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NCT ID: NCT04965493 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

BRUIN CLL-322
Start date: September 20, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

NCT ID: NCT04965259 Recruiting - Liver Diseases Clinical Trials

Early Detection of Hepatocellular Carcinoma in a High-risk Prospective Cohort (ELEGANCE)

Start date: April 15, 2021
Phase:
Study type: Observational

Hepatocellular carcinoma (HCC) is the 7th most common cause of cancer death globally but only 20% are diagnosed in its early stages where cure is possible. Current standard-of-care surveillance of patients at high risk of developing HCC with 6-monthly serum alpha-fetoprotein (AFP) and ultrasound imaging (US) has a sensitivity of approximately 63% for detecting early HCC. There is an urgent need for a more efficacious and convenient modality of surveillance of high-risk patients to diagnose HCC at an early stage. This prospective study aims to address this unmet clinical need by validating a panel of circulating miRNA biomarkers to develop an in-vitro diagnostic (IVD) kit for the detection of early HCC in a cohort of high-risk patients. Additionally, this study also aims to develop a multi-parametric MRI-based AI algorithm to quantify individual risks of developing HCC and to predict the progression of chronic liver disease in this cohort to enable targeted surveillance. Lastly, by identifying changes in the microbiome and metabolites as HCC develops in this cohort enables the establishment of actionable biomarkers that can prevent and predict the development of HCC.

NCT ID: NCT04964908 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Study to Understand Clinical Characteristics, Treatment Pathway in Chronic Lymphocytic Leukemia

CREEK
Start date: December 3, 2021
Phase:
Study type: Observational

A Multicenter Retrospective Study to understand the clinical characteristics, treatment pathway and resource utilization for patients with chronic lymphocytic leukemia A retrospective, multi-centre, observational study to describe disease characteristics, treatment patterns, treatment-related outcomes, and resource utilization for Chronic Lymphocytic Leukemia (CLL) patients in multiple international regions

NCT ID: NCT04961632 Active, not recruiting - Breast Cancer Clinical Trials

Dose-determining and Dose-confirmatory Study to Investigate the Optimal Dose of Tamoxifen in Breast Cancer Patients According to Genotype Status of TCF20 rs932376

Start date: December 23, 2020
Phase: Phase 1
Study type: Interventional

The investigators hypothesize that the TCF20 rs932376 locus controls endoxifen levels in estrogen receptor (ER)-positive breast cancer patients on tamoxifen therapy and that the requirement of tamoxifen dose to achieve therapeutic levels of endoxifen varies according to the genotype status of the patient's at the TCF20 rs932376 locus. Patients will receive escalating doses of tamoxifen according to their TCF20 rs932376 genotype status. Patients on 20mg tamoxifen daily for 8 weeks or longer will provide blood samples for analysis of tamoxifen and its metabolites. Patients assess with >30nM endoxifen concentrations will continue with 20mg tamoxifen dose. Patients who have endoxifen concentrations <30nM will receive dose increments of 10mg every 8 weeks until they achieve endoxifen threshold of >30nM or reach maximum dose level of 40mg/day.

NCT ID: NCT04961489 Completed - Surgery Clinical Trials

Impact of Measures Taken to Contain COVID-19 on Hospital Surgical Care Services and Clinical Outcomes

Start date: August 1, 2020
Phase:
Study type: Observational

This study aims to look at the impact on patient outcomes arising from measures implemented during the COVID-19 pandemic. The information and knowledge from this study will be useful for the management and allocation of hospital resources and patients in tne event of a disease outbreak.

NCT ID: NCT04960839 Recruiting - Breast Cancer Clinical Trials

Prophylactic Irradiation to the Contralateral Breast for BCAs Patients

PICB
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Breast cancer is the most common cancer in women worldwide, with high mortality. About 5% to 10% of breast cancers are hereditary. Most inherited cases of breast cancer are associated with germline mutations in genes, such as BRCA1, BRCA2 and PALB2. The cumulative breast cancer risk for BRCA1, BRCA2 or PALB2 mutation carriers was high. Besides the increased breast cancer risk for the inherited mutation carriers, the risk of subsequent contralateral breast cancer for the mutation carriers with breast cancer was also significantly increased. Contralateral prophylactic mastectomy was usually recommended to the breast cancer patients with BRCA mutation. However, many breast cancer patients refused the contralateral prophylactic mastectomy, due to the surgical injury, potential surgical complications, deleteriously affected body image and sexuality. Solid evidence validated that radiotherapy after surgery resulted in a reduced local recurrence for three times lower than surgery alone. It is thought that radiation would eliminate the microscopic tumors which may already exist in the breast. Thus, we proposed that for the breast cancer patients with BRCA1, BRCA2 or PALB2 deleterious germline mutations, prophylactic irradiation to the contralateral breast may reduce the risk of subsequent contralateral breast cancer. And we would like to further compare the effect of prophylactic irradiation to the published data from traditional prophylactic contralateral mastectomy.

NCT ID: NCT04958642 Terminated - Clinical trials for Niemann-Pick Disease, Type C

Adrabetadex to Treat Niemann-Pick Type C1 (NPC1) Disease

Start date: December 23, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Due to different study designs, the sponsor separated Part C into this separate registration (NCT04958642), leaving Parts A/B in NCT02534844. The trial's final results for the primary outcome measure of Adverse Events (AE) will be reported here. This study is to evaluate how safe and effective adrabetadex is for participants with Niemann-Pick Type C1 (NPC1) disease who experience neurologic symptoms (listed under Keywords). In Parts A/B (NCT02534844), two out of every 3 participants will receive the study drug. The third participant will receive 1 to 2 small needle pricks at the location where the IT injection is normally made (sham control). In Part C, all participants will receive study drug.

NCT ID: NCT04956068 Recruiting - Clinical trials for Peritoneal Metastases

PIPAC for Peritoneal Metastases

Start date: May 20, 2021
Phase: Phase 1
Study type: Interventional

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel drug delivery system that allows the direct application of chemotherapeutic agents into the peritoneal cavity. It boosts improved distribution, enhanced tissue uptake and repeatability using minimally invasive access. It was devised to palliate the local symptoms of extensive peritoneal metastases (PM) in patients who are not amenable to curative surgery. This study is to determine safety and feasibility of PIPAC in patients with PM from Gastrointestinal (GI) cancer, Hepato-Pancreato-Biliary (HPB) cancer, and other rare malignancies.

NCT ID: NCT04955990 Terminated - Clinical trials for Pulmonary Arterial Hypertension

A Study of Real-world Cohort of Pulmonary Arterial Hypertension (PAH) Participants

CARE PAH
Start date: October 14, 2021
Phase: Phase 4
Study type: Interventional

This study is designed to describe pulmonary arterial hypertension (PAH) participants in terms of their clinical characteristics, therapies used, disease progression, and outcomes (example, death, hospitalization, risk category for predicted mortality risk, and patient-reported outcomes [PROs]) in real-world clinical practice. This study will collect high-quality real-world data that may be used as a stand-alone dataset or in combination with other studies to address relevant research questions (example, serve as an external control dataset to another study) to support development and access to PAH therapies, as well as to contribute to the knowledge base of PAH through publications.

NCT ID: NCT04954859 Recruiting - Hepatitis B Clinical Trials

Long-term Follow-up Study to Evaluate Durability of Sustained Virologic Response (SVR) in Previous GSK3228836 Study Participants (B-Sure)

Start date: November 25, 2021
Phase: Phase 2
Study type: Interventional

This is a long-term follow-up study to assess durability of efficacy, as measured by SVR, in participants who have received prior treatment with GSK3228836 and achieved a complete or partial response. No further treatment with GSK3228836 will be administered in this study.