Pancreatic Cancer Stage ICLARITINCT06947382
Clinical Validation of Immunovia Next-Generation Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer
An observational study of Pancreatic Cancer Stage I and Pancreatic Cancer Stage II, run by Immunovia, Inc. at 15 sites in 4 countries.
Trial summary
This is a case-control study to clinically validate the performance of 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… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer Stage I, Pancreatic Cancer Stage II, Cancer Diagnosis
- How many people
- 1,066 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 2 Sep 2024to 6 Jan 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Samples will be retrospectively obtained under the Immunovia PanDetect, PanFam or PRECEDE study protocols, 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 with clinical symptoms/signs (e.g. abnormal imaging of the pancreas such as fullness, unexplained weight loss, etc) suggestive of PDAC who were found to NOT have PDAC based on clinical investigation (imaging evidence within 6 months of blood draw)
- Controls will be selected to have similar demographic features (age/gender) to PDAC patients, as possible.
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
15 sites in 4 countries.
15 sites in 4 countries
United States12 sites
St. John's Cancer Institute
Burbank, California, 91505
University of Chicago Medical Center
Chicago, Illinois, 60637
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
University of California San Diego
La Jolla, California, 92093
Regional One Health
Memphis, Tennessee, 38103
University of Miami
Miami, Florida, 33136
Mount Sinai Hospital
New York, New York, 10029-6574
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213-2582
Oregon Health Sciences University
Portland, Oregon, 97239
Virginia Commonwealth University
Richmond, Virginia, 23284
HonorHealth Clinical Research Institute
Scottsdale, Arizona, 85258
Stanford Gastroenterology and Hepatology
Stanford, California, 94305
Canada1 site
The Research Institute of the McGill University Health Centre
Montreal
About this study
Official title: Multicenter, Case-Control Clinical Validation Study of a Multiplex Blood Protein Biomarker Test, IMMNOV-2, for Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in High-Risk Patients
This is a case-control study to clinically validate the performance of 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 case-control study is being conducted to determine the performance of a multiplex protein biomarker model in human serum samples.
Serum samples were collected for analysis from patients with Stages I and II pancreatic ductal adenocarcinoma (PDAC) and non-PDAC controls of similar demographics who were at increased risk of PDAC because their familial or genetic history or clinical symptoms. 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 three predefined (locked) algorithm with predefined (locked) cut-offs resulting in a positive/negative test outcome.
- Conditions
- Pancreatic Cancer Stage I, Pancreatic Cancer Stage II, Cancer Diagnosis, PDAC - Pancreatic Ductal Adenocarcinoma
- Keywords
- PDAC, pancreatic cancer, early detection, Pancreatic Cancer Stage I, Pancreatic Cancer Stage II, pancreatic cancer diagnosis, pancreatic ductal adenocarcinoma, pancreatic cancer detection
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PDAC Cases | Serum samples from patients recently diagnosed with Stage I or Stage II pancreatic adenocarcinoma (PDAC) with no prior treatment for disease | |
| Control | Serum samples from non-pancreatic adenocarcinoma (PDAC) patients at high-risk for disease due to familial or genetic history or clinical symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the sensitivity and specificity of IMMNOV-2 to differentiate serum samples from patients diagnosed with PDAC and controls.
Measured: Baseline
Secondary outcomes (3)
Sensitivity and specificity of IMMNOV-2 compared to sensitivity and specificity of CA19-9 alone in the overall population
Measured: Baseline
Sensitivity and specificity of IMMNOV-2 in patients age > or equal to 65 years of age
Measured: Baseline
Sensitivity and specificity of IMMNOV-2 compared to sensitivity and specificity of CA19-9 alone in patients age > or equal to 65 years old
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 start2 Sep 2024
- Primary completion9 Dec 2024
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer Stage IStudies 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
- 1,066 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunovia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947382
- Sponsor's protocol ID
- CLARITI-10
- Acronym
- CLARITI
- 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 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
- Multicenter, Case-Control Clinical Validation Study of a Multiplex Blood Protein Biomarker Test, IMMNOV-2, for Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in High-Risk Patients
- ClinicalTrials.gov ID
- NCT06947382
- Acronym / sponsor ID
- CLARITI / CLARITI-10
- Conditions
- Pancreatic Cancer Stage I, Pancreatic Cancer Stage II, Cancer Diagnosis, PDAC - Pancreatic Ductal Adenocarcinoma
- Keywords
- PDAC, pancreatic cancer, early detection, Pancreatic Cancer Stage I, Pancreatic Cancer Stage II, pancreatic cancer diagnosis, pancreatic ductal adenocarcinoma, pancreatic cancer detection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,066 participants (actual)
- Lead sponsor
- Immunovia, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 6 Jan 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 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 case-control study is being conducted to determine the performance of a multiplex protein biomarker model in human serum samples.
Serum samples were collected for analysis from patients with Stages I and II pancreatic ductal adenocarcinoma (PDAC) and non-PDAC controls of similar demographics who were at increased risk of PDAC because their familial or genetic history or clinical symptoms. 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 three predefined (locked) algorithm with predefined (locked) cut-offs resulting in a positive/negative test outcome.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDAC Cases | – | –Serum samples from patients recently diagnosed with Stage I or Stage II pancreatic adenocarcinoma (PDAC) with no prior treatment for disease |
| Control | – | –Serum samples from non-pancreatic adenocarcinoma (PDAC) patients at high-risk for disease due to familial or genetic history or clinical symptoms. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Samples will be retrospectively obtained under the Immunovia PanDetect, PanFam or PRECEDE study protocols, 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.
Primary outcome
Determine the sensitivity and specificity of IMMNOV-2 to differentiate serum samples from patients diagnosed with PDAC and controls.
Time frame: Baseline
3 secondary outcomes
Sensitivity and specificity of IMMNOV-2 compared to sensitivity and specificity of CA19-9 alone in the overall population
Time frame: Baseline
Sensitivity and specificity of IMMNOV-2 in patients age > or equal to 65 years of age
Time frame: Baseline
Sensitivity and specificity of IMMNOV-2 compared to sensitivity and specificity of CA19-9 alone in patients age > or equal to 65 years old
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 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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer Stage I and Pancreatic Cancer Stage II, run by Immunovia, Inc. at 15 sites in 4 countries.
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 15 sites in United States, Canada, Italy, Norway. 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?
Determine the sensitivity and specificity of IMMNOV-2 to differentiate serum samples from patients diagnosed with PDAC and controls. (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.