NCT06941987Not yet recruiting
Evaluate the Clinical Feasibility of a Novel Neoantigen-Reactive CD8+ T Cell (NART) Detection Technology for Postoperative MRD Surveillance of Pancreatic Cancer
Source: ClinicalTrials.gov · Last updated 24 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 66 (estimated)
- First submitted
- 12 Apr 2025
- Start date
- 20 Apr 2025
- Primary completion date
- 20 Oct 2025
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT06941987
What you commit to
- Study type: Observational
- Planned participants: 66
- From 20 Apr 2025 to the primary completion date, 20 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Lab values
- 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
Other
- Preoperative imaging examinations show distant metastasis
- Have participated in other interventional or observational clinical studies
Who the study is looking for
- 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
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan hospital, Shanghai Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.