Neoplasms

Nervous System Diseases

All Conditions

Central Nervous System Neoplasms

Nervous System Neoplasms

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Dermatologic Agents

Chlorhexidine

Bevacizumab

Chlorhexidine gluconate

The information letter will be delivered by the investigator physician to the patients to inform them on the study, its implementation and their complete freedom to participate or not.

Clinical Data and Questionnaires:

1. For the retrospective part

   * Patient identification based on data from the Medical Information Department (DIM) of the ICM;
   * Verification of the eligibility criteria;
   * Inclusion of patients in a coded form in BDD-NO;
   * Implementation of the database with the data already collected (as an coded EXCEL file) in specific studies (some patients are included in several of these studies): study of diffuse low grade gliomas, study on anaplastic gliomas, study on the place of Bevacizumab in high-grade gliomas, clinical database created
   * Collection of clinical data from each patient's medical record
2. For the prospective part

   * Inclusion of patients in a coded form in BDD-NO;
   * Collection of clinical data from each patient's medical record.

Diagnostic data : date and description of first symptoms,date of radiological diagnosis, tumor localization, number of lesions, date of histological diagnosis, histological diagnostic mode, histological diagnosis, WHO grade (I, II, III or IV), immunohistochemic data, molecular alterations therapeutic sequence : type of treatment, baseline exam before each treatment, surgery, radiothérapy, systemic treatment, clinical study, follow up until death

data collection

Jean-Pierre BLEUSE, MD

amelie DARLIX, MD

Michel FABBRO, MD

Amélie DARLIX, MD

the creation of a clinical database including data for all PCNST patients is of high interest. This database will allow us to develop clinical studies on:

* The clinical, radiological and biological presentation of tumors, the impact of oncological treatments and the evaluation of survival for the different subtypes of Primary central nervous system tumors (PCNST). This is particularly important for rare histological subtypes of PCNST for which the current knowledge is scarce;
* Clinical, radiological and biological factors predictive of tumor response to treatments;
* Prognostic factors.

Primary central nervous system tumors (PCNST) correspond to all primitive tumors involving central nervous system structures, meninges and the origin of the cranial and paraspinal nerves. They have a malignant, benign, or borderline evolution. TPSNC represent a heterogeneous group of tumors, with more than 140 subtypes described in the WHO classification. The causes, prognostic factors, and therapeutic management differ according to the histological subtype.

The incidence of all of TPSNCs ranges from 17.6 to 22.0/105 in North American and European studies. However, because of the high number of different histological subtypes, most of them must be considered as rare tumors. Moreover, they represent a major public health problem due to high morbidity \[8\] and mortality.

In this context, the creation of a clinical database including data for all PCNST patients is of high interest. This database will allow us to develop clinical studies on:

* The clinical, radiological and biological presentation of tumors, the impact of oncological treatments and the evaluation of survival for the different subtypes of PCNST. This is particularly important for rare histological subtypes of PCNST for which the current knowledge is scarce;
* Clinical, radiological and biological factors predictive of tumor response to treatments;
* Prognostic factors.

The database will also allow us to develop or participate in multicentric clinical studies, at the national or international level, as well as to facilitate the identification of patients for inclusion in translational studies

Creation of a Clinical Database on Primary Nervous System Tumors

collection of clinical data in the medical record

obtaining reliable clinical data for write new clinical trials project

new clinical trials project based on this clinical database

Institut du Cancer de Montpellier - Val d'Aurelle

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Creation of an ambispective (retrospective and prospective), multicentric and European clinical database for surgery with robotic assistance in rectal cancers with implementation in France and then in Europe

Clinical database

Philippe Rouanet, MD

The laparoscopic approach for total mesorectal excision (L-TME) results improved short-term outcomes. However this approach has technical limitations when the pelvis is narrow and deep. Indeed there is a limited mobility of straight laparoscopic instruments and associated loss of dexterity, unstable camera view and compromised ergonomics for the surgeon. Robotic technology was developed to reduce these limitations and offers the advantages of intuitive manipulation of laparoscopic instruments with wrist articulation, a 3-dimensional field of view, a stable camera platform with zoom magnification, dexterity enhancement and an ergonomic operating environment. A major advantage of the robotic approach is the surgeon's simultaneous control of the camera and of the two or three additional instruments. This advantage facilitates traction and counter-traction. The technological advantages of robotic surgery should also allow a finer dissection in a narrow pelvic cavity.

The laparoscopic approach for laparoscopic total mesorectal excision (L-TME) results improved short-term outcomes and provides a clearer intraoperative view compared with the open approach in a deep and narrow pelvis. Preliminary results from the COLOR II trial confirmed improved patient recovery and similar safety, same resection margins and completeness of resection using L-TME compared with the results achieved with open surgery.Results from the CLASICC trial supported the use of laparoscopic surgery for colorectal cancer and showed no difference between laparoscopically-assisted TME and conventional open resection at 10 years post-procedure in terms of overall survival, disease-free survival and local recurrence.

Despite these positive clinical outcomes for L-TME, laparoscopic resection of rectal cancer, especially in a deep and narrow pelvis, is technically demanding and demands a long learning curve. Technical limitations include limited mobility of straight laparoscopic instruments and associated loss of dexterity, unstable camera view and compromised ergonomics for the surgeon. These limitations could explain the conversion rate which remained at 17% in the last COLOR II trial.2 In order to avoid this drawback, we have described for patients with high-risk of conversion, the trans-anal endoscopic proctectomy (TAEP) approach performed with the Transanal Endoscopic Operation (TEO) device.This trans-anal procedure is also called trans anal minimally invasive surgery (TAMIS) if a laparoscopic port is used.

Robotic technology was developed to reduce these limitations and offers the advantages of intuitive manipulation of laparoscopic instruments with wrist articulation, a 3-dimensional field of view, a stable camera platform with zoom magnification, dexterity enhancement and an ergonomic operating environment. A major advantage of the robotic approach is the surgeon's simultaneous control of the camera and of the two or three additional instruments. This advantage facilitates traction and counter-traction. The technological advantages of robotic surgery should also allow a finer dissection in a narrow pelvic cavity. However, total robotic surgery for rectal cancer is still technically challenging and involves two operative fields (splenic flexure and rectum), potential collision of the robotic arms and lack of tactile feedback.

Reports of robotic and laparoscopic rectal cancer surgery outcomes showed similar intraoperative results and morbidity, postoperative recovery and short-term oncologic outcomes.However, longer operation times have been described as a disadvantage of the robotic system, compared with conventional laparoscopy. On the other hand, all meta-analyses comparing robotic total mesorectal excision (R-TME) and L-TME concluded in reduction of the conversion rate.

Since 2007, the rectal surgery with robotic assistance is booming. To date, seven meta-analyzes have been published. All show that the robot exceeds laparoscopy to reduce the conversion rate. The last two meta-analyzes that had gathered more than 800 patients undergoing robotic surgery have again highlighted the contribution of the robot to secure the radial margin and decrease sexual sequelae. However, there is not so far from Phase 3 randomized trial dealing with the subject. The ROLARR protocol was completed in late 2014 (Ph III laparoscopy / Robot), the first results are published in late 2015.

The interest of a European multicenter ambispective (retrospective and prospective) database is fundamental because this early work suggests that the robot can make more for specific subgroups of patients, particularly in high surgical risk patients (Male, narrow pelvis, high BMI, mesorectal fat, large tumor of the anterior and middle third).

The largest series of R-TME stems from the US national cancer database (965 patients operated by R-TME) and confirms a 9.5% conversion rate compared to 16.4% with L-TME (p \< 0.001).

Robotic Low Rectum Anterior Resection

European Ambispective Cohort of Rectal Cancer Patient Who Underwent Robotic Low Anterior Resection

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Neoplasm Metastasis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

The various clinicam database will be collected solely to meet the objectives of the study.

All data collected to create the database for this project will be anonymized

clinical database

Emmanuel DESHAYES, MD

Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases.

bone metastases frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy.

Bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment.

Xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.

Since 13 November 2013, XOFIGO has been authorised on the European zone for the treatment of patients with prostate cancer, in the phase of resistance to castration, with symptomatic bone metastases. Prostate cancer is the most common non-cutaneous cancer in men internationally, and more than 90% of patients with hormone-resistant prostate cancer will have bone metastases.

They frequently give rise to "bone events" that include spinal cord compressions and pathological fractures requiring surgery or external radiotherapy.

Bone metastases are an important cause of death, disability, quality of life degradation and increase the cost of treatment.

There is therefore a need for bone-targeting therapeutic agents that provide a benefit in terms of survival.

Xofigo is indicated in patients with bone metastases symptomatic of hormone-resistant prostate cancer and without known visceral metastases.

This treatment appears to have fewer side effects than chemotherapy (and does not call into question subsequent chemotherapy) or that the currently available metabolic bone radiotherapy as well as better pain control and survival gain than the latter do not

Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO

Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO Prescribed by AMM in Prostate Cancer

clinical data collection in the medical record

Crohn Disease

Colitis

Colitis, Ulcerative

Ulcer

Prolapse

Diverticulitis

Rectal Prolapse

Inflammatory Bowel Diseases

Gastroenteritis

Colonic Diseases

Pathological Conditions, Anatomical

Diverticulum

Diverticular Diseases

Pelvic Organ Prolapse

Constitution of a prospective, multicenter clinical database of surgery with robotic assistance in colorectal pathologies

Evaluation of robot Da Vinci Xi by determining its learning curve.The operating time will be defined by patient then the operating average will be calculated.

Since the emergence of minimally invasive technology twenty years ago, as a surgical concept and surgical technique for colorectal cancer surgery, its obvious advantages have been recognized.

Laparoscopic technology, as one of the most important technology platform, has got a lot of evidence-based support for the oncological safety and effectiveness in colorectal cancer surgery Laparoscopic technique has advantages in terms of identification of anatomic plane and autonomic nerve, protection of pelvic structure, and fine dissection of vessels.

But because of the limitation of laparoscopic technology there are still some deficiencies and shortcomings, including lack of touch and lack of stereo vision problems, in addition to the low rectal cancer, especially male, obese, narrow pelvis, larger tumors, it is difficult to get better view and manipulating triangle in laparoscopy. However, the emergence of a series of new minimally invasive technology platform is to make up for the defects and deficiencies. The robotic surgical system possesses advantages, such as stereo vision, higher magnification, manipulator wrist with high freedom degree, filtering of tremor and higher stability, but still has disadvantages, such as lack of haptic feedback, longer operation time, high operation cost and expensive price.

3D system of laparoscopic surgery has similar visual experience and feelings as robotic surgery in the 3D view, the same operating skills as 2D laparoscopy and a short learning curve. Transanal total mesorectal excision (taTME) by changing the traditional laparoscopic pelvic surgery approach, may have certain advantages for male cases with narrow pelvic and patients with large tumor.

No prospective study has compared these four surgical techniques. Furthermore, the learning curve still remains a crucial problem in term of data interpretation.

We will collect synchronized videos and data on surgeon performance during colorectal surgeries using the Vinci Logger (dVLogger, Intuitive Surgical, Inc.), it is a personalized recording tool that captures synchronized video in the form of endoscope view at 30 frames per second. Kinematic data included characteristics of movement such as instrument travel time, path length and velocity. Events included frequency of master controller clutch use, camera movements, third arm swap and energy use.

We will explore and validate objective surgeon performance metrics using novel recorder ("dVLogger") to directly capture surgeon manipulations on the daVinci Surgical System.

Clinical Database of Colorectal Robotic Surgery

French Prospective Clinical Database of Colorectal Robotic Surgery

This questionnaire assessed the bowel function of patient. The range is from 8 (low function) to 35 (high function)

The range is from 1 (low erectile function) to 27 (high erectile function)

The range is from 3 (low sexual function) to 55 (high sexual function).

The range is from 0 (low urinary function) to 40 (high urinary function).

The quality of the mesorectum resection is determined by the pathologist according to the aspect of mesorectum, the circumferential resection margin, cone effect .

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Creation of a Clinical Database on Primary Nervous System Tumors	NCT04516720	Nervous System ...	data collection	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Robotic Low Rectum Anterior Resection	NCT04015804	Rectum Cancer	Clinical databa...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Robotic Low Rectum Anterior Resection	NCT04015804	Rectum Cancer	Clinical databa...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Evaluation of Tolerance and Efficacy Retrospective Data of XOFIGO	NCT04516707	Prostate Cancer Bone Metastases Hormone-resista...	clinical databa...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Robotic Low Rectum Anterior Resection	NCT04015804	Rectum Cancer	Clinical databa...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Clinical Database of Colorectal Robotic Surgery	NCT04013152	Crohn Disease Polyposis Ulcerative Coli... Diverticulitis Colorectal Tumo... Rectal Prolapse Benign Colorect...	Clinical databa...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Robotic Low Rectum Anterior Resection	NCT04015804	Rectum Cancer	Clinical databa...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle

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