Clinical trials: active, sponsored by Centre Hospitalier Universitaire de Besancon
Depression Disorder, Post Traumatic Stress Disorder PTSD
The Effects of Extreme Prematurity on Parenting
In France, perinatal mental health has become a major public health issue. Maternal mental health conditions can have serious consequences, including death by suicide.
- Trial name
- PREMA-PSY (NCT07918365)
- Volunteers
- 30 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Metastatic Colorectal Cancer
Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers
The main objective is to evaluate the impact of a Regorafenib combined with metronomic chemotherapy (capecitabine and cyclophosphamide) and low-dose aspirin compared to standard Regorafenib treatment in patients with metastatic…
- Trial name
- CARE (NCT06425133)
- Testing
- Blood sample, Quality of life questionnaires, Biopsy
- Where
- 13 sites in France
- Volunteers
- 174 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Metastatic Colorectal Cancer
Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer
This study evaluates the interest of regorafenib in combination of metronomic chemotherapies and low-dose aspirin as a 2 months induction therapy before chemotherapy initiation in the second-line metastatic colorectal carcinoma
- Trial name
- REPROGRAM-02 (NCT05462613)
- Testing
- quality of life questionnaires, Blood sample, Regorafenib
- Where
- 14 sites in France
- Volunteers
- 446 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Squamous Cell Carcinoma of the Anus Stage III
Anti-PD-1 and mDCF Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma.
Squamous cell carcinoma of the anus (SCCA) is a rare cancer, however its incidence is increasing worldwide. SCCA is mostly induced by human papillomavirus (HPV) infections (high-risk types such as HPV-16 and -18) and HPV-related…
- Trial name
- INTERACT-ION (NCT04719988)
- Testing
- Blood sample collection, Biopsy
- Where
- 10 sites in France
- Volunteers
- 55 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Advanced Biliary Tract Carcinoma
MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma
In the present TACTIC clinical trial, the investigators propose to determine the clinical interest and immunological efficacy of a treatment combining MP0317 the FAP (Fibroblast Activation Protein)-dependent CD40 agonist, with…
- Trial name
- TACTIC (NCT07036380)
- Testing
- MP0317 + Gemcitabine + Cisplatine + Durvalumab, CT-Scan, Gemcitabine + Cisplatin + Durvalumab
- Where
- 11 sites in France
- Volunteers
- 75 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Squamous Cell Anal Carcinoma, Metastatic Squamous Cell Carcinoma
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma
This study evaluates the feasibility of the combination of radiotherapy, chemotherapies (docetaxel, cisplatin and 5-fluorouracil) and spartalizumab (anti-PD-1 therapy) in patients with metastatic squamous cell anal carcinoma
- Trial name
- SPARTANA (NCT04894370)
- Testing
- Sample collection
- Where
- 4 sites in France
- Volunteers
- 10 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Renal Impairment, Digestive Cancers
DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and/or Renal Failure
Fluoropyrimidine drugs (5-Fluorouracil or 5-FU and its prodrug capecitabine) are a widely used in the treatment of numerous solid tumors in adults.
- Conditions
- Renal Impairment, Digestive Cancers, Breast Cancer
- Trial name
- DESIR (NCT07124403)
- Testing
- blood sampling
- Volunteers
- 742 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Venous Congestion
VEXUS-REA : Evaluation of Ultrasound Parameters of Venous Congestion in Patients in a Medical Intensive Care Unit
Shock is a common and serious cause of admission to intensive care. Vascular filling is one of the cornerstones of shock treatment, aimed at increasing cardiac output and restoring adequate organ perfusion through rapid…
- Trial name
- VEXUS-REA (NCT07438015)
- Testing
- Venous ultrasound (inferior vena cava, portal vein, suprahepatic vein, and renal vein to calculate the VEXUS score ; femoral vein and popliteal vein)
- Where
- France
- Volunteers
- 525 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Stage IIB Melanoma, Stage IIC Melanoma
Neoadjuvant Pembrolizumab in Patients With High Risk, Stage IIB/IIC Cutaneous Melanoma: a Single Arm Proof of Concept Phase IIA Study.
This phase II trial examine whether neoadjuvant PD-1 blockade will achieve a pathological response with manageable toxicity in stage IIB/IIC melanoma.
- Trial name
- NEOSTART (NCT07883759)
- Testing
- Pembrolizumab neoadjuvant treatment, surgery, Adjuvant treatment
- Where
- 2 sites in France
- Volunteers
- 19 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Pregnant Women
Performance and Safety of Assisted Vaginal Delivery With the Odon Device™ Versus Vacuum Extraction
This is a pivotal study designed to demonstrate the non-inferiority of the Odon Device™ versus vacuum extraction
- Trial name
- E-SAFE-ODON (NCT07862842)
- Testing
- Experimental: The BD Odon DeviceTM, Active Comparator: Vacuum extraction group
- Volunteers
- 628 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Characteristics and Management of Patients With Severe Chronic Spontaneous and/or Inducible Urticaria Refractory to Optimized Omalizumab Treatment: A French Multicenter Observational Study.
The study is sponsored by the University Hospital of Besancon under the coordination of Dr. Julie Castagna from the Department of Dermatology and Allergology.
- Trial name
- OMADROP (NCT07833696)
- Testing
- drug effect
- Where
- France
- Volunteers
- 73 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Acute Hypoxemic Respiratory Failure, Hypoxemia
Evaluation of the FreeO2 System for Oxygen Weaning After Acute Hypoxemic Respiratory Failure
Acute hypoxemic respiratory failure (AHRF) is a common condition associated with substantial morbidity, mortality, and healthcare resource utilization.
- Trial name
- EVOLUERA (NCT07794124)
- Testing
- FreeO2 automated oxygen titration system, Standard oxygen weaning
- Volunteers
- 40 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Hepatocellular Carcinoma
Identification of Innovative Biomarkers to Predict Outcomes in Hepatocellular Carcinoma Treated With Tremelimumab and Durvalumab
Several cancer immunotherapies that target the PD-L1/PD-1 pathway (i.e., checkpoint inhibitors) show promising clinical activity in patients with HCC.
- Trial name
- PREDICT-HCC (NCT06796114)
- Testing
- blood sample
- Where
- 10 sites in France
- Volunteers
- 120 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Cirrhosis, Registered on Transplant List
Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant.
The aim of this multicenter prospective interventional pilot study is to describe the evolution of myocardial fibrosis in cirrhotic patients before and after liver transplantation (LT).
- Trial name
- CARDIOFIBROCIR (NCT06327308)
- Testing
- MRI, Blood sampling
- Where
- 4 sites in France
- Volunteers
- 60 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Sleep, Video Gamers
Assessment and Characterization of Sleep Among Video Game Adult Players Without Video Game Use Disorder : a Feasability Study
The primary objective of the SLEEPLAY study is to assess the feasibility of a research protocol investigating the impact of video games on sleep in adults.
- Trial name
- SLEEPLAY (NCT07411404)
- Testing
- Sleep Assessment Protocol
- Where
- France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Antibody-mediated Rejection in Kidney Transplant
Use of Extracorporeal Photopheresis in Kidney Transplantation: Effects on Antibody-Mediated Rejection
This study aims to describe, over a one-year period, the clinical, biological, and histological evolution of a cohort of kidney transplant recipients who developed antibody-mediated rejection and were treated with extracorporeal…
- Trial name
- PETRUM (NCT07663669)
- Where
- France
- Volunteers
- 31 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Wrist Injuries, Ligament Injury
CLAP : Compare the Quality of 3D Modeling of the Wrist Based on the Cone Beam to the Gold Standard
Recent advances in personalized 3D modeling make it possible to consider personalized hand modeling based on cone-beam CT. The goal is to develop a personalized 3D modeling tool for use in routine clinical practice that reduces…
- Trial name
- CLAP (NCT07632521)
- Testing
- wrist Cone-beam CT, wrist CT scan
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Neurodevelopmental Disorders, Intellectual Developmental Disorder
High Depth Exome Sequencing on DNA From a Salivary Sample by Mouth Smear.
Despite technological advances, a genetic etiology has been identified in only about 50% to 60% of patients with Neurodevelopmental disorders (NDDs), with a higher diagnostic yield in the syndromic NDD and IDD subgroups.
- Trial name
- SEPASA (NCT07492199)
- Testing
- genetic
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Colorectal Cancer
Exploratory Study of the Relevance of a Blood Test in the Management of Patients in the Context of Colorectal Cancer Screening
Colorectal cancer (CRC) is the third most common cancer in men and the second in women with an incidence of 43,350 new cases in 2018. This incidence is increasing every year. Early detection is crucial in this pathology.
- Trial name
- PREDICT-IRFC (NCT04767568)
- Testing
- Blood sample, Tumor tissue, stool collection
- Where
- 3 sites in France
- Volunteers
- 400 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Hepatocellular Carcinoma
Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma
The TERTIO trial will propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer anti-telomerase vaccine (UCPVax) with anti-PD-L1 therapy (atezolizumab) and…
- Trial name
- TERTIO (NCT05528952)
- Testing
- Atezolizumab, Bevacizumab, UCPVax
- Where
- 14 sites in France
- Volunteers
- 105 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon