Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Immunomodulating Agents

Molecular monitoring by quantification of cell-free DNA (absolute value and variation from baseline) of two house-keeping genes (RPP30, TMEM11) by droplet digital PCR, during based-immunotherapy treatments of NSCLC patients.

Cell-free DNA will be extracted from 4 ml of plasma before treatments by immunotherapy, obtained from blood Streck® tubes.

Quantification of house-keeping genes (or mutated genes if some are previously routinely identified in tumor tissue) by ddPCR.

Molecular monitoring by quantification of cell-free DNA

BEAU-FALLER Michele, MD

WESTEEL Virginie, MD

Virginie WESTEEL, MD

Julie MORACCHINI, MD

Marie GAINET-BRUN, MD

Pascale JACOULET, MD

Olivier ADOTEVI, MD

Guillaume EBERST, MD

Emeline ORILLARD, MD

Hamadi ALMOTLAK, MD

MOREAU Lionel, MD

Lionel MOREAU, MD

Anne Catherine NEIDHARDT, MD

Jean-Philippe OSTER, MD

FOUCHER Pascal, MD

Pascal FOUCHER, MD

Astrid MERCIER, MD

Chems Eddine NESSAIBIA, MD

Fleur-Marie QUILOT, MD

Ayoub ZOUAK, MD

KADERBHAI Courèche, MD

DEBIEUVRE Didier, MD

Didier DEBIEUVRE, MD

Mathieu FORE, MD

Anthony GSCHWEND, MD

Emilie FOCH, MD

DEWOLF Maxime, MD

Maxime DEWOLF, MD

Gaëtan DESLEE, MD

Julien ANCEL, MD

Antoine DUMAZET, MD

MASCAUX Céline, MD

PAMART Guillaume, MD

MATAU César, MD

PABST Lucile, MD

MENNECIER Bertrand, MD PhD

COSSART Adrien, MD

STENGER Rodolphe, MD

MASCAUX Céline, MD PhD

CLEMENT-DUCHENE Christelle, MD

Christelle CLEMENT-DUCHENE, MD

Lionel UWER, MD

Non-small cell lung cancer (NSCLC) is a major public health problem. New treatments as immunotherapy can improve prognosis of patients with NCLC tumors. Nevertheless, no robust biomarker is actually available.

The hypothesis of the trial is to realize a longitudinal molecular monitoring of NSCLC patients treated by immunotherapy using a quantitative analysis of cell-free DNA.

The primary purposes is to study the predictive value of quantification of cell-free DNA at the first reevaluation time, on the clinical benefit, in NSCLC patients treated by immunotherapy (regardless of line, or associated treatments) The secondary purposes in this population of patients is to study the earlier predictive value (before the second treatment by immunotherapy ) of quantification of cell-free DNA, and its relationship with refractory disease and pseudo-progressive disease.

Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.

The quantification of cell-free DNA is realized by droplet digital PCR (ddPCR) using two house-keeping genes (RPP30, TMEM11); if a somatic mutation is identified in the paired tumor DNA in routine practice, this mutation is also quantify in the cell-free DNA from plasma. The quantification of cell-free DNA corresponds to the variation from the time at inclusion and the time at the first radiological evaluation.

The clinical benefit is defined by the duration of treatment by immunotherapy.

The quantification of cell-free DNA is realized by droplet digital PCR (ddPCR) using two house-keeping genes (RPP30, TMEM11); if a somatic mutation is identified in the paired tumor DNA in routine practice, this mutation is also quantify in the cell-free DNA from plasma.

The earlier quantification of cell-free DNA corresponds to the variation from the time at inclusion and the time before the second administration of immunotherapy.

University Hospital, Strasbourg, France

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Recurrence

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Determination of mutation of XPO1571K in patient with classical hodgkin Lymphoma by digital PCR on blood samples and biopsy

Determination of mutation of XPO1 E571K by digital PCR in blod sample of patient with classical hodgkin lymphoma

Digital Polymerase Chain Reaction

Fabrice JARDIN, PUPH

Doriane RICHARD, PhD

The purpose of this study is to determine if the XPO1 E571K mutation could be used as molecular residual disease biomarker in classical Hodgkin's lymphoma. To determine the interest of the mutation assessment by digital Polymerase Chain Reaction, sensitivity and specificity after 2 courses of chemotherapy (C2) will be compared with the deltaSUVmax determined by Positron Emission Tomography after C2 and at end of treatment.

A research team of Centre Henri Becquerel recently detected an unexpected recurrent point mutation of XPO1 (exportin 1) (also known as Chromosome Region Maintenance 1) located in exon 15 (c.1711G\>A) leading to the Glu571Lys (p.E571K) missense substitution in relapsed/refractory (R/R) Primary Mediastinal Large B-cell Lymphoma (PMBL) patients included in the LYSA LNH03 trial program and in classical Hodgkin's Lymphoma patients. It was found recurrent XPO1 E571K mutations in a large cohort of 94 patients with classical Hodgkin's lymphoma. This observation is new and could add new information on driver events and tumorigenesis in this disease. In total, 24.2 % of the patients with classical Hodgkin's lymphoma harbored the XPO1 E571K mutation. It is remarkable that 29% of all XPO1 mutations were only found in the plasma but not in the tumor because of the well-known tumor cell sparsity in Hodgkin's lymphoma. In this particular disease, highly sensitive techniques like digital Polymerase Chain Reaction and targeted Next-Generation Sequencing are essential to highlight low frequency mutations. The research team of the Centre Henri Becquerel have identified a trend toward unfavorable prognostic impact in terms of progression-free survival in patients with detectable XPO1 E571K mutation in plasma cell-free DNA at the end of treatment, which could prove to be statistically significant in a larger cohort. It was observed that 57% of patients who ultimately relapsed were positive in the plasma after end of therapy. It remains to be established whether this mutation adds new relevant value as compared to Positron Emission Tomography-scan.

Detection and Prognostic Value of Recurrent XPO1 Mutations of Patients With Classical Hodgkin Lymphoma

Prevalence, Kinetic and Prognostic Value of XPO1 E571K Mutation Detection in Plasma Cell-free DNA From Patients Xith Classical Hodgkin Lymphoma

Comparison of the sensitivity and specificity of the detection of the mutation between delta Standard Uptake Value max (SUV max) determined by PET after two courses of chemotherapy

difference between the variant allele fraction at the end of treatment and at the diagnosis

Difference of metabolic parameter in TEP between the end of treatment and the diagnosis

Time between the inclusion and the date of progression or death

Centre Henri Becquerel

Infections

Behaviors and Mental Disorders

Mycoses

Mycosis Fungoides

Lymphoma, T-Cell, Cutaneous

Lymphoma, Large B-Cell, Diffuse

Aggression

Lymphoma, T-Cell

Communicable Diseases

Bacterial Infections

Bacterial Infections and Mycoses

Lymphoma, Non-Hodgkin

Lymphoma, B-Cell

Cutaneous T-cell Lymphoma

B-cell Lymphoma

* Mycosis fungoides ≥ T2b
* Primary cutaneous T helper follicular lymphoma ≥ T2
* Primary cutaneous diffuse large B-cell lymphoma, leg type Genetic: Cytogenetic and molecular studies Detect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome.

Detect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome.

Cytogenetic and molecular studies

Anne PHAM-LEDARD, MD

To evaluate the possibility of detecting cell-free circulating tumoral DNA in potentially aggressive primary cutaneous lymphomas, the investigator opted to search a representative tumor sample mutation in the blood of these patients, by digital PCR. Patients with mycosis fungoides, primary cutaneous T-cell lymphoma helper follicular phenotype and primary cutaneous diffuse large B-cell lymphoma, leg-type will be included and 4 blood samples will be collected during 12 months.

Primary cutaneous lymphomas represent the second extra nodal localization of lymphomas, and are constituted by T-cell and B-cell phenotype lymphomas. Mycosis fungoides, a T-cell epidermotropic lymphoma, is the most frequent. Its clinical behavior is usually indolent but some patients have an aggressive evolution. Among B-cell cutaneous lymphomas, primary cutaneous diffuse large B-cell lymphoma, leg type (PCDLBCL-LT) is the most aggressive. Cytogenetic and molecular studies on these tumours led to a genetic characterization of these entities. Therefore, there is not any biologic marker that can help monitoring these lymphomas. In solid tumors, mutations exhibited by the tumour tissue has been detected in plasma of patients, assessing the possibility to detect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome. The concept of liquid biopsies, allowing the detection of tumour mutation in plasma has been validated in nodal diffuse large B-cell lymphoma. That's why the purpose is to evaluate the possibility to detect cell-free circulating tumoral DNA in primary cutaneous lymphomas, using a highly sensitive method (digital PCR), combined with a next generation sequencing panel of the tumour sample.

a collection of plasma collected at different times during the management of patients with aggressive cutaneous lymphomas followed at the University Hospital of Bordeaux.

Collection of tumor tissue biopsies for Next Generation Sequencing analysis

Cell-free Circulating DNA in Primary Cutaneous Lymphomas

Detection of Somatic Mutations on Cell-free Circulating DNA in Potentially Aggressive Cutaneous Lymphomas

University Hospital, Bordeaux

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.	NCT04720339	NSCLC IMMUNOTHERAPY QUANTIFICATION ...	Molecular monit...	18 Years -	University Hospital, Strasbourg, France
Detection and Prognostic Value of Recurrent XPO1 Mutations of Patients With Classical Hodgkin Lymphoma	NCT02815137	Classical Hodgk...	Digital Polymer...	18 Years -	Centre Henri Becquerel
Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.	NCT04720339	NSCLC IMMUNOTHERAPY QUANTIFICATION ...	Molecular monit...	18 Years -	University Hospital, Strasbourg, France
Cell-free Circulating DNA in Primary Cutaneous Lymphomas	NCT02883517	Mycosis Fungoid... Lymphoma, Large...	Cytogenetic and...	18 Years -	University Hospital, Bordeaux
Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.	NCT04720339	NSCLC IMMUNOTHERAPY QUANTIFICATION ...	Molecular monit...	18 Years -	University Hospital, Strasbourg, France

Spots Global Cancer Trial Database for digital pcr

Every month we try and update this database with for digital pcr 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 digital pcr

Every month we try and update this database with for digital pcr 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 digital pcr 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.