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NCT ID: NCT03958240 Not yet recruiting - Ovarian Cancer Clinical Trials

Deciphering Mechanisms Underlying Cancer Immunogenicity

DECIDE
Start date: September 2019
Phase: N/A
Study type: Interventional

This trial is a translational, open-label, monocentric, prospective cohort study of 900 patients aiming to describe the PD-1 (programmed death) expression in T cells (T lymphocytes) in different solid tumors. The study will be conducted on a population of patients with local and/or metastatic malignant solid tumor and who are followed for their standard of care at the IUCT-O. Patients with any of the following tumor types may be enrolled in the trial: - Head and neck cancer, - Ovarian cancer, - Cervical cancer, - Pre-invasive CIN III cervical cancer (Cervical Intra-epithelial Neoplasia III cervical cancer), - Other solid tumor types (including glioblastoma, NSCLC (Non-small cell lung cancer), anal cancer) Each tumor type will be considered as an independent cohort. For each included patient, biological specimen (tumor sample, blood samples and ascites samples if applicable) will be collected. Study participation of each patient will be 5 years.

NCT ID: NCT03958188 Active, not recruiting - Clinical trials for Small Intestine Cancer

PreOPerative Imaging of NeuroEndocrine Tumors

POPINET
Start date: March 31, 2019
Phase:
Study type: Observational

Neuro-endocrine tumours (NET) are the most frequent tumours of the small intestine. In spite of their small size, these tumours have the particularity of forming mesenteric metastasis and ganglionic secondary lesions along the superior mesenteric axis, which is in close proximity to the superior mesenteric artery (SMA). Surgery is the only cure. The complete resection being a factor for good patient prognosis, risks of subsequent local complications (occlusion, bleeding) must be discussed. The limiting factor for resectability is the arterial vascular invasion considering the risk of postoperative small bowel syndrome. At the moment, the choice of imaging examination and its related protocol is not standardized, nor the description of the tumoral mesenteric and ganglionic extension, especially the criteria of lymphadenopathy's malignancy. In addition, the complexity of SMA's anatomy and the absence of criteria for arterial invasion description may lead to a misinterpretation of preoperative imaging examination, and thus to an incomplete planning of the surgical procedure. The main objective of the current study is to improve the semiotic description of the mesenteric and ganglionic tumoral extension of small intestine NET using a technically optimized imaging examination and a standardized reading grid in order to plan the best surgical procedure which would allow maintaining a minimal length of small intestine needed to yield a satisfying quality of life and nutritional status. The secondary objective of this study is to evaluate the reproducibility of the standardized scanner's reading grid.

NCT ID: NCT03958136 Recruiting - Breast Cancer Clinical Trials

Clinico-biological Data Collection Study of Metastatic Breast Cancer

EPICURE
Start date: December 24, 2018
Phase: N/A
Study type: Interventional

RATIONALE : Currently, the mechanisms associated with the response or resistance to treatment are poorly understood and are multifactorial. These mechanisms involve clinical and biological factors associated with the host and the tumor and possibly the patient's psycho-social environment. PURPOSE : This trial will assess the use of a prospective database dedicated to patients with breast cancers that contains clinical data as well as epidemiological, psychological, emotional, social, imaging, biological and bio-pathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.

NCT ID: NCT03958110 Not yet recruiting - Concussion Clinical Trials

Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players

ON RUGBY
Start date: June 2019
Phase:
Study type: Observational

The main hypothesis is that exposure to repeated shocks is associated with a greater decrease in the thickness of optical nerve fibres. In order to show a association between the occurrence of concussions (in number and severity) and the variation in the thickness of the retinal nerve fibre layer, all participating rugby players will have an ophthalmologic examination (OCT and (retinophotography) at the beginning and end of the Rugby season.

NCT ID: NCT03957915 Not yet recruiting - Clinical trials for Mixed Phenotype Acute Leukemia

Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia

INA03
Start date: September 30, 2019
Phase: Early Phase 1
Study type: Interventional

This Phase 1 Study is an open-label, non-randomized, dose escalation, safety, efficacy, pharmacokinetic, and pharmacodynamic evaluation study of INA03 administered as a single agent IV infusion every 2 weeks to patients ≥18 years of age with R/R AML, MLL, or ALL. The study will be performed in 2 parts: a Dose Titration for Day 1 study (Part 1) followed by a Dose Escalation Part (Part 2) of INA03 used as monotherapy.

NCT ID: NCT03957863 Recruiting - Newborn Infant Clinical Trials

Study of Erythropoietin in Newborns and Children

EPO
Start date: March 12, 2019
Phase:
Study type: Observational

Erythropoietin (EPO) is a glycoprotein hormone with a molecular weight of 30.4 kDa, responsible for regulating erythropoiesis in adults, newborns and fetuses. During pregnancy, the concentration of maternal serum EPO increases linearly to allow for effective erythropoiesis over time. In the fetus, in the first 30 weeks of gestation, the liver is the main synthetic organ. Thereafter, there is a progressive transfer of the synthesis of EPO to the kidneys. In the long term, under normal conditions of oxygenation, the fetal synthesis of EPO is mainly ensured by the kidney. Because of the impossibility of making EPO tissue reserves and the inability of EPO to pass the placental barrier, the concentration of circulating EPO in the fetus reflects the balance between production and elimination. During the last trimester of pregnancy, in the absence of patent hypoxia, fetal concentrations of circulating EPO are between 10 and 50 mIU /ml, while in amniotic fluid the EPO is found at lower concentrations, between 2 and 20 mIU /ml. In adults, EPO synthesis is primarily renal, and incidentally hepatic, even if in certain pathological situations (end-stage kidney disease or polycystosis) the liver is able to take over and synthesize EPO with an electrophoretic profile similar to that of the EPO from the umbilical cord, but often in insufficient quantities. The objective of this study is to describe the forms of EPO in newborns and to compare possible iso-forms with those of adults.

NCT ID: NCT03957616 Not yet recruiting - Clinical trials for Autoimmune Encephalitis

Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis

IPNSAE
Start date: May 30, 2019
Phase:
Study type: Observational

This study aims to provide an estimate of the incidence of paraneoplastic neurological syndromes and autoimmune encephalitides in France between the years 2016 and 2018. The study will describe the incidence of antibody subtypes and regional variations.

NCT ID: NCT03956940 Not yet recruiting - Hepatocarcinoma Clinical Trials

Analysis of cfDNA in Patients With Hepatocarcinoma and Treated by Sorafenib or Regorafenib

HELP
Start date: June 2019
Phase: N/A
Study type: Interventional

The aim of this trial is to investigate whether quantitative analysis of the total concentration of circulating free deoxyribonucleic acid (cfDNA) and of the cfDNA integrity index (DII) (Intplex®) may reflect hepatocellular carcinoma (HCC) tumor dynamics or response for patients treated by Sorafenib or Regorafenib and if it could be used as a tool for patient management under targeted therapy.

NCT ID: NCT03956927 Not yet recruiting - Clinical trials for Insulin-Dependent Diabetes

Feasibility of Simulation in Therapeutic Patient Education for Adult Diabetic Patients Using the Freestyle Libre® Device

PRE-SIMPA
Start date: May 2019
Phase:
Study type: Observational

The benefits of Therapeutic Patient Education (TPE) have long been proven, but its implementation remains insufficient. It is only accessible to a part of the population and is too often limited to the acquisition of knowledge. TPE consists of supporting the patient in making decisions about his or her health, managing his or her life with the disease and treatment through the acquisition or maintenance of skills. Simulation is a pedagogical method of creating fictional or reconstructed environments in order to develop skills, know-how and abilities for which direct instruction is impossible for ethical, economic or technical reasons. To date, it is recommended for the development of caregiver skills, and has been the subject of two studies among family caregivers. It seems likely that simulation will add value to the methods currently used in TPE. To our knowledge, no studies have been conducted on simulation-based TPE (S-TPE) with patients. A consensus conference, which is a rigorous method of comparing the opinions of experts in TPE, simulation, patient experts and caregivers, was held in order to determine the learning that could be developed through simulation and the conditions of use. However, since the patient is a specific type of learner, we hypothesize that there may be some additional conditions for the use of S-TPE. And the value of this approach remains to be demonstrated. Since the use of S-TPE has never been studied with patients, a feasibility test would make it possible to evaluate, in the context of care, the possibility of its use and its acceptance by both patients and caregivers. This is necessary before considering a multicenter trial that demonstrates an interest in developing patient skills. It was decided to carry out this study in patients with diabetes, a condition for which TPE is a precursor. Caregivers will be able to objectify the advantages and limitations of using S-TPE.

NCT ID: NCT03956784 Not yet recruiting - Clinical trials for Post-operative Complications After Colorectal Surgery

E-assisted Follow up Diagnosis of Post Operative Digestive Complications

SURGICONNECT
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Postoperative management in digestive surgery has been modernized thanks to improved rehabilitation measures. These measures include an earlier refeeding, mobilization, restriction of infusions (out of a total of 22) and showed their benefit in colorectal, gastric and bariatric surgery. It is thus possible to perform sleeve gastrectomy, bypass, restorations of digestive continuity and colectomies with early discharge or one day surgery. The most serious complications (fistula, sepsis) occur in the first 10 days postoperatively with an average readmission rate of 10%. Their screening is based on clinical signs (tachycardia, pain) or biological (C-Reactive Protein (CRP) assay on Day 3 or Day 4). It is important to manage these complications early so that their morbidity is lower, resulting in shorter stays and less severity. The monitoring and safety of patients discharged early are therefore essential and for the moment poorly codified, ranging from simple nursing to follow-up via a health provider. Recently, coordination structures including nurse platform and smartphone follow up app have emerged. Thanks to this system, the patient collects his own history and biological results which allows him to be monitored continuously, as in the hospital. In case of no filling or sign of complication, the nurse platform contacts the patient. This connected follow-up would make it possible to reinforce the safety of the patient discharged early after a complex digestive procedure performed on an outpatient basis. Its benefit has been poorly evaluated but it is however more and more used by surgeons convinced of its interest especially as it goes in the direction of the development of the outpatient activity requested by the High Authority of Health with economic benefits interesting also the administration of the care structures. The purpose of the investigator's study is to evaluate the impact of e-assessed follow-up during 10 days after surgery compared to a conventional follow-up. The hypothesis is that this connected follow-up would allow earlier detection of complications requiring rehospitalization (within 48 hours), resulting in faster and less severe treatment.