Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Kidney Diseases

Adenocarcinoma

Carcinoma, Renal Cell

Urologic Neoplasms

Urologic Diseases

Urogenital Neoplasms

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Coagulants

Angiogenesis Inhibitors

Adjuvants, Immunologic

Platelet Factor 4

Patients having a radical or partial nephrectomy.

Patients treated by RCC-directed targeted therapy

2 blood samples of 10mL + one urine sample

* on pre-operative d-1/d, post-operative d1 and d5(+/-2),
* one month post-operative,
* at the end of the study in the absence of disease progression or at the date of recurrence or progression if the case arises.

Biological sample

2 blood samples of 10mL + one urine sample

* before starting the therapy
* at first therapeutic evaluation (2 or 3 months depending on the treatment chosen)
* at the end of the study or at the date of disease progression.

Jean-Christophe BERNHARD, Dr

Despite novel treatment options, Renal Cell Carcinoma (RCC) has been characterized by a constant increase in its mortality and consequently requires an important involvement in translational research.

The aim of this study is to evaluate the interest of CXCL4, CXCL4L1 and CXCR3 as biomarkers in localized, locally advanced or metastatic RCC. Indeed these chemokines have shown anti-angiogenic and anti-tumor properties in experimental models and may be particularly interesting for prognostic and predictive purposes.

Based on a physiopathological rationale, the use of RCC-directed antiangiogenic therapies into clinical practice leads to conclusive results and makes RCC a particularly well-suited tumor type to study factors involved in the angiogenic process. Furthermore the intensive use of targeted therapies in clinical practice raised new questions about their management.

Therefore the identification of new molecular biomarkers is important:

* to improve the precision of prognostic models currently based on clinical, biological or histopathological variables
* to identify high risk patients that could benefit from an adjuvant treatment or a closer postoperative follow-up
* to predict the response to antiangiogenic therapies and therefore identify the drug which is likely to be the most effective within an ever increasing pharmacopeia
* to follow the therapy as precisely as possible, predict or attest the disease progression justifying a therapeutic modification

Low CXCL4, CXCL4L1 and CXCR3 tumor expression levels are associated with bad prognosis factors in RCC. Consequently their interest in RCC is worth being evaluated, in two subgroups : Localized / locally advanced renal cell carcinoma and Metastatic renal cell carcinoma.

Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma

Prognostic value of the markers of interest (CXCL4, CXCL4L1 et CXCR3) will be evaluated by the association of these markers with time to event occurrence.

Localized or locally advanced renal cell carcinoma group:

* local recurrence
* contralateral recurrence
* extra-renal distant recurrence (metastatic progression)
* specific cancer death
* nonspecific cancer death

Metastatic renal cell carcinoma group :

* local recurrence for patients who underwent a nephrectomy
* contralateral reccurence
* metastatic progression
* specific cancer death
* nonspecific cancer death

Predictive value of therapeutic response will be assessed for patients receiving systemic therapy. It will be evaluated by the association of markers of interest with the therapeutic response.

* RECIST criteria: patients showing a complete response or a partial response, will be considered as "responders"
* The progression of the longest diameter of tumor, the proportion of intra-tumor necrosis (Choi criteria) and +/- the perfusion characteristics of tumor if primitive tumor

University Hospital, Bordeaux

Skin and Connective Tissue Diseases

Melanoma

Nevus, Pigmented

Nevus

Nevi and Melanomas

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Evaluate the effectiveness of dosimetry feedback on sun exposure behaviors, attitudes, and awareness in patients diagnosed with melanoma.

Assess the relationships between UV camera score, silicone mold of a skin patch, phenotypic evaluation and sun-exposure behaviors. Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.

Determine the relationship between measures of sun exposure and genomic characteristics of tumors in melanoma patients. Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.

This is a sub-study that involves a behavioral intervention. Participants will wear a UV dosimetry for 3 weeks, return the device and receive feedback. After the feedback, they will re-wear the device for an additional 3 weeks.

UV Counseling

Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.

UV Photo

Biological Sample

Neil Box, PhD

This research study is designed to better understand the role of genetics, sun-exposure and phenotypic factors in melanoma.

Patients will have the opportunity to participate in a questionnaire and then they are given the option to participate in substudy A (wear a UV dosimeter, complete questionnaires, and receive feedback based on the UV dosimeter results), subtstudy B (wear a skin patch, participate in a UV photo analysis, answer questionnaires), and/or substudy C (give biological samples via nevi).

Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma

A short questionnaire is administered during the clinic visit to assess sun exposure behaviors of melanoma patients. The data gathered from this questionnaire will help identify possible trends in sun exposure behaviors and provide a baseline dataset for future research,

Identify the difference between self-reported sun exposure behavior and actual UV exposure by having patients wear individual dosimeters

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a sun exposure questionnaire

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a sun exposure questionnaire

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a UV photography

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a UV photography

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a silicone casts

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a silicone casts

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in melanoma patients using a SCINEXA exam.

Determine the relationship between UV camera score, skin patch, sun exposure history, and phenotypic evaluation in non-melanoma patients using a SCINEXA exam.

Determine whether UV exposure and camera scores correlates with UV signature (somatic) mutations and other tumor-related mutations in clinically benign nevi and primary melanomas using saliva samples, benign nevi, and primary melanomas. Next Generation Sequencing (NGS) will be used to obtain the genetic information from all samples.

Determine self-reported sun exposure behaviors through participant interviews. Questions are related to time spent outside, and what attempts to be sun-safe occurred while outside.

Participants will receive a personalized feedback plan and the success of the plan will be measured through individual dosimetry. We will track real time change in sun exposure based on repeat UV dosimetry.

Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of genomic DNA

Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of somatic mutations

Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV exposure history

Determine if a relationship exists between the phenotypic attributes of benign nevi through analysis of analysis of UV camera scores with the clinical presentation

Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of genomic DNA

Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of somatic mutations

Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV exposure history

Determine if a relationship exists between the phenotypic attributes of primary melanomas through analysis of UV camera scores with the clinical presentation

University of Colorado, Denver

Symptoms and General Pathology

Neoplastic Cells, Circulating

Neoplasm Metastasis

Neoplastic Processes

Cohort1: Cohort of patients with stage III inoperable or IV metastatic melanoma This cohort will enable the achievement of objectives 1 (proof of concept) and 2 (establishment of prognostic and predictive value).

Cohort 2: Cohort of patients with melanoma who are candidates for sentinel lymph node analysis.

This group includes patients with melanoma in whom sentinel lymph node testing is performed. According to current French recommendations, these are patients whose primary melanoma has a Breslow index (thickness) of more than 1 mm or ulcerated primary melanoma (loss of the epidermis).

Biological sample performed :

* before treatment
* 1 months after the beginning of treatment
* every tumoral assessment

Celeste Lebbe, MD PhD

Matthieu RESCHE-RIGON, MD PhD

laetitia Da Meda

Several studies conducted over the past decade have shown that Circulating tumor cells (CTCs) can be used as a marker for predicting disease progression and survival in patients with early or metastatic cancer. A high number of CTCs correlate with aggressive disease, increased metastasis and decreased survival rates.

Knowledge of metastasis mechanisms was mainly obtained from mouse models with CTCs after orthotopic transplants. The only possibility to study the patient's CTC subpopulations is to carry out ex-vivo expansion and develop an animal model with CTC xenograft. Because circulating blood collection is simple and non-invasive, CTCs can be used as a marker to track disease progression and survival in real time. CTCs could also guide therapeutic choice.

Ex Vivo Expansion of Circulating Tumor Cells as a Model for Cancer Predictive Pharmacology

Expansion ex Vivo Des Cellules Tumorales Circulantes Comme modèle de Pharmacologie prédictive Des Cancers. EXPEVIVO-CTC

Occurrence of clinical benefit (defined as Complete Response (CR), Partial Response (PR) or stable disease (SD)) and progressive disease based on the best overall response which depends on the tumour evaluations assessed using RECIST 1.1 criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma	NCT01339975	Carcinoma Carcinoma Renal... Kidney Neoplasm... Kidney Diseases Chemokines	Biological samp... Biological samp...	18 Years -	University Hospital, Bordeaux
Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma	NCT01339975	Carcinoma Carcinoma Renal... Kidney Neoplasm... Kidney Diseases Chemokines	Biological samp... Biological samp...	18 Years -	University Hospital, Bordeaux
Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma	NCT03783325	Nevi and Melano...	UV Counseling UV Photo Biological Samp...	18 Years -	University of Colorado, Denver
Ex Vivo Expansion of Circulating Tumor Cells as a Model for Cancer Predictive Pharmacology	NCT03797053	Melanoma Circulating Tum...	Biological samp...	18 Years -	Assistance Publique - Hôpitaux de Paris
Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma	NCT01339975	Carcinoma Carcinoma Renal... Kidney Neoplasm... Kidney Diseases Chemokines	Biological samp... Biological samp...	18 Years -	University Hospital, Bordeaux
Assessing Gene-Environment Interactions in Clinical Presentation of Nevi and Melanoma	NCT03783325	Nevi and Melano...	UV Counseling UV Photo Biological Samp...	18 Years -	University of Colorado, Denver

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