Observational Registry Evaluating the Clinical Impact of the Blood-Based Biomarker Test for Early-Stage Pancreatic Ductal Adenocarcinoma

NCT07805681 | Not Yet Recruiting

• 1 other identifier: ASSURE-12
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational registry is to examine the changes made to pancreatic cancer surveillance management following the real-world clinical use of PancreaSure testing among individuals at increased risk for pancreatic ductal adenocarcinoma. The main question it aims to answer is, does surveillance management and intent change following the return of PancreaSure binary results.

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer Stage I; Pancreatic Cancer Stage II; Cancer Diagnosis

Keywords

Pancreatic Cancer Diagnosis; Pancreatic Cancer; PDAC; Early Detection; Pancreatic Cancer Stage I; Pancreatic Cancer Stage II; Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer Detection

Outcome Measures

Primary Outcomes (1)

• Change in documented pancreatic surveillance management planning and intent following return of PancreaSure results, assessed within a predefined post-result window of 7-14 days following tR, relative to the documented pre-test surveillance plan and stra

  7-14 days following return of results

Secondary Outcomes (3)

• Describing patterns of PancreaSure test utilization in clinical practice

  0-12 Months Following Enrollment

• Downstream clinical actions and follow-through

  0-12 months following enrollment

• Patient-reported outcomes

  0- 12 months following enrollment

Other Outcomes (3)

• Downstream healthcare utilization patterns potentially associated with PancreaSure testing

  From date PancreaSure is prescribed (t0) through 24 months after t0.

• Clinical Outcomes During Follow-Up

  From the date PancreaSure is prescribed (t0) through 24 months after t0; survival status will be assessed 12 months after PDAC diagnosis when available.

• Economic Outcomes Associated with PancreaSure Testing and Downstream Care

  From the date PancreaSure is prescribed (t0) through 24 months after t0.

Study Arms (1)

High Risk Individuals

Individuals who are considered at high-risk for developing pancreatic ductal adenocarcinoma.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults (\>45 years) at elevated risk for PDAC or otherwise identified for PDAC early detection testing by their clinician. Factors for high risk include: * Family history in ≥ 2 first-degree relatives, or * Known pathogenic germline mutation (BRCA1/2, CDKN2A, PALB2, ATM, STK11, PRSS1), or * Pancreatic cystic lesion, or * New-onset diabetes with additional risk factors, or * Clinician discretion

You may qualify if:

• Able to provide informed written consent and complete the survey in English or Spanish
• \>45 years of age
• PancreaSure ordered as part of routine clinical care.
• At elevated risk for PDAC or is deemed appropriate for PDAC early detection testing based on:
• Family history in ≥ 2 first-degree relatives, or
• Known pathogenic germline mutation (BRCA1/2, CDKN2A, PALB2, ATM, STK11, PRSS1), or
• Pancreatic cystic lesion, or
• New-onset diabetes with additional risk factors, or
• Clinician discretion

You may not qualify if:

• Prior diagnosis of PDAC or other active malignancy within 3 years (except non-melanoma skin cancer).
• Participation in interventional investigational studies that may bias test use.
• Inability or unwillingness to comply with follow-up schedule.

Sponsors & Collaborators

• Immunovia, Inc.: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: September 4, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 4, 2026

Record last verified: 2026-09