A Screening Program to Improve the Early Detection of Sporadic Pancreatic Cancer in Individuals With a High-Risk of Developing Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

This clinical trial studies a new screening program to improve the early detection of sporadic pancreatic cancer in individuals with a high risk of developing pancreatic cancer. Pancreatic cancer remains one of the deadliest solid tumors, characterized by a long phase without symptoms followed by rapid progression once clinically evident. Despite advancements in treatment, the survival rate for pancreatic cancer remains low. Research has helped to identify a subset of individuals with a markedly high short-term risk for developing pancreatic cancer, which includes adults aged 50 and older with glycemically-defined new-onset diabetes and an Enriching New-Onset Diabetes for Pancreatic Cancer (ENDPAC) score ≥ 3. However, current practice guidelines do not provide clear pathways for surveillance or early detection. The screening program in this trial combines repeated contrast-enhanced computed tomography (CT) scans using artificial intelligence (AI) and blood draws. Contrast-enhanced CT is an imaging technique which creates a series of detailed pictures of areas inside the body; the pictures are created by a computer linked to an x-ray machine and a contrast agent is used to enhance the images. The images are then reviewed using AI, which may make it easier to spot cancer earlier on the CT scans than with the human eye. Studying samples of blood in the laboratory from high-risk individuals may help doctors understand more about why they may develop pancreatic cancer. This may be an effective way to screen high-risk individuals and improve the early detection of sporadic pancreatic cancer.

Intervention public domain (ClinicalTrials.gov)

Procedure: Biospecimen Collection. Undergo blood sample collection

Intervention public domain (ClinicalTrials.gov)

Procedure: Computed Tomography with Contrast. Undergo contrast-enhanced abdominal CT

Intervention public domain (ClinicalTrials.gov)

Other: Electronic Health Record Review. Undergo electronic medical record (EMR) surveillance

Arm public domain (ClinicalTrials.gov)

Group A1 (CT, blood, EMR surveillance) (experimental): Patients undergo contrast-enhanced abdominal CT and blood sample collection at baseline, 6 months, and 12 months in the absence of unacceptable toxicity. Patients also undergo EMR surveillance for PDA diagnosis for up to 36 months.

Arm public domain (ClinicalTrials.gov)

Group A2 (blood, EMR surveillance) (experimental): Patients undergo blood sample collection at baseline, 6 months, and 12 months in the absence of unacceptable toxicity. Patients also undergo EMR surveillance for PDA diagnosis for up to 36 months.

Arm public domain (ClinicalTrials.gov)

Group B (EMR surveillance) (active comparator): Patients undergo EMR surveillance for PDA diagnosis for up to 36 months.

Primary outcome public domain (ClinicalTrials.gov)

Recruitment yield (Feasibility). Will assess the feasibility of protocol implementation as defined by recruitment yield (% of flagged high-risk individuals who consent). Descriptive statistics will be used to summarize feasibility endpoints. Time frame: Up to 3 years.

Primary outcome public domain (ClinicalTrials.gov)

Imaging adherence rates (Feasibility). Will assess the feasibility of protocol implementation as defined by imaging adherence rates (% completing 3 scheduled computed tomography scans). Descriptive statistics will be used to summarize feasibility endpoints. Time frame: Up to 3 years.

Primary outcome public domain (ClinicalTrials.gov)

Blood collection success rates (Feasibility). Will assess the feasibility of protocol implementation as defined by blood collection success rates (% completing 3 scheduled blood collections). Descriptive statistics will be used to summarize feasibility endpoints. Time frame: Up to 3 years.

Primary outcome public domain (ClinicalTrials.gov)

Completeness of electronic medical record (EMR)-based follow-up (Feasibility). Will assess the feasibility of protocol implementation as defined by completeness of EMR-based follow-up (% of participants with outcome ascertainment). Descriptive statistics will be used to summarize feasibility endpoints. Time frame: Up to 3 years.

Secondary outcome public domain (ClinicalTrials.gov)

Time from glycemically-defined new-onset diabetes (gNOD) onset to pancreatic ductal adenocarcinoma (PDA) diagnosis. Time frame: Up to 3 years.

Secondary outcome public domain (ClinicalTrials.gov)

Proportion of PDAs diagnosed at stage 0/I. Time frame: Up to 3 years.

Secondary outcome public domain (ClinicalTrials.gov)

Rate and type of incidental findings requiring downstream evaluation. Time frame: Up to 3 years.

Secondary outcome public domain (ClinicalTrials.gov)

Artificial intelligence (AI)-detected imaging signatures and standard radiologist interpretations. Time frame: Up to 3 years.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: * Age ≥ 50 and ≤ 85 years * Glycemically-defined new-onset diabetes (gNOD) with onset ≤ 180 days preceding enrollment * Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score ≥ 3, based on validated risk stratification models * Provide written or remote informed consent Exclusion Criteria: * Prior diagnosis of pancreatic ductal adenocarcinoma (PDA) * Known hereditary cancer syndromes (e.g., BRCA1/2, Lynch syndrome, Peutz-Jeghers) * Prior history of pancreatic surgery * Pancreatic cyst surveillance at time of registration * Contraindications to contrast-enhanced CT imaging per standard clinical practice at time of registration

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 100 participants (estimated).