Pancreatic Ductal Adenocarcinoma Clinical Trial
— CTC-AXL-PANCOfficial title:
Liquid Biopsy and Pancreas Cancer: Detection of AXL(+) Functional CTCs Using EPIDROP
In solid cancers, some more aggressive tumor cells actively detach from the primary lesion and then travel through the circulating compartment to reach distant organs and form micro-metastases. These circulating tumor cells (CTCs) that have become disseminated tumor cells (DTCs) flourish in their new environments and may remain dormant for many years after the complete resection of the primary tumor. Detecting CTCs in the blood is also relevant for assessing tumor progression, prognosis and therapeutic follow-up. The non-invasive, highly sensitive for CTCs analysis is called "liquid biopsy". Pancreatic adenocarcinoma and breast cancer remain among cancers of very poor prognosis and thus represent a major therapeutic challenge. In recent years, the Axl membrane tyrosine kinase receptor has been the target of growing interest. Activation of the Gas6/Axl signaling pathway is associated with, among other things, tumor cell growth and survival, epithelial to mesenchymal transition (EMT) or drug resistances. In addition, Axl overexpression is frequently identified in patients with pancreatic adenocarcinoma and is associated with a poor prognosis. For example, the Laboratoire des Cellules Circulantes Rares Humaines (LCCRH) at the CHU and the University of Montpellier has developed two new "CTC-AXL" tests to detect CTCs expressing Axl: one using the CellSearch® (gold standard and FDA-approved) system and the other using the EPIDROP technique. The purpose of this research project is to assess the concordance of the "CTC-AXL" measurement by the innovative EPIDROP technique and the CellSearch® technique in patients with metastatic pancreatic or breast cancer.
Status | Recruiting |
Enrollment | 63 |
Est. completion date | September 1, 2024 |
Est. primary completion date | June 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - The patient is at least 18 years old; - Patients with pancreatic cancer with remote metastases, naïve of any treatment, that is, eligible for a first line of treatment; - Patients with oral consent Exclusion Criteria: - Non-affiliation or non-beneficiary of a Social Security regimen; - Frailty persons according to Article L1121-6 of the CSP; - Adult protected or unable to give consent as per Article L1121-8 of the CPMP; - Pregnant or lactating women as per MSC L1121-5. - Not included for monitoring difficulties (mutation, insufficient motivation, predictable poor compliance, priority associated pathology in care, etc.) |
Country | Name | City | State |
---|---|---|---|
France | CHU Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CTC-AXL measurement concordance rate | CTC-AXL measurement concordance rate by EPIDROP (AXL(-): 0 vs AXL(+): 1) and CellSearch® (AXL(-): 0 vs AXL(+): 1) | 30 days | |
Secondary | Sensitivity (Se) defined as the proportion of AXL(+) positive patients (assessed by reference technique: CellSearch®) with a positive EPIDROP result | 30 days | ||
Secondary | Specificity (Sp) defined as the proportion of AXL(-) negative patients (assessed by reference technique: CellSearch®) with a negative result by EPIDROP | 30 days | ||
Secondary | Positive predictive value (PPV) defined as the proportion of patients with a positive EPIDROP result that is actually positive (as assessed by the reference technique: CellSearch®). | 30 days | ||
Secondary | Negative Predictive Value (VPN) defined as the proportion of patients, whose EPIDROP result is negative, that is effectively negative (assessed by reference technique: CellSearch®) | 30 days | ||
Secondary | Number of CTC-AXL at inclusion (0 vs 1 vs 2-3 vs 4 vs 5) measured by EPIDROP | 30 days | ||
Secondary | Number of CTC-AXL at inclusion (0 vs 1 vs 2-3 vs 4 vs 5) measured by the CellSearch technique® | 30 days | ||
Secondary | Overall Survival | Overall survival defined by the time between the date of diagnosis of the metastatic disease and the date of death regardless of the cause | 36 months | |
Secondary | Progression-Free Survival | Progression-free survival defined by the time between the date of diagnosis of the metastatic disease and the date of the 1st progression or the date of death regardless of the cause | 36 months | |
Secondary | Number of CTC at inclusion (0 vs 1 vs 2-3 vs 4 vs 5) measured by EPIDROP® | 30 days | ||
Secondary | Number of CTC at inclusion (0 vs 1 vs 2-3 vs 4 vs 5) measured by the CellSearch technique® | 30 days | ||
Secondary | CTC-PD-L1 measurement at inclusion (PD-L1(-): 0 vs PD-L1 (+): 1) measured by EPIDROP® | 30 days | ||
Secondary | CTC-PD-L1 measurement at inclusion (PD-L1(-): 0 vs PD-L1 (+): 1) measured by the CellSearch technique® | 30 days | ||
Secondary | Number of CTC-PD-L1 at inclusion (0 vs 1 vs 2-3 vs 4 vs 5) measured by EPIDROP® | Number of CTC labelled by anti-PD-L1 antibody detected by EPIDROP® | 30 days | |
Secondary | Number of CTC-PD-L1 at inclusion (0 vs 1 vs 2-3 vs 4 vs 5) measured by the CellSearch technique® | Number of CTC labelled by anti-PD-L1 antibody detected by CellSearch | 30 days | |
Secondary | Evaluation of circulating immune system: T cells | 30 days | ||
Secondary | Evaluation of circulating immune system: NK cells | 30 days | ||
Secondary | Evaluation of circulating immune system: B cells | 30 days | ||
Secondary | Evaluation of circulating immune system: macrophages | 30 days | ||
Secondary | Evaluation of circulating immune system: immune checkpoints | 30 days | ||
Secondary | Evaluation of circulating immune system: platelets | 30 days |
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