Minimal Residual DiseaseNCT06941987
Evaluate the Clinical Feasibility of a Novel Neoantigen-Reactive CD8+ T Cell (NART) Detection Technology for Postoperative MRD Surveillance of Pancreatic Cancer
An observational study of Minimal Residual Disease and Pancreatic Cancer Resectable, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about the diagnostic performance of a novel Neoantigen-Reactive CD8+ T cell (NART) technology detecting minimal residual disease (MRD) in postoperative surveillance of pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimal Residual Disease, Pancreatic Cancer Resectable
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2025to 20 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receive radical resection without naoadjuvant therapy and diganosed pancreatic ductal adenocarcinoma pathologically are eligible.
Who may be able to join
- age >18
- Assessd as resectable PDAC before surgical procedure
- Voluntary to donate tumor samples resected in curative surgery for PDAC
- Voluntary to participate in the radiological evaluation, tests of serum tumor markers, and the collection of MRD samples according to the study protocol
- ECOG state (PS) grades ≤ 2
- Voluntary to sign informed consent and adhering to the requirements and limitations outlined by lCD and this protocol
Show all 10Show fewer
- Confimed as pancreatic ductal adenocarcinoma by pathology
- RO or R1 resection
- Clinically evalutated eligible for adjuvant therapy
- Tumor tissue samples meet the requirements of whole exome sequencing (WES)
Who cannot join
- Preoperative imaging examinations show distant metastasis
- Have received neoadjuvant therapy
- Have any other active malignancy within 5 years before enrollment, or have any other indolent cancers that did not interfere with the primary cancer assessment in the study without prior approval from the research committee
- With other physical or mental conditions that may increase the risk of study participation or (in the investigator's judgment) may make the subject ineligible for study participation, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormalities
- Have participated in other interventional or observational clinical studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital, Shanghai
Shanghai
Wen-Quan Wang, +86 21 31587861, wang.wenquan@zs-hospital.sh.cn
About this study
The goal of this observational study is to learn about the diagnostic performance of a novel Neoantigen-Reactive CD8+ T cell (NART) technology detecting minimal residual disease (MRD) in postoperative surveillance of pancreatic cancer. The main question it aims to answer is: Is NART a sensitive and accurate detection for MRD? Participants are required to undergo periodic blood sampling and imaging examinations as the protocol specifies.
- Medical subject headings
- Neoplasm, Residual
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between NART detection and recurrence-free survival
Measured: From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months
Secondary outcomes (8)
The correlation between conventional ct-DNA test and RFS
Measured: From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months
The correlation between serum markers and RFS
Measured: From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months
The correlation between NART detection and overall survival (OS)
Measured: From date of surgery until the date of death, assessed 3 months thereafter up to 60 months
The correlation between conventional ct-DNA test and OS
Measured: From date of surgery until the date of death, assessed 3 months thereafter up to 60 months
The correlation between serum markers and OS
Measured: From date of surgery until the date of death, assessed 3 months thereafter up to 60 months
The diagnostic performance of NART detection
Evaluation index of diagnostic performance include: sensitivity, specificity, positive predictive value, negative predictive value and lead time advantages over radiological recurrence manifestations. Sensitivity is defined as the proportion of subjects who tested positive for MRD/elevated serum tumor markers at or before recurrence confirmed by clinical imaging. Specificity was defined as the proportion of subjects who tested negative for MRD/normal serum tumor markers at or before clinical imaging confirmation of relapse. Positive Predictive Value (PPV) and Negative Predictive Value (NPV) are defined as the proportion of subjects testing MRD-positive/negative who are clinically confirmed to relapse/remain relapse-free, respectively. Lead time is defined as the time interval from MRD positivity or serum tumor marker elevation to imaging-confirmed clinical relapse.
Measured: From the date of first enrollment until the study completion, an average of 30 months.
The diagnostic performance of conventional ct-DNA test.
Evaluation index of diagnostic performance include: sensitivity, specificity, positive predictive value, negative predictive value and lead time advantages over radiological recurrence manifestations. Sensitivity is defined as the proportion of subjects who tested positive for MRD/elevated serum tumor markers at or before recurrence confirmed by clinical imaging. Specificity was defined as the proportion of subjects who tested negative for MRD/normal serum tumor markers at or before clinical imaging confirmation of relapse. Positive Predictive Value (PPV) and Negative Predictive Value (NPV) are defined as the proportion of subjects testing MRD-positive/negative who are clinically confirmed to relapse/remain relapse-free, respectively. Lead time is defined as the time interval from MRD positivity or serum tumor marker elevation to imaging-confirmed clinical relapse.
Measured: From the date of first enrollment until the study completion, an average of 30 months.
The diagnostic performance of serum markers.
Evaluation index of diagnostic performance include: sensitivity, specificity, positive predictive value, negative predictive value and lead time advantages over radiological recurrence manifestations. Sensitivity is defined as the proportion of subjects who tested positive for MRD/elevated serum tumor markers at or before recurrence confirmed by clinical imaging. Specificity was defined as the proportion of subjects who tested negative for MRD/normal serum tumor markers at or before clinical imaging confirmation of relapse. Positive Predictive Value (PPV) and Negative Predictive Value (NPV) are defined as the proportion of subjects testing MRD-positive/negative who are clinically confirmed to relapse/remain relapse-free, respectively. Lead time is defined as the time interval from MRD positivity or serum tumor marker elevation to imaging-confirmed clinical relapse.
Measured: From the date of first enrollment until the study completion, an average of 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start20 Apr 2025 (estimated)
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Residual DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941987
- Sponsor's protocol ID
- ZSPAC-11
- Status last verified
- Mar 2025
- First submitted
- 12 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Clinical Feasibility of a Novel Neoantigen-Reactive CD8+ T Cell (NART) Detection Technology for Postoperative MRD Surveillance of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06941987
- Acronym / sponsor ID
- ZSPAC-11
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Oct 2027 (estimated)
- First posted
- 24 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.
The goal of this observational study is to learn about the diagnostic performance of a novel Neoantigen-Reactive CD8+ T cell (NART) technology detecting minimal residual disease (MRD) in postoperative surveillance of pancreatic cancer. The main question it aims to answer is: Is NART a sensitive and accurate detection for MRD? Participants are required to undergo periodic blood sampling and imaging examinations as the protocol specifies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receive radical resection without naoadjuvant therapy and diganosed pancreatic ductal adenocarcinoma pathologically are eligible.
Key inclusion criteria (10 listed)
- age >18
- Assessd as resectable PDAC before surgical procedure
- Voluntary to donate tumor samples resected in curative surgery for PDAC
- Voluntary to participate in the radiological evaluation, tests of serum tumor markers, and the collection of MRD samples according to the study protocol
- ECOG state (PS) grades ≤ 2
Key exclusion criteria (5 listed)
- Preoperative imaging examinations show distant metastasis
- Have received neoadjuvant therapy
- Have any other active malignancy within 5 years before enrollment, or have any other indolent cancers that did not interfere with the primary cancer assessment in the study without prior approval from the research committee
- With other physical or mental conditions that may increase the risk of study participation or (in the investigator's judgment) may make the subject ineligible for study participation, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormalities
- Have participated in other interventional or observational clinical studies
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
The correlation between NART detection and recurrence-free survival
Time frame: From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months
8 secondary outcomes
The correlation between conventional ct-DNA test and RFS
Time frame: From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months
The correlation between serum markers and RFS
Time frame: From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months
The correlation between NART detection and overall survival (OS)
Time frame: From date of surgery until the date of death, assessed 3 months thereafter up to 60 months
The correlation between conventional ct-DNA test and OS
Time frame: From date of surgery until the date of death, assessed 3 months thereafter up to 60 months
The correlation between serum markers and OS
Time frame: From date of surgery until the date of death, assessed 3 months thereafter up to 60 months
The diagnostic performance of NART detection
Time frame: From the date of first enrollment until the study completion, an average of 30 months.
The diagnostic performance of conventional ct-DNA test.
Time frame: From the date of first enrollment until the study completion, an average of 30 months.
The diagnostic performance of serum markers.
Time frame: From the date of first enrollment until the study completion, an average of 30 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Minimal Residual Disease and Pancreatic Cancer Resectable, run by Shanghai Zhongshan Hospital at 1 site in China.
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 10 inclusion and 5 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: opening soon, as of the sponsor's last update on 24 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 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenquan Wang (+86 21 31587861, wang.wenquan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between NART detection and recurrence-free survival (time frame: From date of surgery until the date of diagnosis of local or metastatic recurrence, assessed 3 months thereafter up to 60 months). 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 24 Apr 2025.