Genetic: Establishment of the genetic and immunologic profile

Whole blood sampling :

* 1 tube for the constitutional DNA extraction;
* 3 tubes for ancillary studies and research.

Collection of the available archival tumor sample (frozen or FFPE). If there's no available sample, the investigator will prescribe a biopsy of a reachable lesion.

With the established profile, recommendations will be given by a multidisciplinary molecular board.

Blood and tumor samples

Jean-Yves BLAY, MD

Mélodie Carbonnaux, MD

Mathieu Baconnier, MD

Marie Louvel, MD

Emmanuel Maillard, MD

Aude Montchaud, MD

Oana Pop, MD

Laurence Renaud, MD

Sarah Sannicolo, MD

Laetitia Stefani, MD

Elsa Thimonier, MD

Marie Valee, MD

Cécile LEYRONNAS, MD

Julien FORESTIER, MD

Catherine LOMBARD BOHAS, MD

Thomas WALTER, MD

Thomas BACHELOT, MD

Amine BELHABRI, MD

Christophe BERGERON, MD

Pierre BIRON, MD

Helen BOYLE, MD

Philippe CASSIER, MD

Patrick COMBEMALE, MD

Françoise DESSEIGNE, MD

Cécile FAURE-CONTER, MD

Jérome FAYETTE, MD

Aude FLECHON, MD

Christelle DE LA FOUCHARDIERE, MD

Hervé GHESQUIERES, MD

Jean-Paul GUASTALLA, MD

Pierre GUIBERT, MD

Pierre-Etienne HEUDEL, MD

Sylvie NEGRIER, MD

Eve-Marie NEIDHARDT, MD

Emmanuelle NICOLAS-VIRELIZIER, MD

Maurice PEROL, MD

Isabelle RAY-COQUARD, MD

Paul REBATTU, MD

Catherine SEBBAN, MD

Olivier TREDAN, MD

Alice LEVARD, MD

Virginie AVRILLON, MD

Louis TASSY, MD

Pierre Fournel, MD

Claire Bosacki, MD

Aline Guillot, MD

Jean-Philippe Jacquin, MD

Thierry Muron, MD

Romain Rivoirard, MD

Léa Saban-Roche, MD

Cécile Vassal, MD

Jean-Yves BLAY, MD PhD

It is a non-randomized, multicentric, cohort study, combined with a biological sample collection, a clinical data collection and with a genetic and immunologic biomarkers study.

The ProfiLER program aims to implement a personalized cancer medicine approach by proposing to establish the genetic and immunologic profile of the tumor for patients with an advanced malignant tumor, in order to define a map of genetic (for the pre-identified target genes) and immunologic profiles for all the studied types of cancer. This study will also allow adapting the therapeutic management of these patients, if needed, by giving them targeted therapies or immunotherapies (commercialized on in ongoing clinical trials), based on the recommendations of the multidisciplinary molecular board.

The genetic and immunologic profile of the tumor will be determined from archival or fresh collected (biopsy of a reachable lesion) tumor sample and from a blood sample. The correlation between genetic profiles of the tumor, patients immunity status and clinical data (progression, tumor response, etc.) collected from the patient medical records will probably allow us to identify biomarkers with a potential predictive value and to determine if some genetic disorders are linked to immunity status alterations.

Determination of the tumor profile and review in multidisciplinary molecular board:

The genetic and immunologic profile will be performed from the available tumor sample and from a blood sample.

Genetic profile:

* Research of mutations/insertions/deletions for an array of predefined genes in tumor deoxyribonucleic acid by high-throughput sequencing
* Analysis of copy number variations of genes on tumor deoxyribonucleic acid by microarray-based comparative genomic hybridization
* Analysis of rearrangements involving the gene Anaplastic Lymphoma Kinase that can't be detected by Next Generation Sequencing or array Comparative Genomic Hybridization (balanced translocations) by means of fluorescent hybridization probes on tumor samples Immunologic profile: analysis of the expression of relevant immunologic markers

Clinical data collection:

Patients' clinical data will be collected from the patient medical record. This study is not a treatment evaluation. Patients' follow-up and treatment will be performed according to the center local practices or to the specificities of a clinical trial in which the patient would have been enrolled, depending on the recommendations given by the multidisciplinary molecular board, with the review of the tumor genetic profile.

Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer

Description of the incidence rates of each detected genetic disorder among the pre-identified target genes in the global cohort and for each histological type.

Description of the incidence rates of each detected immunologic disorder in the global cohort and for each histological type.

Comparison of the genetic and immunologic profiles between patients with the same tumor type or between tumors of different types.

Tumor response (determined by the investigator and/or the radiologist) assessed after each treatment received by the patient during his/her whole participation to the study (if data are available in the medical record).

lymphopenia, over-representation of Treg, dendritic cells alterations,

A description will be done of therapie(s) recommanded and/or received by patients based on recommandation done by the Molecular Tumor Board after reviewing of molecular profil

Progression free survival for each recommanded therapies received

Overall survival for each recommanded therapies received

Tumoral response (clinic and/or radiologic) for each recommanded therapies received

Centre Leon Berard

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Angiogenesis Inhibitors

Dominique GENRE, MD

Isabelle BOQUET, PhD

GENRE Dominique, MD

Isabelle Boquet, PhD

GRAVIS Gwénaëlle, MD

Prospective research of Matrix Metalloproteinases (MMP) 2 and 9 as predictive biomarkers in metastatic kidney cancer patients treated with 2 anti angiogenic agents (Sunitinib or Pazopanib).

The objective is to analyze the predictive impact of circulating MMP2 and MMP9 on the progression-free survival of patients with metastatic kidney cancer treated with anti-angiogenic agents (Sunitinib or Pazopanib) in comparison with two untreated cohorts (localized or oligometastatic cancer).

Prospective monocenter, open-label study

In the frame of disease management blood samples will be collected at different times of follow-up regarding disease status (localized, oligometastatic and metastatic) and tissue samples will be collected for patients scheduled for surgery.

Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents

Study of the Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents Compared to Patients Not Treated With Antiangiogenic (Localized Kidney Cancer and Oligometastatic)

date of progression (RECIST criteria), date of death

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

Institut Paoli-Calmettes

Symptoms and General Pathology

Diseases and Abnormalities at or Before Birth

Syndrome

Congenital Abnormalities

Disease Susceptibility

BAP1 Tumor Predisposition Syndrome

Patient having developed a cancerous pathology and presenting one or several anomalies of the development.

all tumor pathology associated with anomaly of development

blood and tumor samples

Sabine SARNACKI, MD, PhD

The overall project goal is to build a database of childhood cancers associated with developmental anomalies; it aims at identifying new syndromes of genetic predisposition and at enabling the further study of their molecular basis.

Most of the solid cancers arising in the childhood develop from embryonic tissues. The frequent association of paediatric cancers and abnormalities of the development underlines the link between oncogenesis and embryogenesis. However, beside the known malformative syndromes predisposing to one or several types of tumours with a variable penetrance (NF1, Wiedemann-Beckwith, Denys-Drash, Fanconi disease), associations between abnormalities of the development and tumours are badly known and little investigated, and are not listed at present systematically in the registers of child cancers.

The cytogenetic exploration of malformative syndromes associated to tumours historically allowed to describe constitutional chromosomal abnormalities of major interest for the understanding of oncogenesis pathways of the most frequent sporadic tumours (del 11p13 and WT1; del 13q14 and Rb1). So, a rare and even exceptional clinical presentation can enrich the knowledge of a common pathology. Our objective is to analyze in a detailed and multidisciplinary way the largest number of possible cases of unusual presentation associating pediatric Tumor And abnormality of Development (TAD).

Principle objective

* Registration of developmental abnormalities in pediatric patients with cancer retrospectively and prospectively for a period of three years on a nationwide scale Secondary objectives
* to record tumoral pathologies in known contexts of cancer predisposition,
* to record tumoral pathologies occurring in association with one or more developmental anomaly, these associations might have been already described or not
* to identify and locate the biological samples of patients registered in coordination with the national pediatric biobank project
* to characterize the molecular basis of the identified associations between developmental abnormalities and tumors. These molecular studies are not straight included in the present project specifically, but should be further conducted on the basis of the clinical data and thanks to the biobank network.
* a biannual analysis of aggregated data by a steering committee will be done to identify informative associations that warrant further clinical studies and biological data
* Biological studies will be performed in conjunction with local investigators and officials of the local biobank, and in coordination with the operation of BIOCAP

Tumor and Development (TED)

Identification of Patients/Families With a Paediatric Tumor and One or More Developmental Abnormalities - Characterization of New Tumor Predisposition Syndromes and Study Their Molecular Basis

Assistance Publique - Hôpitaux de Paris

Digestive System Diseases

Disease Progression

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Localized stage II/III (group 1), metastatic non resectable (group 2), metastatic potentially resectable (group 3).

Additional blood samples specific for the research will be collected. Tissue samples will be taken on surgical specimens from surgery.

Jean-Luc RAOUL, MD

Jean-Luc RAOUL, Pr

Prospective research of circulating tumor cells as markers of progression risk in colorectal cancer.

This study aims at allowing a better understanding of which circulating tumor cells (CTC) have the higher risk of metastasis of in the overall population of CTC.

Prospective monocenter open-label study.

In the frame of the management of the disease, blood samples will be collected at different times of treatment, regarding disease status (localized of stage II/III, metastatic non resectable, metastatic potentially resectable). Tissue samples will be collected for patients scheduled for surgery.

Tumoral Circulating Cells and Colorectal Cancer Progression

Characterization of Tumoral Circulating Cells According to Stage of Progression of Colorectal Cancers

Changes in the number of CTC with high risk to form metastasis, defined as an aggregation of phenotypic, molecular and functional characteristics.

Beckman Coulter, Inc.

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Squamous Cell

Blood samples to be obtained at consent, post-operatively, post-adjuvant treatment, and at follow-up or recurrence. Tumor samples to be obtained at surgery and at time of recurrence or post-treatment biopsy, if applicable.

Siddharth Sheth, MD

Rebecca Green, MSW

Gaorav Gupta, MD

Circulating tumor DNA (ctDNA) is a blood-based test that measures dying or dead cancer cells that are already circulating in the blood. In this study, the investigators will enroll patients who are planning to receive surgery to remove their head and neck cancer. The investigators are interested to learn how ctDNA levels change with surgery and over the course of time. The investigators also want to determine if there are certain features of the tumor or the patient themselves that might cause ctDNA to be higher than other patients. Also, the investigators want to explore if the detection of ctDNA following surgery is related to cancer recurrence.

The investigators will take a piece of the tumor from the surgery and determine if they can identify mutations, or changes in the genetic makeup of the cells due to cancer, that are specific to the tumor. Based on this information, the investigators will design a test using PCR, which is a technology that allows for the amplification of the DNA, that is specific to the mutation identified in the tumor. Once verified, the presence (or absence) of ctDNA in the blood can be measured. The investigators will measure this blood test prior to surgery and at multiple time points following surgery. Specimens will be collected at the time of planned clinical assessments.

Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma

American Society of Clinical Oncology

UNC Lineberger Comprehensive Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer	NCT01774409	Neoplasms	Blood and tumor...	-	Centre Leon Berard
Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents	NCT03185039	Kidney Cancer	Blood and tumor...	18 Years -	Institut Paoli-Calmettes
Tumor and Development (TED)	NCT01915797	Tumor and Abnor...	blood and tumor...	0 Days - 18 Years	Assistance Publique - Hôpitaux de Paris
Tumoral Circulating Cells and Colorectal Cancer Progression	NCT03256084	Colorectal Canc...	Blood and tumor...	18 Years -	Institut Paoli-Calmettes
Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma	NCT04099290	Head and Neck N... Carcinoma, Squa...	Blood and tumor...	18 Years -	UNC Lineberger Comprehensive Cancer Center
Predictive Impact of MMP2 and MMP9 Levels for Patients With Metastatic Kidney Cancer Treated With Anti-angiogenic Agents	NCT03185039	Kidney Cancer	Blood and tumor...	18 Years -	Institut Paoli-Calmettes

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