Liquid Biopsy and Pancreas Cancer: Detection of AXL(+) CTCs (CTC-AXL-PANC)

NCT05346536 | Recruiting DMC

• 1 other identifier: RECHMPL22_0024
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Cancer; Circulating Tumor Cell

Keywords

Metastatic Pancreatic Cancer; Circulating Tumor Cell; AXL; CellSearch

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Sensitivity (Se) defined as the proportion of AXL(+) positive patients (assessed by reference technique: CellSearch®) with a positive EPIDROP result

  30 days

• Specificity (Sp) defined as the proportion of AXL(-) negative patients (assessed by reference technique: CellSearch®) with a negative result by EPIDROP

  30 days

• 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

• 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

• Number of CTC-AXL at inclusion (0 vs 1 vs 2-3 vs 4 vs 5) measured by EPIDROP

  30 days

Study Arms (1)

Metastatic pancreatic cancer treatment-naive patients

EXPERIMENTAL

Newly diagnosed major patients with metastatic pancreatic cancer, naïve of any treatment for metastatic disease

Other: Detection of circulating tumor cells expressing Axl: CTC-AXL(+)

Interventions

Detection of circulating tumor cells expressing Axl: CTC-AXL(+) OTHER

Detection of CTC-AXL(+) using 2 techniques: * CellSearch®, FDA-USA approved technology * EPIDROP System CellSearch® (Menarini Company) The current gold-standard CellSearch® technique requires the use of CellSave tubes. This technique allows the isolation of fixed CTCs. This technique uses a positive (CellSearch® Epithelial Cell Kit) enrichment method from total blood using magnetic beads coupled to an EpCAM capture antibody. CTCs are then detected (anti-panCK antibodies, DAPI, anti-CD45 and characterized (anti-AXL antibody) by immunofluorescence (IF). EPIDROP It requires the use of EDTA tubes. This technique is based on a method of negative enrichment of CTCs from total blood using a cocktail of tetrameric antibodies to eliminate unwanted blood cells and to preserve only purified tumor cells (RosetteSep - StemCell Technology).Then, cells are loaded in a microfluidic chip. The detection and characterization is done by IF to the single cell in micro-droplets.

Metastatic pancreatic cancer treatment-naive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, 34090, France

RECRUITING

Related Publications (27)

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MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine Alix-Panabières, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Bardol, MD

CONTACT

+33682882757; t-bardol@chu-montpellier.fr

Sarah Girot

CONTACT

sarah.girot@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre prospective cohort Cohort of newly diagnosed major patients with metastatic pancreatic cancer, naïve of any treatment

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 26, 2022
• Study Start: June 16, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)