Neoplasms

All Conditions

Rare Diseases

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Proteomic analysis of bile samples will be performed every 5 bile samples. Bile samples will be taken during endoscopy with retrograde papillary catheterization or radiological procedures in selected patients. In clinical practice, bile samples are taken for bacteriological purposes. An average of 10 mL is taken.

Five mL are required for bacteriological analysis. The remaining millilitres, which are usually discarded, will be kept for storage and to form the bile bank at the Biological Resources Centre before to be analyzed in proteomics.

Proteomic profile

Arthur Marichez, MD

The main aim of the study is to develop a diagnostic proteomic profile of cholangiocarcinoma using bile samples. The primary endpoint will be the rate of concordant positive diagnoses obtained from bile samples based on proteomic profiling compared with histological reference diagnoses (concomitant cytological sampling and/or final histological sampling).

Cholangiocarcinoma has a poor 5-year prognosis (less than 5%) and is rarely resectable at diagnosis. Diagnosis is made by histological sampling (biopsy or endo-biliary brushing) during endoscopic retrograde catheterization of the papilla or radiologically during transparietohepatic drainage. Conventional histology techniques have a low sensitivity of around 14-60%, which leads to diagnostic delays, repeated invasive examinations and delays in therapeutic management, sometimes with progression from a resectable to an unresectable stage.

New techniques are emerging to optimize the diagnosis of cholangiocarcinoma, in particular molecular techniques. This is the case with proteomics and proteomic profiling, which consists of obtaining diagnostic information from all the proteins contained in biological samples.

Furthermore, during diagnostic procedures for cholangiocarcinoma, bile samples are taken, initially for bacteriological purposes. Proteomics has been shown to be a tool capable of identifying potential diagnostic biomarkers in bile samples. To date, proteomic profiling has never been tested on bile samples for diagnostic purposes, although its proof of concept has been established.

Obtaining a proteomic profile for the diagnosis of cholangiocarcinoma from bile samples would enable the development of an innovative tool that has not yet been described in this field. It would optimize the management of patients with cholangiocarcinoma, with the possibility of a quicker diagnosis enabling optimal management as soon as the first clinical symptoms appear, while reducing the number of examinations required to obtain a diagnosis.

Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy

rate of positive diagnosis of cholangiocarcinoma obtained from bile samples using proteomic profile analysis compared with the rate of positive diagnosis using histological reference tools.

pecific analysis of proteomic data to identify a recurrent, malignancy-specific target protein

differential diagnosis rates obtained by proteomic profiling compared with histological results

rate of positive diagnoses with the Next-Generation Sequencing technique

University Hospital, Bordeaux

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Nervous System Diseases

Neoplasm Metastasis

Breast Neoplasms

Meningitis

Breast Diseases

Skin Diseases

Neuroinflammatory Diseases

Anticonvulsants

All Drugs and Chemicals

Consultation, Cerebral and medullary MRI, lumbar puncture, CSF sampling, blood sample, collection of breast fluid

History of the disease, anatomopathological and molecular biological data concerning the initial tumor; Collection of treatments received and/or in progress by the patient for her meningeal tumor (chemotherapy, targeted therapy, radiotherapy, surgery, corticosteroids, antiepileptics); Evaluation of the general condition and neurological status.

Consultation

Cerebral and medullary MRI, lumbar puncture, CSF sampling

5 ml of additional CSF after diagnostic lumbar puncture for proteomic analysis, 50-100 µl of breast aspiration fluid (NAF) for patients with an existing breast tumor, for proteomic analysis 10 ml of blood for proteomic analysis

biological test

Julien Thery

Claire CHEYMOL

Claire Cheymol, MD

The investigators are interested in one of the most frequent tumor types causing leptomeningeal metastasis in order to investigate whether a profile can be established by a high-throughput clinical proteomic approach. All the data acquired will allow a tailored and promising approach to improve the knowledge of metastatic tumor meningitis.

The primary objective is to describe on an exploratory basis the association between the type of proteomic profile from cerebrospinal fluid (CSF) microvesicles (from unsupervised bioinformatics analysis) and CSF cytology analysis (positive, negative, equivocal) in breast cancer patients with suspected leptomeningeal metastases, on initial CSF samples (hereafter referred to as initial proteomic profile and initial cytology).

Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis (Exo-LCR)

Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis From Breast Cancer

The CSF proteomic profile will be obtained by an unsupervised bioinformatics analysis of the CSF collected during the initial diagnostic workup for all patients and in case of renewal of the initial lumbar puncture if the 1st one was not exploitable for the CSF cytological analysis.

The bioinformatics analysis will allow to obtain the protein composition and to establish proteomic profile.

The cytological analysis of the CSF will allow to obtain 3 possible results: Positive / Negative / Equivocal at the time of the initial diagnostic workup for all patients and in case of renewal of the initial LP if the 1st one was not exploitable for the cytological analysis of the CSF, for all patients.

Centre Oscar Lambret

Meningeal Carcinomatosis

Neoplastic Processes

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Collection of cerebrospinal fluid and blood samples:

* At initial diagnostic assessment;
* 1 month and 3 months after initial diagnostic assessment, for patients classified "possible", "probable" or "confirmed" according to EANO-ESMO classification, leading to specific leptomeningeal metastase treatment;
* In case of symptoms leading to leptomeningeal metastase suspicion and at least 3 months after diagnostic assessment, for patients classified "lack of evidence" according to EANO-ESMO classification.

At the initial diagnostic assessment, 3mL of cerebrospinal fluid and 10 ml of blood sample will be collected in order to determine the proteomic profile. Cerebrospinal fluid will be collected during a lumbar puncture aiming to diagnose leptomeningeal metastases.

Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment

3mL of cerebrospinal fluid and 10 ml of blood sample will be collected:

* When suspected metastatic meningitis symptoms arise and
* at least 3 months after the initial diagnostic assessment, In order to determine the proteomic profile. Cerebrospinal fluid will be collected during a lumbar puncture aiming to diagnose leptomeningeal metastases.

Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "Lack of evidence" according to EANO-ESMO classification

3mL of cerebrospinal fluid and 10 ml of blood sample will be collected:

* 1 month after the beginning of the specific treatment,
* 3 months after the beginning of the specific treatment. Cerebrospinal fluid will be collected during a lumbar puncture aiming to assess treatment response or at intrathecal injection of treatment.

Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are "confirmed", "probable" or "possible", leading to leptomeningeal metastase specific treatment

Emilie LE RHUN, MD

This is a multicenter, interventional, prospective study among breast cancer patients with a suspicion of metastatic meningitis. The current study aims to assess the use of proteomic profile issued from cerebrospinal fluid microvesicles for diagnosis of leptomeningeal metastases.

The aim of this study is to describe the association between the initial proteomic profile issued from cerebrospinal fluid microvesicles and the initial cytological analysis of the cerebrospinal fluid in breast cancer patients with a suspicion of metastatic meningitis.

Other objectives of the study include:

* Describing the association between the initial proteomic profile and:

  * the histological types and hormonal receptors status of the breast cancer,
  * the likelihood of leptomeningeal metastasis according to the EANO-ESMO classification (Lack of evidence / possible / probable / confirmed) ,
  * the likelihood of leptomeningeal metastasis according to the EANO-ESMO classification, combined with histological type and hormonal receptors status.
* Evaluate the prognostic value of the proteomic profiling for overall survival, according to the EANO-ESMO classification and other known prognosis factors, in patients classified "possible", "probable" or "confirmed" leading to leptomeningeal metastases specific treatment,
* Evaluate the impact of the evolution of the proteomic profile a month after the start of this treatment on the overall survival, in patients with leptomeningeal metastases specific treatment,
* Evaluate the association between the proteomic profile and the EANO-ESMO classification at least 3 months after the initial EANO-ESMO classification,
* Evaluate the evolution of the proteomic profile 3 months after the initial EANO-ESMO classification, in patients initially classified "lack of evidence", broadly and according to the evolution of cytology, the administered treatments and to the EANO-ESMO response if applicable,
* Compare the proteomic profiles issued from cerebrospinal fluid and blood

Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.

Benefit of Analyzing Exosomes in the Cerebrospinal Fluid During the Medical Care of Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.

Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid.

Results of cytological analysis of cerebrospinal fluid will be "Positive", "negative", "equivocal".

Proteomic profile will be obtained by bioinformatic analysis of cerebrospinal fluid:

* 1 month and 3 month after the start of a specific treatment of the leptomeningeal metastasis, if applicable,
* 3 months after the initial diagnosis of leptomeningeal metastasis if the likehood of leptomeningeal metastasis is "lack of evidence".

Histological subtype will be subdivised as invasive ductal breast carcinoma, invasive lobular breast carcinoma, other brest carcinoma.

Hormonal receptors status will be subdivised as:

* Positive hormonal receptors / Positive HER2
* Positive hormonal receptors / Negative HER2
* Negative hormonal receptors / Positive HER2
* Triple negative

EANO-ESMO classification is obtained by searching clinical symptoms, cancer cells in the cerebrospinal fluid (obtained by lumbar puncture), signs in RMI. The likehood of leptomeningeal metastasis is:

* Lack of evidence,
* Possible,
* Probable,
* Confirmed.

Overall survival is defined as time from date of registration to date of death regardless of the cause.

Proteomic profile will be obtained by bioinformatic analysis of blood.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy	NCT06416397	Cholangiocarcin...	Proteomic profi...	18 Years -	University Hospital, Bordeaux
Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis (Exo-LCR)	NCT05286684	Breast Cancer	Consultation Cerebral and me... biological test	18 Years -	Centre Oscar Lambret
Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.	NCT03974204	Breast Cancer Leptomeningeal ...	Cerebrospinal f... Cerebrospinal f... Cerebrospinal f...	18 Years -	Centre Oscar Lambret
Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.	NCT03974204	Breast Cancer Leptomeningeal ...	Cerebrospinal f... Cerebrospinal f... Cerebrospinal f...	18 Years -	Centre Oscar Lambret
Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.	NCT03974204	Breast Cancer Leptomeningeal ...	Cerebrospinal f... Cerebrospinal f... Cerebrospinal f...	18 Years -	Centre Oscar Lambret
Analyses of Exosomes in the Cerebrospinal Fluid for Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.	NCT03974204	Breast Cancer Leptomeningeal ...	Cerebrospinal f... Cerebrospinal f... Cerebrospinal f...	18 Years -	Centre Oscar Lambret
Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy	NCT06416397	Cholangiocarcin...	Proteomic profi...	18 Years -	University Hospital, Bordeaux

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