Cancer of the PancreasVERIFINCT06947395
Clinical Validation of a Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer (VERIFI)
An observational study of Cancer of the Pancreas and Pancreatic Cancer, run by Immunovia, Inc. at 6 sites in United States.
Trial summary
This is a case-control study to clinically validate the performance of PancreaSure, a protein biomarker test, to differentiate Stage I and Stage II pancreatic ductal adenocarcinoma (PDAC) patient samples from samples acquired from control patients not diagnosed with PDAC but at increased risk of disease due to… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cancer of the Pancreas, Pancreatic Cancer, Pancreas Neoplasms
- What is being tested?
- PancreaSure
- How many people
- 386 participants
- Where
- 6 sitesUnited States
- Study dates
- 11 Feb 2025to 7 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Samples will be retrospectively obtained under the Immunovia PanDetect, PanFam, or unique institutional protocols for sample collection through high-risk PDAC surveillance programs.
Who may be able to join
- Informed consent available
- > 45 years of age
- PDAC cases
- Treatment-naïve, pathologically confirmed PDAC Stage I or Stage II
- Sporadic or familial/genetic PDAC
- Controls
Show all 9Show fewer
- Individuals at high risk for PDAC because of their familial and/or genetic history
- Individuals at high risk for PDAC because of pancreatic cysts between 1.0cm and 3.0cm in diameter.
- Controls will be selected to have similar demographic features (age/gender) to PDAC patients
Who cannot join
- Prior treatment for PDAC (i.e., prior resection, radiotherapy, or chemotherapy)
- Current immunosuppressive (e.g., systemic steroid therapy) or chemotherapy
- Major surgery or significant trauma within 12 weeks prior to blood sample collection
- Non-PDAC malignancies within 3 years prior to sample collection squamous or basal cell skin carcinoma is not an exclusion criteria)
- Control patients who currently have
- biliary obstruction secondary to gallstones
- prior diagnosis or imaging evidence of chronic pancreatitis
- cystic pancreatic lesions >3.0 cm in diameter or showing worrisome features according to Fukuoka Consensus Guidelines.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
UT Southwestern Medical Center
Dallas, Texas, 75235
Regional One Health
Memphis, Tennessee, 38103
New York University Langone Health
New York, New York, 10016
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213-2582
Virginia Commonwealth University
Richmond, Virginia, 23284
HonorHealth Clinical Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: VERIFI: A Multicenter, Case-Control Clinical Validation Study of the Multiplex Blood Protein Biomarker Test, PancreaSure, for Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in High-Risk Patients
This is a case-control study to clinically validate the performance of PancreaSure, a protein biomarker test, to differentiate Stage I and Stage II pancreatic ductal adenocarcinoma (PDAC) patient samples from samples acquired from control patients not diagnosed with PDAC but at increased risk of disease due to familial/genetic history or clinical symptoms.
Read the detailed description
This is the second case-control study to clinically validate the multi- analyte biomarker diagnostic model, PancreaSure. Serum samples will be collected for analysis from patients with pancreatic ductal adenocarcinoma (PDAC) Stages I and II and non-PDAC controls of similar demographics who were at increased risk of PDAC because of their familial or genetic history. Investigators and patients will not receive individual patient results, therefore patient care will not be impacted by test results. Analysis of blood samples will be conducted in Immunovia's laboratory in Durham, NC by personnel who are blinded to subject data. Biomarker results will be analyzed using a predefined (locked) algorithm with predefined (locked) cut-off resulting in a positive/negative test outcome.
- Conditions
- Cancer of the Pancreas, Pancreatic Cancer, Pancreas Neoplasms, Pancreatic Carcinoma Stage I, Pancreatic Carcinoma Stage II
- Being tested
- PancreaSure
- Keywords
- Early Detection of Cancer, Cancer Diagnostic, Early Detection of Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancreaSureDiagnostic test
Serum-based biomarker test comprised of ELISA-based analyte readings of 4 protein biomarkers (ICAM-1, TIMP1, THSB1, and CTSD) and CA19-9 summed by a mathematical algorithm with associated coefficients where a pre-defined cutoff establishes a positive or negative detection of PDAC.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Ductal Adenocarcinoma (PDAC) Stage I and Stage II Cases | PDAC case samples will be obtained from patients with newly diagnosed, treatment- naive PDAC (Stages I and II). PDAC cases will include patients with familial/genetic or sporadic disease identified by the institution or referred to it for clinical management. Receives: Diagnostic Test: PancreaSure | |
| High-Risk Controls | Controls will consist of individuals who are at increased risk for PDAC because of their family history, known germline variants predisposing to PDAC, or the presence of pancreatic cystic lesions consistent with IPMNs. Note that cystic lesions between 1 and 3 cm are included in this study because PDAC risk with lesions less than 1 cm is quite low while lesions greater than 3 cm or with worrisome features by Fukuoka Consensus Guidelines have an appreciable risk of harboring an undiagnosed PDAC. All controls must have pancreatic imaging studies showing no evidence of PDAC within 6 months of sample collection. Receives: Diagnostic Test: PancreaSure |
What is being measured
The primary outcome is the main question the study is designed to answer.
PancreaSure Sensitivity
Determine the sensitivity of PancreaSure in the classification of serum samples from patients diagnosed with PDAC as positive for PDAC, in a study sample containing both PDAC and control samples.
Measured: Baseline
Secondary outcomes (2)
PancreaSure Specificity
Determine specificity of PancreaSure in the classification of serum samples from control subjects as negative for PDAC, in a study sample containing both PDAC and control samples
Measured: Baseline
Performance versus CA19-9 alone
Determine performance (sensitivity and specificity) of PancreaSure compared to CA19-9 alone in the overall population
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start11 Feb 2025
- Primary completion24 Mar 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunovia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricio Polanco, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947395
- Sponsor's protocol ID
- VERIFI-11
- Acronym
- VERIFI
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient test results will not be shared with patients.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VERIFI: A Multicenter, Case-Control Clinical Validation Study of the Multiplex Blood Protein Biomarker Test, PancreaSure, for Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in High-Risk Patients
- ClinicalTrials.gov ID
- NCT06947395
- Acronym / sponsor ID
- VERIFI / VERIFI-11
- Conditions
- Cancer of the Pancreas, Pancreatic Cancer, Pancreas Neoplasms, Pancreatic Carcinoma Stage I, Pancreatic Carcinoma Stage II
- Keywords
- Early Detection of Cancer, Cancer Diagnostic, Early Detection of Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Immunovia, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a case-control study to clinically validate the performance of PancreaSure, a protein biomarker test, to differentiate Stage I and Stage II pancreatic ductal adenocarcinoma (PDAC) patient samples from samples acquired from control patients not diagnosed with PDAC but at increased risk of disease due to familial/genetic history or clinical symptoms.
Detailed description
This is the second case-control study to clinically validate the multi- analyte biomarker diagnostic model, PancreaSure. Serum samples will be collected for analysis from patients with pancreatic ductal adenocarcinoma (PDAC) Stages I and II and non-PDAC controls of similar demographics who were at increased risk of PDAC because of their familial or genetic history. Investigators and patients will not receive individual patient results, therefore patient care will not be impacted by test results. Analysis of blood samples will be conducted in Immunovia's laboratory in Durham, NC by personnel who are blinded to subject data. Biomarker results will be analyzed using a predefined (locked) algorithm with predefined (locked) cut-off resulting in a positive/negative test outcome.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Ductal Adenocarcinoma (PDAC) Stage I and Stage II Cases | – | Diagnostic Test: PancreaSurePDAC case samples will be obtained from patients with newly diagnosed, treatment- naive PDAC (Stages I and II). PDAC cases will include patients with familial/genetic or sporadic disease identified by the institution or referred to it for clinical management. |
| High-Risk Controls | – | Diagnostic Test: PancreaSureControls will consist of individuals who are at increased risk for PDAC because of their family history, known germline variants predisposing to PDAC, or the presence of pancreatic cystic lesions consistent with IPMNs. Note that cystic lesions between 1 and 3 cm are included in this study because PDAC risk with lesions less than 1 cm is quite low while lesions greater than 3 cm or with worrisome features by Fukuoka Consensus Guidelines have an appreciable risk of harboring an undiagnosed PDAC. All controls must have pancreatic imaging studies showing no evidence of PDAC within 6 months of sample collection. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Samples will be retrospectively obtained under the Immunovia PanDetect, PanFam, or unique institutional protocols for sample collection through high-risk PDAC surveillance programs.
Key inclusion criteria (9 listed)
- Informed consent available
- > 45 years of age
- PDAC cases
- Controls
Key exclusion criteria (8 listed)
- Prior treatment for PDAC (i.e., prior resection, radiotherapy, or chemotherapy)
- Current immunosuppressive (e.g., systemic steroid therapy) or chemotherapy
- Major surgery or significant trauma within 12 weeks prior to blood sample collection
- Non-PDAC malignancies within 3 years prior to sample collection squamous or basal cell skin carcinoma is not an exclusion criteria)
- Control patients who currently have
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PancreaSureSerum-based biomarker test comprised of ELISA-based analyte readings of 4 protein biomarkers (ICAM-1, TIMP1, THSB1, and CTSD) and CA19-9 summed by a mathematical algorithm with associated coefficients where a pre-defined cutoff establishes a positive or negative detection of PDAC. | Diagnostic test | High-Risk Controls, Pancreatic Ductal Adenocarcinoma (PDAC) Stage I and Stage II Cases |
Primary outcome
PancreaSure Sensitivity
Time frame: Baseline
Determine the sensitivity of PancreaSure in the classification of serum samples from patients diagnosed with PDAC as positive for PDAC, in a study sample containing both PDAC and control samples.
2 secondary outcomes
PancreaSure Specificity
Time frame: Baseline
Performance versus CA19-9 alone
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No. Individual patient test results will not be shared with patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricio Polanco, MD principal investigator
University of Texas Southwestern Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of the Pancreas and Pancreatic Cancer, run by Immunovia, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PancreaSure Sensitivity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.