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NCT ID: NCT04598048 Active, not recruiting - Clinical trials for Cardiovascular Diseases

Quality of Life Post-ACS in Participants From EMMACE

EMMACE-XL
Start date: September 27, 2020
Phase:
Study type: Observational

EMMACE-XL will recruit participants who are survivors of acute coronary syndrome (a type of heart attack) to assess their health-related quality of life five years or more after their heart attack. We will invite surviving participants from the EMMACE 3 and 4 studies to consent to participate in EMMACE-XL study, they will be asked to complete one questionnaire relating to their health, medication and lifestyle. The questionnaire will be linked to their data collected as part of the EMMACE 3 and 4 studies including long term follow up data from NHS Digital. The data collected from all the studies will then be analysed to see if patient groups can be identified who are at risk of poorer quality of life and worse health outcomes. These groups can then be targeted with the aim of improving their health outcomes. The study will use statistical methods to look at the relationship of factors such asÍž medication adherence, comorbidities and patient demographics on health-related quality of life and health outcomes.

NCT ID: NCT04597710 Active, not recruiting - Liver Cancer Clinical Trials

Precision Medicine for Liver Tumours With Quantitative Magnetic Resonance Imaging and Whole Genome Sequencing

Precision1
Start date: February 18, 2021
Phase:
Study type: Observational

This will be a prospective, observational, cohort study to determine the impact of integrated diagnostics using quantitative magnetic resonance imaging, whole genome sequencing and digital pathology on intended patient management for liver cancer patients referred for liver resection. Participants with primary or secondary liver cancer will be recruited from Hampshire Hospitals NHS Foundation Trust in Basingstoke or Oxford University Hospitals NHSFoundation Trust in Oxford. The incidence of treatable liver tumours is on the rise globally, driven by obesity, viral hepatitis and metastases from colorectal cancers. Survival rates can be improved with optimised allocation of treatment options including surgical resection, radiofrequency ablation, embolisation, chemotherapy and targeted molecular therapies (including immunotherapy). The key motivation of this study is to help patients access the most suitable treatment combinations, based on integrating clinical, radiological and genomic data. A similar integrated approach, integrating radiology and pathology, has been shown to improve outcomes in breast cancer care. Detailed pathologic analysis of the surgical specimen from breast carcinoma biopsy provides valuable feedback to the radiologist, establishes the completeness of surgical intervention, and generates predictive information for therapeutic decisions. Whole genome sequencing (WGS) has discovered cancer driver mutations and the complex molecular profile of liver cancer. In many metastatic solid tumours, WGS has been used to identify a significant patient population (31%) who present with a biomarker that predicts sensitivity to a drug and lacked any known resistance biomarkers for the same drug. Identifying which patients possess druggable mutations will allow clinicians to make the optimal treatment decisions. The next challenge is integrating WGS into scalable clinical practice

NCT ID: NCT04597580 Active, not recruiting - Clinical trials for Breast Cancer Metastatic

Personalised Disease Monitoring in Metastatic Breast Cancer

PDM-MBC
Start date: May 8, 2019
Phase:
Study type: Observational

Patients with metastatic breast cancer may respond well to treatment and metastases can remain stable for several years. Despite personalised medicine being increasingly used for diagnosis and treatment, follow-up still include radiological response evaluation every 3-4 months, which renders a significant number of 'unnecessary' exams for patients with long-term stable disease. Increasing evidence indicates that tumour markers such as circulating tumour DNA (ctDNA), thymidine kinase 1 (TK1) and cancer antigen 15-3 (CA15-3) may be useful for disease monitoring in the metastatic setting. However, algorithms that accurately define the time-points at which imaging can be foregone or reinstituted when progression is forecast, have not been developed. This study will measure ctDNA, TK1 and CA15-3 at all imaging time-points. The primary aim is to develop an algorithm based on these biomarkers, alone or in combination, that with sufficient specificity and sensitivity can advise whether a scan can be safely admitted at a specific time-point, for patients with MBC receiving first line therapy with AI plus cyclin dependent kinase 4/6 inhibitor (CDK4/6i). Additional samples will be stored such that novel biomarkers can also be tested in future. The cost-effectiveness of using the devised biomarker protocol will be evaluated.

NCT ID: NCT04597125 Active, not recruiting - Clinical trials for Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH

Start date: November 9, 2020
Phase: Phase 4
Study type: Interventional

Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer. Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain.

NCT ID: NCT04595825 Active, not recruiting - Clinical trials for Primary Sclerosing Cholangitis

CM-101 in PSC Patients -The SPRING Study

Start date: October 1, 2020
Phase: Phase 2
Study type: Interventional

This study is designed to assess the safety, tolerability and activity of the anti-human CCL24 monoclonal antibody CM-101 in adult subjects with Primary Sclerosing Cholangitis (PSC). At least 68 subjects at approximately 50 sites will be randomized to receive either CM-101 at doses of 10 mg/kg or 20 mg/kg or matching placebo.

NCT ID: NCT04594694 Active, not recruiting - Clinical trials for Primary Biliary Cholangitis

Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC

Start date: October 2, 2019
Phase: Phase 2
Study type: Interventional

Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).

NCT ID: NCT04594369 Active, not recruiting - Clinical trials for Non-Cystic Fibrosis Bronchiectasis

A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis

ASPEN
Start date: December 1, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.

NCT ID: NCT04592913 Active, not recruiting - Clinical trials for Gastrointestinal Neoplasms

Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer

Start date: November 17, 2020
Phase: Phase 3
Study type: Interventional

This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).

NCT ID: NCT04592874 Active, not recruiting - Alzheimer Disease Clinical Trials

A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease

INVOKE-2
Start date: January 22, 2021
Phase: Phase 2
Study type: Interventional

A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.

NCT ID: NCT04590963 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer

INTERLINK-1
Start date: October 2, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer.