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NCT ID: NCT04659018 Completed - Colorectal Cancer Clinical Trials

Development of a Serum Test for Colorectal Cancer Screening (COLODIAG préclinique)

COLODIAG pre
Start date: August 24, 2020
Phase:
Study type: Observational

Colorectal cancer (CRC) is a major public health problem, with 44,872 new cases per year in France (3rd most common cancer), and 17,684 deaths (2nd cause of death from cancer). Colorectal cancer screening is used to detect early-stage cancers and precancerous lesions (adenomas). Detecting the disease at an early stage enables curative treatment, which is less aggressive and less costly than treatment at an advanced stage. Fecal occult blood screening has proven its effectiveness in the general population, with a 14% to 16% reduction in colorectal cancer mortality, and even a drop in incidence with 2nd generation immunological tests (FIT). In France, organised colorectal cancer screening in the general population has been in place since 2009 and since 2015 has been based on the use of a quantitative immunological test (OC-Sensor®). This test is offered every 2 years to men and women aged between 50 and 74 with an average risk of developing CRC, i.e. nearly 19.7 million people. The disadvantages of the current screening test are: - Insufficient sensitivity, although the FIT is more sensitive than the old guaiac test, its sensitivity is not perfect. - Insufficient specificity: many colonoscopies are performed for nothing. This unjustifiably exposes many patients to endoscopic complications and incurs an unnecessary cost to society. - The participation rate in screening is too low. Colorectal cancer screening participation was 32.1% in 2017/2018, below the European minimum efficiency target of 45% and far below the 71% observed in our Dutch neighbours. Several non-invasive alternatives for colorectal cancer screening are being explored and proposed. Among these techniques, serum protein assay has shown its interest in terms of screening for adenomas and colorectal cancers. The assay of 7 serum proteins (which will be the subject of a patent application in 2020), by ELISA test, is the subject of this study. These results need to be confirmed in a prospective study, with comparison to the gold standard: total colonoscopy. If these results are confirmed, this would make it possible to develop a new non-invasive method of colorectal cancer screening, which would have several advantages over the current test: better sensitivity than the FIT (estimated at about 38% for the detection of advanced adenomas and 88% for colorectal cancers) which would limit the number of false negatives and decrease the number of colorectal cancers discovered at a late stage, a better specificity which would limit the number of false positives and decrease the number of unnecessary colonoscopies, a better participation in the screening test, and a reasonable cost with a technique that can be routinely performed in many centres. Prior to this prospective clinical study, a pre-clinical calibration phase of the test (combined dosage of the 7 candidate proteins) is necessary, which is the subject of the present project.

NCT ID: NCT04658966 Completed - Preeclampsia Clinical Trials

Validation of the French Translation of a Self-questionnaire Looking for a History of Pre-eclampsia.

PRERETRO
Start date: September 18, 2020
Phase:
Study type: Observational

PRERETRO is a study for validation of the French translation of a self-questionnaire looking for a history of pre-eclampsia of more than 5 years in women who have already had a pregnancy of more than 6 months with childbirth at Brest University Hospital.

NCT ID: NCT04658862 Recruiting - Clinical trials for Urinary Bladder Neoplasms

A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

SunRISe-2
Start date: December 7, 2020
Phase: Phase 3
Study type: Interventional

The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy.

NCT ID: NCT04658823 Active, not recruiting - Cadasil Clinical Trials

Efficacy and Safety of Tocotrienols in CADASIL

Start date: December 21, 2020
Phase: Phase 2
Study type: Interventional

CADASIL is a paradigmatic cerebral small vessel disease responsible for white-matter lesions, accumulation of lacunes, microbleeds and cerebral atrophy. The disease is responsible for stroke and cognitive decline associated with motor disability. The number of incident lacunes, and amount of cerebral atrophy were recently found to have a strong relationship to cognitive decline and disability progression over 3 years in a large sample of patients. Palm tocotrienols has previously shown evidence of therapeutic effect in attenuating the progression of WMH related to sporadic cerebral small vessel disease in a randomized controlled clinical trial. We hypothesize that palm tocotrienols complex (HOV-12020) can reduce the clinical progression in CADASIL.

NCT ID: NCT04658810 Completed - Pregnancy Related Clinical Trials

Assessment of Post-traumatic Stress Disorder (PTSD) in Patients Monitored for Cytomegalovirus (CMV) Seroconversion During Pregnancy,

PTSD CMV
Start date: May 2, 2021
Phase:
Study type: Observational

Reports of maternal seroconversion to CMV during pregnancy can be extremely stressful. This virus is little known to the general public and searching for information on the Internet quickly leads to a consultation of a site mentioning the risk of severe psychomotor retardation in the event of prenatal cytomegalovirus infection. The psychological repercussions in the event of prenatal CMV infection with criteria of severity, leading or not to a request for IMG, is undeniable, but no study has investigated the consequences of seroconversion to CMV without transmission of the virus to the patient fetus, or in the case of transmission without criteria of seriousness, on the patient's experience during and after her pregnancy. Such a study would, if necessary, improve the care and support of these future mothers

NCT ID: NCT04658758 Recruiting - Clinical trials for Vein Infusion Phlebitis

The Incidence and Risk of Vein Infusion Phlebitis After Intravenous Infusion of Proton Pump Inhibitors

VeinIPP
Start date: December 4, 2020
Phase:
Study type: Observational

Intermittent or continuous proton pump inhibitor (PPI) therapy are recommended for high-risk bleeding ulcers according to the French Society of Gastroenterology. The prevalence of incidence of vein infusion phlebitis after PPI intravenous infusion is high in geriatric acute ward (about 10% of severe vein infusion phlebitis). The primary of objective of the study is to determinate the prevalence of vein infusion phlebitis after PPI intravenous infusion in aging people. The secondary of objective of the study if to determinate the factors of risk of vein infusion phlebitis.

NCT ID: NCT04658472 Active, not recruiting - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Proof-of-concept Study for SAR445088 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Start date: April 28, 2021
Phase: Phase 2
Study type: Interventional

Primary Objectives: - Part A: Efficacy of SAR445088 across three subpopulations of CIDP patients: standard of care (SOC)-Treated, SOC-Refractory and SOC-Naive - Part B:Long-term safety and tolerability of SAR445088 in CIDP Secondary Objectives: - Part A: - Safety and tolerability of SAR445088 in CIDP - Immunogenicity of SAR445088 - Efficacy of SAR445088 with overlapping SOC (SOC-Treated group) - Part B: - Durability of efficacy during long-term treatment with SAR445088 in CIDP - Long-term immunogenicity of SAR445088 in CIDP

NCT ID: NCT04658459 Recruiting - Clinical trials for Interphalangeal; Osteoarthritis, Proximal (Bouchard)

Results of the Tactys Implant in Proximal Interphalangeal Joint Arthroplasty

Start date: January 1, 2015
Phase:
Study type: Observational

Study at middle term of the functional and radiographic results of proximal interphalangeal joint arthroplasty with the Tactys prothesis. The aim is to evaluate if the short term results are maintained in time.

NCT ID: NCT04658407 Not yet recruiting - Clinical trials for Fulminating Hepatic Failure

Patients' Outcome With Severe or Fulminant Hepatic Insufficiency, Hospitalized in the Public Hospitals of Paris

DEVINHEF
Start date: April 1, 2021
Phase:
Study type: Observational

The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe, fulminating acute liver failure in the public hospitals of paris.

NCT ID: NCT04658381 Completed - Albinism Clinical Trials

Genetic Analysis and Multimodal Retinal Imaging of Asymptomatic Fovea Plana Cases in the General Population

APOGEE
Start date: December 17, 2020
Phase: N/A
Study type: Interventional

Albinism is a genetic condition, resulting from mutations in at least 19 known genes responsible for the production of melanin in the skin, hair and eyes. Ophthalmological manifestations are a constant feature of this disease. Albinism is believed to be responsible for 5% of visual impairments worldwide and all albino patients have some degree of fovea plana. In the milder forms, it is a slightly less marked foveolar depression with conservation of the normal diameter of the cones and, therefore, good visual function. In addition to its known association with various ocular pathologies such as albinism, aniridia, nanophthalmia and retinopathy of prematurity, fovea plana was found in 3% of a population of normal children (without known ocular or systemic pathology) in a study conducted in 2014 to determine a pediatric normative basis for macular volume measured by optical coherence imaging (Stratus OCT). More recently, a study carried out at the Hospital Foundation Adolphe de Rothschild showed that at least 35% of parents of albino children, who are totally asymptomatic, present with fovea plana in OCT. This frequency is higher than the 3% prevalence of fovea plana in asymptomatic subjects without a family history of albinism, suggesting a modulation of heterozygosity for a known gene for albinism. The aim of this study is to verify, in patients with fortuitously discovered fovea plana (preoperative OCT for cataract surgery), with conservation of visual function and without known or manifest albinism, whether they are carriers of mutation in one of the genes referenced for albinism. This will also allow us to characterize these foveolar profiles in OCT according to the classification of Thomas et al., as well as in terms of retinal capillary density in OCT-Angiography, in order to know whether it is the same type of fovea plana or if the phenotype differs depending on the genetic damage.