phase 2

~350

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Magnetic Resonance Cholangiopancreatography

2019

N/A

~230

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

335,980 Total Patients Enrolled

Matthew Yurgelun, MDPrincipal InvestigatorDana-Farber Cancer Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is registration for this experiment currently open?

"Clinicaltrials.gov states that this trial, which launched on November 1st 2024 and was last updated on the 3rd of November 2023 is no longer recruiting participants at present. Fortunately, there are 1448 other clinical studies actively seeking individuals to join their trials."

Answered by AI

What is the primary purpose of this clinical investigation?

"This three-year trial will be evaluated biannually, with a five year follow-up period. The primary outcome expected is the incidence rate of pancreatic cancer or high grade neoplasms. Secondary outcomes include Negative Predictive Value of Blood Assays, Incremental Yields of Blood-Based Assays over Standard Care Screening, and Proportion of Non Worrisome Pancreatic Lesions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals

Matthew B. Yurgelun, MD 2023. "Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06122896.