Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens (ANoPs)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ARTIDIS AG
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Event-Free Survival (EFS)
研究概览
简要总结
The goal of this clinical study is to evaluate whether the NEO-Match® test, based on ARTIDIS nanomechanical profiling technology, can help predict treatment outcomes and improve clinical decision-making in patients with suspected pancreatic cancer undergoing biopsy.
The main questions this study aims to answer are:
- Can the NEO-Match® test predict how patients respond to neoadjuvant (pre-surgical) treatment for pancreatic cancer?
- How well does the NEO-Match® test detect malignant pancreatic lesions compared to standard histopathological assessment?
This is a prospective, single-arm study. Researchers will compare results from the NEO-Match® test with standard clinical outcomes, imaging findings, and pathology results to evaluate its predictive and diagnostic performance.
Participants will:
- Undergo a standard-of-care pancreatic biopsy or surgical procedure
- Provide an additional biopsy sample for research analysis using the ARTIDIS ART-1 device
- Continue to receive standard treatment and care, which is not influenced by the study
- Have clinical data, imaging results, and treatment outcomes collected
- Be followed every 3 months for up to 2 years
The study does not involve experimental treatment or changes to standard medical care. The information collected may help improve future diagnosis, prognosis, and treatment selection for patients with pancreatic cancer.
详细描述
Pancreatic ductal adenocarcinoma (PDAC) is associated with poor prognosis due to late diagnosis, early metastasis, and limited response to therapy. Current clinical, imaging, and molecular approaches have limitations in characterizing disease behavior and treatment response, particularly in the neoadjuvant setting. Additional methods to better understand disease characteristics in routine clinical practice are of interest.
This study evaluates the ARTIDIS nanomechanical profiling platform and its derived NEO-Match® score in pancreatic cancer. The ARTIDIS ART-1 system is an in vitro diagnostic device based on Atomic Force Microscopy (AFM) technology that measures the nanomechanical properties of fresh tissue samples. These measurements characterize structural and functional properties of tumor tissue and the surrounding microenvironment.
This is a prospective, single-arm clinical study enrolling adult patients (≥18 years) referred for biopsy of a suspected malignant pancreatic lesion. The study is conducted at Moffitt Cancer Center and is integrated into the standard clinical workflow. Participation does not alter, delay, or influence standard-of-care diagnostic or therapeutic procedures.
During routine biopsy or surgical resection, one additional research-use tissue sample may be collected when feasible. This sample will be analyzed using the ART-1 device prior to standard histopathological assessment. Following measurement, the tissue will be returned to the clinical workflow for routine pathology evaluation. Additional tissue samples may be collected during follow-up biopsies or surgery, when available.
The study will assess the relationship between nanomechanical measurements obtained using the ARTIDIS system and clinical data, including imaging findings, histopathology, treatment information, and patient outcomes. The primary objective is to evaluate the association between the NEO-Match® score and outcomes of neoadjuvant therapy, including event-free survival and pathological response. Secondary objectives include evaluation of associations with progression-free survival, overall survival, radiological response, and surgical outcomes, as well as assessment of agreement with standard histopathological classification of pancreatic lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Ability to understand and willingness to sign a written informed consent form
- •Clinical indication for fine needle biopsy (FNB) of a suspicious pancreatic lesion accessible for biopsy
排除标准
- •Any condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study
研究组 & 干预措施
Pancreatic Cancer Cohort
Participants with suspected pancreatic cancer undergoing standard-of-care biopsy or surgery, with additional tissue measurement using the ARTIDIS ART-1 device and prospective collection of clinical outcomes.
干预措施: ARTIDIS ART-1 Device (Device)
结局指标
主要结局
Event-Free Survival (EFS)
时间窗: Every 3 months, up to 24 months
Event-Free Survival (EFS) is defined as the time from initiation of anticancer therapy or study enrollment to the occurrence of an event, including disease progression, discontinuation of treatment for any reason, or death from any cause.
Pathological Response
时间窗: Up to 24 months (assessed following surgery or biopsy as applicable)
Pathological response is assessed based on surgical or biopsy specimens and categorized as complete response, partial response, or no response. The analysis evaluates the association between study measurements and pathological response.
次要结局
- Progression-Free Survival (PFS)(Up to 24 months (assessed at 12, 18, and 24 months))
- Disease-Free Survival (DFS)(Up to 24 months (assessed at 12, 18, and 24 months))
- Overall Survival (OS)(Up to 24 months (assessed at 12, 18, and 24 months))
- Radiological Response(After neoadjuvant therapy and prior to surgery)
- Surgical Outcome (Resection Status(Post-surgery assessment)
- Agreement With Histopathological Classification(Approximately 30 days after pathology report availability)
- Correlation With Molecular Subtypes(Approximately 30 days after pathology report availability)