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NCT ID: NCT04246203 Recruiting - Pancreas Cancer Clinical Trials

Prognostic Role of Circulating Tumor DNA in Resectable Pancreatic Cancer

PROJECTION
Start date: December 12, 2021
Phase:
Study type: Observational

This is a non-randomized, multicenter, non-interventional study in patients with resectable PDAC. The patients are allocated to two observation groups according preoperative presence of ctDNA (Group A) or absence of detectable ctDNA (Group B) as determined in a liquid biopsy. After successful surgery of their pancreatic tumor and completion of local histological evaluation, tissue samples will be analyzed with regard to their mutational status with. Within 14 days before start of adjuvant tumor therapy another liquid biopsy will be taken to reassess the level of ctDNA after surgery. Patients will be monitored for disease recurrence according to harmonized, institutional standards using clinical, laboratory and (cross-sectional) imaging modalities. Accordingly, patients will be assessed every three months in the first eighteen months after surgery and every six months thereafter or based on clinical need for 36 months after the date of surgery Follow up will be documented until occurrence of relapse (or death if death occurs earlier than relapse/progression) for a maximum of 36 months after the date of surgery.

NCT ID: NCT04244500 Recruiting - Influenza, Human Clinical Trials

Burden of Influenza at Emergency Department (ED) Level in European Countries

Start date: January 27, 2020
Phase:
Study type: Observational

This study plans to conduct enhanced influenza surveillance at a hospital emergency department level independent of underlying influenza-like symptoms.

NCT ID: NCT04243499 Recruiting - Solid Tumor, Adult Clinical Trials

First-in-Human Study of ICT01 in Patients With Advanced Cancer

EVICTION
Start date: February 10, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Part 1 will be a dose escalation study of IV ICT01 (a monoclonal antibody targeting BTN3A) as monotherapy in patients with advanced solid or hematologic tumors, followed by a cohort examining the combination of ICT01 plus pembrolizumab (Keytruda). Part 2 will be a cohort expansion into 2 solid tumor indications and one hematologic malignancy for ICT01 monotherapy, and 3 solid tumor indications for the combination of ICT01 plus pembrolizumab.

NCT ID: NCT04242420 Recruiting - Cystic Fibrosis Clinical Trials

Connexin Genotypes in Cystic Fibrosis

Start date: April 2002
Phase: N/A
Study type: Interventional

Background: There is wide variety in lung disease phenotype for the delta F508 (homozygous) genotype. A leukocyte driven inflammation is most important for the pathogenesis of pulmonary disease in CF. Blood cytokines correlate negatively with pulmonary function in delta F508 homozygous patients. Gap junction proteins might be of importance for the influx of blood cells into the lung and may influence the course of pulmonary inflammation. A primary analysis (Horn et al. 2020) has shown that GJA4 variants (rs41266431) are linked to more severe disease in CF. This is very similar to variants of MBL. Aims: To assess the relationship between gap junction proteins alpha 1 (GJA1/Connexin 43) and alpha 4 (GJA4/connexin 37) genotypes and clinical disease phenotype. Moreover are GJA4 variants in terms of clinical phenotype independent of MBL variants. Methods:Patients homozygous for delta F508 get recruited from the CF centres of Bonn, Frankfurt and Amsterdam. Sequence analysis is performed for connexin 43 and 37 and MBL genotypes. Clinical disease is assessed longitudinally over 3 years by pulmonary function tests (FEV1 (forced expiratory volume in one second), FVC (=(forced vital capacity), FEF75 % (Forced expiratory flow at 75% of the pulmonary volume) pred), BMI (percentiles), P. aeruginosa colonization, diabetes mellitus and survival to end-stage CF lung disease (death or lung transplantation).

NCT ID: NCT04241328 Recruiting - Clinical trials for Cardiovascular Diseases

Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery

SYMBIOSIS
Start date: January 9, 2020
Phase:
Study type: Observational [Patient Registry]

The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.

NCT ID: NCT04240366 Recruiting - Clinical trials for Persistent or Long-standing Persistent Atrial Fibrillation

Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation

LALA-LAND-AF
Start date: December 17, 2019
Phase: N/A
Study type: Interventional

Additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial fibrillation can reduce atrial fibrillation reoccurrence within 3-12 months compared to balloon-based pulmonary vein isolation only.

NCT ID: NCT04240002 Recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Start date: September 4, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the phase 1 portion (dose escalation) of the study will be to establish an optimally safe and biologically active recommended phase 2 dose (RP2D) and/or to determine maximum tolerated dose (MTD) for gilteritinib in sequential combination with fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG). The purpose of the phase 2 portion (dose expansion) is to determine complete remission (CR) rates and composite complete remission (CRc) rates after two cycles of therapy. The study will also assess safety, tolerability and toxicities of gilteritinib in combination with FLAG, evaluate FLT3 inhibition, assess pharmacokinetics (PK), perform serial measurements of minimal residual disease, obtain preliminary estimates of 1-year event free survival (EFS) and overall survival (OS) rate and assess the acceptability as well as palatability of the formulation. One cycle is defined as 28 days of treatment. A participant completing 1 or 2 treatment cycles in phase 1 or 2 will have the option to participate in long term treatment (LTT) with gilteritinib (for up to 2 years).

NCT ID: NCT04239703 Recruiting - Clinical trials for Kidney Transplant Rejection

Trifecta-Kidney cfDNA-MMDx Study

Start date: December 1, 2019
Phase:
Study type: Observational

Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies.

NCT ID: NCT04238637 Recruiting - Clinical trials for Intrahepatic Cholangiocarcinoma

Immunotherapy Combined With Y-90 SIRT Therapy in Advanced Stage Intrahepatic Biliary Tract Cancer (BTC)

Start date: November 1, 2019
Phase: Phase 2
Study type: Interventional

A multicenter Phase II, randomized, prospective, open-label Trial investigating the clinical impact on combining Specific Internal Radiotherapy (SIRT) with the PD1-L Inhibitor Durvalumab and the CTLA-4 Inhibitor Tremelimumab in patients with intrahepatic Biliary Tract Cancer

NCT ID: NCT04236414 Recruiting - Solid Tumours Clinical Trials

Investigating Safety, Tolerability, Efficacy and PK of Olaparib in Paediatric Patients With Solid Tumours

Start date: January 14, 2020
Phase: Phase 1
Study type: Interventional

A study to find out whether olaparib is safe and well tolerated when administered to children and adolescents with solid tumours.