Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Patients over the age of 18 known for urological interventions for the following pathologies will be considered for enrollment in the group of cases:

- Bladder cancer

The exclusion criteria will be:

* Age under 18
* Pregnancy
* Lack of informed consent
* Inability to provide informed consent

Patients included in the study, who meet the inclusion criteria, have an operative note for:

* Transurethral Resection of Bladder Neoplasia (TURBT)
* Radical Cystectomy for Bladder Neoplasia

Biomolecular, proteomic, metabolomic and spectroscopy characterization of urothelial bladder neoplasia, on a 3D culture model (organoid) obtained from bladder tumor tissue

Biomarkers and proteomics

Simone Morselli, MD

Silvia Benemei, MD

Simone Morselli

Sergio Serni, Prof

Mauro Gacci, MD

Andrea Liaci, MD

Luca Gemma, MD

Our multicenter observational study is a non-profit prospective study. The study was born from the Amplitude Project, which comprise the SOD of Minimally Invasive Robotic Urological Surgery and Renal Transplants of AOU Careggi with the University of Florence, as well as with the National Research Council (CNR) and the University of Milan Bicocca (UNIMIB) The study consists of a phase of enrollment of patients who will be admitted to the SOD of Mini Invasive Robotic Urological Surgery and Renal Transplantation of AOU Careggi. Enrollment in the study does not alter normal clinical practice and does not involve additional risks for patients. Patients will have to meet the inclusion and exclusion criteria of the study and will be enrolled sequentially, until the established sample size is reached. Patients undergoing surgery for the removal of bladder neoplasm, be it endoscopic or surgical with radical intent (cystectomy), will be taken a fragment of tumor bladder tissue, on which histopathological analysis will be performed. In patients undergoing radical cystectomy only, a fragment of healthy urothelial tissue, free from neoplasia, will also be removed. The samples will be performed in patients under general and / or spinal anesthesia in case of TURB, thus not causing pain or discomfort to the patient, or ex-vivo on the operative piece in case of radical cystectomy, without causing further damage or pain to the patient. From these samples, specially stored in solutions that keep their characteristics unaltered, a 3D culture model (organoid) will be obtained both from cells obtained from bladder cancer and from healthy tissue on which biomolecular, metabolomic and spectroscopic characterization studies will be tested and carried out. with a view to staging and grading bladder neoplasia.

Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic

Definition of Tumor Bio-markers and Physical-spectroscopic Differences Between Healthy Urothelial Tissue Healthy and Urothelial Cancer

Metabolomic characteristic of bladder cancer

Spectroscopical characteristic of bladder cancer

Comparison between different progression pattern among bladder cancer

Comparison between different treatment response pattern among bladder cancer

Comparison between different survival outcomes among bladder cancer

Transcriptomic characteristic of bladder cancer

University of Milano Bicocca

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Careggi Hospital

University of Florence

PhD Student

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

40 patients in second and third line of treatment

Immune signature in serum associated to the metabolic signature

Meta-genomic signature of intestinal flora

Anne-Claire Toffart, Dr

Dalil Hannani, PhD

Immune checkpoints inhibitors (ICI) are becoming new standards of care for Non-Small Cell Lung Carcinoma (NSCLC) treatment. To date, no powerful predictive biomarker of response has been found.

The investigators hypothesize that metabolomics profile could represent a potent biomarker of response to ICI

Immune checkpoints inhibitors (ICI) are becoming new standards of care for Non-Small Cell Lung Carcinoma (NSCLC) treatment, both as first and second line of treatment. To date, no powerful predictive biomarker of response has been found. It has been recently shown that microbiota composition could dictate the ability of patients to respond to ICI. Since, the microbiota produces circulating metabolites that will subsequently act on immune system, the investigators hypothesized that metabolic signature, reflecting microbiota function, could represent a predictive biomarker of response to ICI.

Primary objective is to identify baseline metabolic signature (metabolomics analysis by Mass spectrometry) associated to ICI response. Secondary objectives are to link metabolic signature with microbiota composition (metagenomics analysis RNA 16S) and immune profile, and altogether with clinic response to ICI. Profile evolution (metabolic, metagenomics and immune) will be also analyzed at 2-month post ICI initiation and at tumor progression, if any.

In order to do so, the investigators thus plan to enroll 60 NSCLC patients treated by ICI as 1st, 2nd or 3rd line of treatment in CHUGA in 18 months. Blood as well feces will be collected prior to, and at 2 month following ICI treatment initiation as well as at progression. Will be excluded from this study, patients that have received antibiotic or corticotherapy 2 or 4 weeks before ICI initiation, respectively.

Identification of a Predictive Metabolic Signature of Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Carcinoma

: Identification of a Predictive Metabolic Signature of Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Carcinoma

To identify the link of the change from baseline of Metabolic signature in serum (metabolomics analysis performed using a Mass spectrometry) and the ICI response at 6 months or at the tumoral progression

To identify the link between the Meta-genomic signature of intestinal flora (microbiota composition analysed by RNA 16 S) with the Immune signature in serum and the metabolic signature at 6 months or at the tumoral progression

To identify the link between the Meta-genomic signature of intestinal flora with the Immune signature in serum and the ICI response at 6 months or at the tumoral progression

To describe the change from baseline of the Meta-genomic signature at 2 months or at the tumoral progression

To describe the change from baseline of the Immune signature at 2 months or at the tumoral progression

To identify the link between the profile change from baseline of meta-genomic signature and the ICI response at 2 months or at the tumoral progression

To identify the link between the profile change from baseline of immune signature and the ICI response at 2 months or at the tumoral progression

To describe of the overall survival under ICI at 6 months or at the tumoral progression

To describe the survival without progression under ICI at 6 months or at the tumoral progression

University Hospital, Grenoble

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Christine LOVERA

The breast cancer is composed of multiple biological entities. Recent progress in molecular biology, DNA or RNA chip, permitted the global tumour genome or transcriptome study. Those technics, leads to an increased in the molecular biology knowledge and a better oncogenesis understanding. Breast cancer taxonomy was established following the tumor genetic profile. Moreover this classification is incomplete and didn't include the metabolic pathways other than hormonal or HER2 pathways.

The metabolomics is an expanding field of research exploring the metabolites in cells, tissues or biologics fluids. It allows assessing the variation activation of the different cellular metabolic pathways. In oncology, it could highlight the main metabolic disturbances, the interaction of tumor cells and to identify the metabolic pathways involved in oncogenesis using the tumor cells metabolites profiles.

Compared to genomic, the metabolomics integrated the impact of the cells environments on the cells biology. The cells environment plays, in fact, a key role in the oncogenesis and in the tumor cells phenotypes. The metabolomics, thus being a complementary approach of the genomic in order to assess a better knowledge of the impact of the extracellular environment on the tumor cell phenotype. In addition, the metabolomics analyses are fast and not expensive compatible with routine practice.

The main objective of this study is to highlight a metabolic alteration specific to certain tumors phenotypes in order to have better understanding of the biology of the numerous breast cancer entities and find some biomarkers which could be some possible therapeutic target. Using a high resolution mass spectrometer, the investigators will analyze 52 tumor samples from frozen breast surgical specimen preserved in the Centre Antoine lacassagne tumor bank. The tissue analysis could be associated with a serum sample analysis from the frozen serum bank of the Centre Antoine Lacassagne. With 30 patients who performed a 18 FDG-PET before the surgery, The investigators will analyzed the correlation between the tumoral activation of the glycolysis pathways, quantified with mass spectroscopy and the 18FDG uptake. Using the 17 frozen serums available, the investigators will perform a screening to identify some metabolites or metabolites profile which could be detected in the serum in order to develop a new liquid biopsy approach. This study is a retrospective study based on data and sample already available in the center and collected during the routine practice.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic	NCT04770974	Urothelial Carc... Bladder Cancer Urothelial Neop... Urothelial Carc... Urothelial Carc...	Biomarkers and ...	18 Years -	University of Florence
Identification of a Predictive Metabolic Signature of Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Carcinoma	NCT04189679	Non Small Cell ...	Immune signatur... Meta-genomic si...	18 Years - 100 Years	University Hospital, Grenoble
Study of Metabolites Markers in Adjuvant Breast Cancer	NCT03367208	Breast Neoplasm...		10 Years -	Centre Antoine Lacassagne
Identification of a Predictive Metabolic Signature of Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Carcinoma	NCT04189679	Non Small Cell ...	Immune signatur... Meta-genomic si...	18 Years - 100 Years	University Hospital, Grenoble

Spots Global Cancer Trial Database for metabolomic

Every month we try and update this database with for metabolomic cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for metabolomic

Every month we try and update this database with for metabolomic 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 metabolomic 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.