Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Neoplastic Cells, Circulating

Breast Diseases

Skin Diseases

Patients with documented (histologically/pathologically confirmed) mBC diagnosis, at lease 65 years of age at documented mBC diagnosis, and actively treated by a physician at a participating cancer center who routinely (i.e., test at lease every quarter) use CTC testing (excluding patients who sought consults or second opinions).

Alberto Montero, MD

The objective of the registry study is to demonstrate the clinical utility of the CELLSEARCH® CTC Test among the Medicare-Eligible metastatic Breast Cancer (mBC) patients in the United States. The objective of the present registry is to demonstrate the impact on patient management of the CELLSEARCH® CTC Test among the Medicare-eligible mBC patients. Hereto the hypothesis that the availability of CTC information provides clinicians important, timely information and impacts treatment decisions, will be tested.

This study is IDE-exempt since CELLSEARCH® CTC Test is a legally marketed device in the US, and is being used in accordance with its labeling.

Clinical Utility of CTC Test in Medicare-Eligible Metastatic Breast Cancer Patients

Registry to Demonstrate the Clinical Utility of CELLSEARCH® Circulating Tumor Cell (CTC) Test in Medicare-Eligible Metastatic Breast Cancer Patients

Percentage of treatment decisions that are indicated to be changed by the availability CTC results, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results).

The percentage of treatment decisions for which CTC results are indicated to add value to treatment decision making, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)

The relative value of CTC testing in treatment decisions as compared to other parameters, stratified by relevant criteria (e.g. patient and tumor characteristics, concordance and discordance with other test results)

Overall survival, calculated as the median (+/- standard deviation \[SD\]) length of time from initial diagnosis to death.

The Cleveland Clinic

Janssen Diagnostics, LLC

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neoplasm Metastasis

Neoplastic Processes

Neuroendocrine Tumor

Neuroepithelioma

Dermatologic Agents

All Drugs and Chemicals

Patients that have been hospitalized at the Nîmes University Hospital and who do not have dermatological cancer.

This cohort includes patients with metastatic melanoma.

Laurent Meunier, MD

The main objective of this study is to compare results for the detection of circulating melanoma cells (CMC) using CellSearch versus EPISPOT (EPithelial ImmunoSPOT) techniques between a group of patients with metastatic melanoma and a group of hospitalized control patients.

The secondary objectives of this study include:

A. To compare the following elements between the two patient groups:

* the number of CMCs per ml of blood as determined by EPISPOT
* the number of CMCs per ml of blood as determined by CellSearch
* the percentage of patients with at least 2 CMCs per ml of blood according to the two techniques
* the % of CMCs expressing KI67
* the % of CMCs expressions S100 (only the EPISPOT technique)

B. To compare the EPISPOT and CellSearch techniques is terms of the following:

* the number of CMCs detected per ml blood
* the number of CMCs expressing antigen KI67

C. To re-evaluate the 2-CMC per ml blood threshold

Circulating Tumor Cells and Melanoma: Comparing the EPISPOT and CellSearch Techniques

Circulating Tumor Cells and Melanoma: Comparing the EPISPOT (EPithelial ImmunoSPOT) and CellSearch Techniques

Presence/absence of at least 2 CMCs per ml blood, using both the Epispot and the CellSearch techniques

The number of CMCs per ml blood as determined by the Epispot technique

The number of CMCs per ml blood as determined by the CellSearch technique

The difference between the number of CMCs per ml blood detected with the CellSearch technique and the Epispot Technique (CellSearch - Epispot)

The % difference between the number of CMCs per ml blood detected with the CellSearch technique and the Epispot Technique (CellSearch - Epispot)/CellSearch\*100

Centre Hospitalier Universitaire de Nīmes

Digestive System Diseases

Gland and Hormone Related Diseases

Adenocarcinoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

Antibodies

Immunoglobulins

Pancrelipase

Pancreatin

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

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.

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

Thomas Bardol, MD

Sarah Girot

Catherine Alix-Panabières, PhD

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.

In solid cancers, after the formation and growth of the primary tumor, some more aggressive tumor cells actively detach from it and then travel through the circulating compartment to reach distant organs (bone marrow - liver - lung - brain...) and constitute new foci or 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. Due to events not fully elucidated, DTCs can develop on site giving rise to macroscopic metastases but also join again the circulating compartment in the form of CTCs, swarm, colonize other organs and cause secondary metastases.

Detecting CTCs in the blood is very relevant for assessing tumor progression but also promising in terms of cancer disease prognosis and therapeutic follow-up. This new approach, published for the first time in 2010 under the term liquid biopsy, is therefore defined as a non-invasive blood test, extremely sensitive, achievable in real time and that allows the analysis of CTCs.

Currently, the choice of targeted therapies for a given patient is made after analyzing the primary tumor for expression and/or genomic status of specific molecular targets.

Many studies show that metastatic cells have phenotypic and genotypic characteristics distinct from those of most of the primary tumor. This can be explained either because metastatic cells acquire new genomic skills over time, or because a subset of metastatic sub-clone pre-exists within the primary tumor but has escaped detection by standard tissue biopsy techniques.

A direct analysis of CTCs could provide important additional information to prevent patients from inappropriate, costly treatments and harmful side effects.

For several years, the AXL protein, a tyrosine kinase receptor, has emerged as a new strategic target in oncology. Over-expression of AXL has been frequently identified in patients with pancreatic adenocarcinoma. AXL is a member of the Tyro3-Axl-Mer family, like its ligand protein Gas-6 (growth arrest-specific). An activation of the Gas6/AXL signaling pathway results in the activation of several effector pathways such as RAS/RAF/MEK/ERK or PI3K/AKT and is associated with, among other things, tumor cell growth and survival, metastatic formation and dissemination, Epithelial-to-mesenchymal transition (EMT) or drug resistances. It has been shown clinically that the AXL protein is a factor of poor prognosis and resistance to reference treatments (radiotherapy, chemotherapy or targeted therapy). Thus, many therapeutic strategies have been proposed and developed to inhibit the AXL pathway, ranging from chemical molecules, blocking its kinase activity and therefore the underlying signaling pathways, to nucleotide aptamers, AXL fusion proteins, and monoclonal antibodies.

Pancreatic adenocarcinoma, the 4th leading of cancer related deaths, remains among cancers of very poor prognosis and thus represents a major therapeutic challenge. The median overall survival is 11.1 months after optimal treatment (FOLFIRINOX). The clinical relevance and oncogenic potential of AXL in the progression of different types of tumors have been largely evidenced. Indeed, 50% to 75% of pancreatic adenocarcinoma samples have overexpression of AXL and the level of expression of AXL is correlated with clinical parameters indicating tumor aggressiveness and poor prognosis such as frequency of distant metastases or the survival.

In this context, the LCCRH lab, which has specialized in the detection and analysis of CTCs for 20 years, has developed a CTC-AXL detection test using the CellSearch® system. The CellSearch® system is the only method approved by the Food and Drug Administration (FDA) for the detection of CTC in colorectal, breast and metastatic prostate cancers. In addition, the LCCRH holds a patent for another technology for the detection and characterization of live and functional CTCs, called EPIDROP. The implementation of the AXL research is already done for AXL labelling on CTCs in EPIDROP as well as the visualization of the AXL cleavage by live CTC.

Thanks to this unique functional test of CTCs, it is easy to imagine offering an oncology 'oncogram' by testing in real time the effectiveness of drugs on CTCs and personalized medicine to patients.

This real-time liquid biopsy proposal on functional CTCs is quite innovative in Oncology.

To date, there are no studies on the study of functional CTCs related to AXL.

Primary objective:

- Evaluate the concordance of the CTC-AXL measurement (inclusive) by the innovative EPIDROP technique and the CellSearch technique®

Secondary objectives:

* Evaluate the accuracy of the CTC-AXL measurement (inclusive) between EPIDROP and CellSearch®
* Assess the degree of agreement between CTC-AXL measurement (inclusive) by EPIDROP and CellSearch®
* Evaluate the overall survival of patients with metastatic pancreatic cancer based on the number of circulating tumour cells carrying the AXL marker measured by EPIDROP or CellSearch® at inclusion
* Evaluate the progression-free survival of patients with metastatic pancreatic cancer based on the number of circulating tumour cells carrying the AXL marker measured by EPIDROP or CellSearch® at inclusion
* Culture CTCs from the blood sample (EDTA 10mL)
* Creation of a single liquid biopsy bio-bank for pancreatic cancer involving only plasma storage

  * Study the expression of PD-L1 (at inclusion) and detect the CTC subgroup expressing PD-L1 using EPIDROP and CellSearch® techniques;
  * Study the circulating immune system in this cohort of patients with metastatic pancreatic cancer by performing immunological analysis on blood mononuclear cells;
  * Determine if there is a significant correlation between the detection of CTC and CTC-PD-L1 and the circulating immune system (T cells, NK cells, B cells, macrophages, immune checkpoints, platelets);
  * To assess the correlation between CTC, CTC-PD-L1 and immune cells and the clinical outcomes (progression-free survival, overall survival) of these patients with metastatic pancreatic cancer.

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

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

Liquid Biopsy and Pancreas Cancer: Detection of AXL(+) Functional CTCs Using EPIDROP

CTC-AXL measurement concordance rate by EPIDROP (AXL(-): 0 vs AXL(+): 1) and CellSearch® (AXL(-): 0 vs AXL(+): 1)

Overall survival defined by the time between the date of diagnosis of the metastatic disease and the date of death regardless of the cause

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

Number of CTC labelled by anti-PD-L1 antibody detected by EPIDROP®

Number of CTC labelled by anti-PD-L1 antibody detected by CellSearch

University Hospital, Montpellier

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Twenty ml of blood will be drawn from each patient : 10 ml of blood will be drawn on CellSave tubes (fixed cells) for CTC detection using the FDA-cleared CellSearch system (gold standard) and 10 ml of blood will be drawn on EDTA tubes (viable cells) for the detection of functional CTCs using the EPIDROP.

Blood sample

Catherine ALIX-PANABIERES, MCU-PH

Stephane DROUPY, MD

The use of liquid biopsy could be the key for precision medicine. Circulating tumor cells (CTCs) are the most studied circulating biomarkers used to assess the metastatic process and they have shown their clinical validity and utility in cancer patients. However, their detection and capture are still a challenge as they are very rare in the bloodstream. In this clinical trial named "EPIDROP", the investigators will use an innovative device called EPIDROP (for EPIspot in a DROP) in metastatic prostate cancer. EPIDROP is a completely new technology answering to biological and clinical questions by proposing a procedure detecting the functional subset of prostatic CTCs at the single cell level. The investigators will stain cells in the sample for EpCAM, PSMA, CD45 before to encapsulate them one by one in microdroplets and measure the PSA secretion by only the viable CTCs. This study aims to demonstrate the non-inferiority of the EPIDROP compared to the CellSearch system.

Methods :

One hundred patients with a metastatic prostate cancer will be recruited plus 50 healthy donors. Twenty ml of blood will be drawn : 10 ml of blood will be drawn on CellSave tubes (fixed cells) for CTC detection using the FDA-cleared CellSearch system (gold standard) and 10 ml of blood will be drawn on EDTA tubes (viable cells) for the detection of functional CTCs using the EPIDROP. Patients will be followed for 18 months.

Samples from fifty control subjects will be provided by the Etablissement Français du Sang.

Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer (EPIDROP)

Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer

Proportion of true positive and false negative patients with a confidence interval

Proportion of true negative and false positive healthy controls with a confidence interval

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

* at 4:00 a.m.
* at 10:00 a.m.

Patients will then be followed for data collection for a period of 12 months after inclusion or until disease progression (if applicable).

Blood samples will be collected at two times before the treatment initiation:

Carlos GOMEZ ROCA

Julien MAZIERES

This is a prospective pilot study designed to demonstrate the impact of circadian rhythm on the spread of Circulating Tumor Cells (CTCs) in patients with Non- Small Cell Lung Cancer - NSCLC.

27 patients will be included in the study and will be followed for 12 months.

For each included patient, blood samples will be collected before the anticancer treatment initiation.

Impact of Circadian Rhythm on the Spread of Circulating Tumor Cells in Lung Cancer Patients

Response will be assessed according to the clinician's judgment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Utility of CTC Test in Medicare-Eligible Metastatic Breast Cancer Patients	NCT02111031	Metastatic Brea... Breast Cancer		65 Years -	Janssen Diagnostics, LLC
Circulating Tumor Cells and Melanoma: Comparing the EPISPOT and CellSearch Techniques	NCT01558349	Metastatic Mela...		18 Years -	Centre Hospitalier Universitaire de Nīmes
Circulating Tumor Cells and Melanoma: Comparing the EPISPOT and CellSearch Techniques	NCT01558349	Metastatic Mela...		18 Years -	Centre Hospitalier Universitaire de Nīmes
Liquid Biopsy and Pancreas Cancer: Detection of AXL(+) CTCs (CTC-AXL-PANC)	NCT05346536	Pancreatic Duct... Metastatic Panc... Circulating Tum...	Detection of ci...	18 Years -	University Hospital, Montpellier
Liquid Biopsy and Pancreas Cancer: Detection of AXL(+) CTCs (CTC-AXL-PANC)	NCT05346536	Pancreatic Duct... Metastatic Panc... Circulating Tum...	Detection of ci...	18 Years -	University Hospital, Montpellier
Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer (EPIDROP)	NCT04581109	Prostate Cancer	Blood sample	18 Years -	University Hospital, Montpellier
Impact of Circadian Rhythm on the Spread of Circulating Tumor Cells in Lung Cancer Patients	NCT05988970	Lung Cancer	Blood samples w...	18 Years -	Institut Claudius Regaud

Spots Global Cancer Trial Database for cellsearch

Every month we try and update this database with for cellsearch cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cellsearch

Every month we try and update this database with for cellsearch cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cellsearch cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.