Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Disease Progression

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

biomarker study

Alex Mirnezami, MD PhD

Nadia Peppa, PhD

Molecular pathology of Colorectal Cancer: Investigating the role of novel molecular profiles, microRNA's and their targets in Colorectal Cancer progression

Single centre observational cohort study Prospectively recruited patients biomarker evaluation and identification of novel biomarkers

Molecular Pathology of Colorectal Cancer: Investigating the Role of Novel Molecular Profiles, microRNA's, and Their Targets in Colorectal Cancer Progression

Molecular Pathology of Colorectal Cancer: Investigating the Role of Novel Molecular Profiles, microRNA's, and Their Targets in Colorectal Cancer

University of Southampton

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Goserelin

Bicalutamide

Antineoplastic Agents, Hormonal

Androgens

Androgen Antagonists

Hormones

Hormone Antagonists

bicalutamide (Casodex), goserelin (Zoladex)

Teuvo L Tammela, Professor

To evaluate anti-androgen (bicalutamide) induced biological and molecular changes in prostate comparison to chemical castration induced (goserelin) ones

Casodex/Zoladex Biomarkers in Localised Prostate Cancer

A Randomised Pilot Study to Evaluate the Effect(s) of Casodex 150 mg and Zoladex 3.6 mg on Pathological and Genomic Tumour Markers in Subjects Undergoing Radical Prostatectomy for Localised Prostate Carcinoma

Tampere University

Urinary Bladder Neoplasms

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

120 patients from Carte d'Identité des Tumeurs (CIT), Henri Mondor and Foch hospitals.

510 cystectomy patients operated between 2005 and 2010 in Henri Mondor and Foch hospitals.

188 patients treated by cystectomy and adjuvant chemotherapy for locally advanced bladder cancer from a national multicentric study.

93 patients from the clinical trial GETUG 19 (UNICANCER)

Yves ALLORY, MD, PhD

François RADVANYI, PhD

Muscle invasive (MIBC) and/or metastatic bladder cancer is associated with poor prognosis and no target therapies for this pathology are currently validated. By 40 gene expression signature realized on frozen samples, we have previously identified an aggressive sub-class of MIBC, called basal. This sub-class (20% of MIBC) showed strong EGFR dependence in vitro and in vivo (Rebouissou et al. Science Translational Medicine 2014). This observation suggests a possible response to EGFR targeted therapy in patients of this subgroup. Our aim is to establish a standard diagnostic tool to differentiate the basal subtype of bladder cancer and evaluate the effect of anti-EGFR therapy, by analyzing previous clinical trial (GETUG19) and preclinical models, which compare the classical chemotherapy to anti-EGFR associated chemotherapy.

The aim of this study is:

1. To validate a diagnostic test for formalin-fixed paraffin-embedded (FFPE) samples by Nanostring technology, using the 40 genes signature as reference. First, we will compare frozen and FFPE tissues (n=120), to establish a transcriptional signature in FFPE samples. Secondly, to further characterize basal subtype of bladder cancer, we will study the mutational and gain/loss landscape and immunohistochemistry markers in a new series of tumors after classifying them by our gene signature (n=510). These characteristics will be included in a new signature by defining the optimal prediction discrimination AIC et Net Reclassification Index.
2. To assess the prognosis after cisplatine treatment in 510 patients treated by cystectomy with or without adjuvant chemotherapy (pT2/pT3/pT4, N0 or N+) and in another multicentric series of 188 patients treated by cystectomy and adjuvant chemotherapy (pT3/pT4 et/ou N+). Uni and multi variant analysis will be realized by adjusted Cox model, and the added value of basal subtype as compared to standard prognostic factors will be evaluated. The propensity score will be realized to assess the association of basal subtype and response to chemotherapy. The anti-EGFR response will be analyzed in the clinical trial GETUG19 which uses Panitumumab in patients with metastatic urothelial carcinomas (n=93)
3. To study the treatment response in preclinical models. We characterized previously preclinical murine models derived from xenografts of MIBC (n=14 and new xenografts will be added). We will study the effect of anti-EGFR alone or in combination with chemotherapy in basal and non basal subtypes of xenografts.

By this study we will be able to better characterize the basal subtype of bladder cancer and confirm its aggressive behaviour as compared to other subtypes of MIBC. These results will further help to establish new clinical trials which include anti-EGFR in patients of basal subtype.

Tumor tissue : frozen (n=120), FFPE (n=911)

Basal Like Bladder Cancer : Signature and Therapeutic

Identification and Treatments of Basal Like Bladder Cancer (Study on Human Tumor Samples and Animal Models)

Ministry of Health, France

National Cancer Institute, France

Institut National de la Santé Et de la Recherche Médicale, France

Paris 12 Val de Marne University

Institut Curie

Assistance Publique - Hôpitaux de Paris

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

This is a biomarker study analyzing tissue for baseline biomarkers and collecting tissue at progression for further analysis of biomarkers changes after treatment with CDK 4/6 inhibitors and endocrine therapy

This is an open-label, multicenter study in patients with metastatic breast cancer who are candidates for standard first line treatment with palbociclib or ribociclib plus endocrine therapy. To be eligible, patients must have received no prior chemotherapeutic or hormonal regimen for metastatic disease. However, patients may still be considered eligible if they have already started treatment with endocrine therapy (an aromatase inhibitor or fulvestrant) plus palbociclib or ribociclib for no longer than 4 weeks prior to study enrollment, as long as they meet all other eligibility criteria. Eligible patients must have had a diagnostic biopsy of the metastatic lesion no more than 4 months prior to study enrollment and with sufficient tissue to complete the proposed biomarker analysis. Patients who develop disease progression within the first 12 months of starting palbociclib or ribociclib plus endocrine therapy will be eligible for an optional additional tissue biopsy at time of disease progression to repeat the analysis at time of disease progression and obtain real-time (10-14-day turn-around) multi-omic data produced under College of American Pathologist (CAP)/Clinical Laboratory Improvement Amendments (CLIA) development and/or compliant practices.

Utilizing Multiomic Advanced Diagnostics to Identify CDK 4/6 Inhibitor Response Predictors and a Post-treatment Multiomic Signature for Patients With ER+/HER2- Metastatic Breast Cancer

The data from this exploratory analysis will help generate hypotheses for future studies.

Establish baseline values in tumor tissue to use as predictive markers

Identify CDK 4/6 kinase which are either direct substrates or controlled secondarily by CDK 4/6 activity.

Evaluate tissue collected at progression for changes in CDK 4/6 biomarkers after treatment with CDK 4/6 inhibitors.

Evaluate tissue collected at progression for activation state of signaling pathways that are known markers for endocrine resistance

Evaluate frequency with which multiomic profiling analysis of patient's tumor identifies a target that can be treated by an FDA-approved agent or regimen

Evaluate percentage of time when treatment recommendations found with multiomic profiling is different than treatment selected by a patient's physician

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular Pathology of Colorectal Cancer: Investigating the Role of Novel Molecular Profiles, microRNA's, and Their Targets in Colorectal Cancer Progression	NCT03309722	Colorectal Canc...	biomarker study	18 Years -	University of Southampton
Casodex/Zoladex Biomarkers in Localised Prostate Cancer	NCT00293696	Prostate Cancer	bicalutamide (C...	18 Years - 70 Years	Tampere University
Casodex/Zoladex Biomarkers in Localised Prostate Cancer	NCT00293696	Prostate Cancer	bicalutamide (C...	18 Years - 70 Years	Tampere University
Basal Like Bladder Cancer : Signature and Therapeutic	NCT02648100	Muscle Invasive... Molecular Taxon...	biomarker study	18 Years - 70 Years	Assistance Publique - Hôpitaux de Paris
Utilizing Multiomic Advanced Diagnostics to Identify CDK 4/6 Inhibitor Response Predictors and a Post-treatment Multiomic Signature for Patients With ER+/HER2- Metastatic Breast Cancer	NCT03195192	Metastatic Brea...	biomarker study	18 Years -	Side-Out Foundation
Utilizing Multiomic Advanced Diagnostics to Identify CDK 4/6 Inhibitor Response Predictors and a Post-treatment Multiomic Signature for Patients With ER+/HER2- Metastatic Breast Cancer	NCT03195192	Metastatic Brea...	biomarker study	18 Years -	Side-Out Foundation

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