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Neoplasm Malignant clinical trials

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NCT ID: NCT04620564 Active, not recruiting - Neoplasm Malignant Clinical Trials

Longitudinal Analysis of Mental Disorders, Psychosocial Distress and Care Needs of Patients and Their Relatives

LUPE
Start date: January 1, 2020
Phase:
Study type: Observational

The primary objectives of this prospective observational multicenter study LUPE are to assess the prevalence of mental disorders according to the DSM-5 (objective need for psycho-oncological support), psychosocial distress, psycho-oncological care needs and utilization of psycho-oncological support services (subjective need for support) of cancer patients and their relatives during the first months of cancer survivorship stratified by biopsychosocial factors including socioeconomic status. The investigators further aim to identify moderating and mediating as well as associated factors for psychological distress and supportive care needs. LUPE will include 2000 adult patients with solid tumor entities and one relative per patient at 4 measurement points from time of diagnosis to follow-up (+18 months) (t1: after diagnosis, t2: 6 month later, t3: 6 month later, t4: 6 month later). The investigators aim to generate a quota sample according to socioeconomic status (SES) that is representative of the German overall population. All participants will receive validated self-report questionnaires. Cancer patients will be interviewed using the standardized clinical interview SCID-5.

NCT ID: NCT04524728 Completed - Neoplasm Malignant Clinical Trials

Patterns of Treatment and Outcome of Palbociclib Plus Endocrine Therapy

Start date: December 2016
Phase:
Study type: Observational [Patient Registry]

This is a multicentre real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients. The primary endpoint is the clinical benefit rate (CBR); secondary aims are the median PFS (mPFS), overall survival (OS) and safety.

NCT ID: NCT04495790 Recruiting - Neoplasms Clinical Trials

AIMS Cancer Outcomes Study

ACOS
Start date: May 18, 2020
Phase:
Study type: Observational [Patient Registry]

The overall aim is to describe disease-free survival (DFS) in early stage cancer patients and three-year overall survival (OS) outcomes in advanced stage cancer patients receiving Advanced Integrative Oncology (AIO) treatment in a prospective consecutive case series outcomes study. We will collect data and study outcomes for patients with cancer who receive care at AIMS Institute.

NCT ID: NCT04401020 Active, not recruiting - Neoplasm Malignant Clinical Trials

First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL

Start date: July 24, 2020
Phase: Phase 1
Study type: Interventional

Primary Objective: To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in patients with relapsed and refractory multiple myeloma (RRMM) and relapsed and refractory non-Hodgkin lymphoma (RR-NHL), and determine the recommended Phase 2 dose (RP2D) Secondary Objectives: - To characterize the safety profile of SAR442257 - To characterize the pharmacokinetics (PK) profile of SAR442257 - To evaluate the potential immunogenicity of SAR442257 - To assess preliminary evidence of antitumor activity

NCT ID: NCT04200963 Completed - Neoplasms Clinical Trials

A Phase 1a/b Study of IK-175 as a Single Agent and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma

Start date: December 18, 2019
Phase: Phase 1
Study type: Interventional

This study will be conducted in adult subjects diagnosed with any form of an advanced or metastatic solid tumors including urothelial carcinoma for which standard therapy is no longer effective or is intolerable. This is a phase 1, multi-center, open label study designed to assess safety and tolerability of IK-175 as a single agent and in combination with nivolumab, to determine the recommended phase 2 dose (RP2D). Disease response, pharmacokinetics (PK), pharmacodynamics, and response biomarkers will also be assessed.

NCT ID: NCT04067388 Recruiting - Neoplasms Clinical Trials

iKnife REIMS Project

iKnife
Start date: May 2014
Phase:
Study type: Observational

There are currently no widely accepted methods which provide real time in vivo, in situ tissue diagnostics within the operating theatre environment. This project proposes that the oncological nature of in vivo tissue may be accurately identified using mass spectrometric analysis of tissue specific ions released during thermal degradation of tissue as occurs during electrosurgery. Subsequently, the protocol describes a technique for a prospective study to determine whether Rapid Evaporative Ionisation Mass Spectrometry (REIMS) can be used to accurately identify the nature of human tissue both ex vivo and in vivo.

NCT ID: NCT03986606 Recruiting - Neoplasm Malignant Clinical Trials

A Study of PSB205 in Subjects With Advanced Solid Tumors

Start date: July 5, 2019
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, Phase 1, ascending dose escalation study of PSB205 in subjects with advanced solid tumors. The study will be conducted in 2 parts. Part 1 of the study will be a dose escalation evaluation to determine the maximum tolerated dose (MTD) and to establish a recommended Phase 2 dose (RP2D) of PSB205. This study purpose is to describe the safety and tolerability, to assess Pharmacokinetics (PK) and immunogenicity, and to preliminarily assess the anti-tumor activity of PSB205 in subjects with solid tumors. Part 2 of the study will further evaluate the RP2D in 3 distinct tumor cohorts of approximately 12 subjects each.

NCT ID: NCT03911388 Active, not recruiting - Neoplasms Clinical Trials

HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors

Start date: September 12, 2019
Phase: Phase 1
Study type: Interventional

This study is a clinical trial to determine the safety of inoculating G207 (an experimental virus therapy) into a recurrent or refractory cerebellar brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication, tumor cell killing, and an anti-tumor immune response, will also be tested. Funding Source- FDA OOPD

NCT ID: NCT03873064 Recruiting - Quality of Life Clinical Trials

Body Mass Index (BMI) and Quality of Life (QoL) in Cancer Patients

BMI-QoL
Start date: January 15, 2019
Phase:
Study type: Observational

BMI is a simple and widely recorded variable that may capture obesity or cachexia in cancer patients. How BMI is associated to health-related quality of life (HR-QoL) in such patients is poorly investigated. High BMI may be associated to obesity, an increased burden of comorbidity, reduced physical activity and, in some settings, to more aggressive oncological disease. On the other hand, low BMI may reflect enhanced weight loss, cachectic syndrome, higher tumor burden and adverse prognostic features which all deteriorate quality of life. The aim of the present study is to evaluate the association of BMI and HR-QoL as measured by the EORTC-QLQ-C30 questionnaire in several cancer settings (such as localized vs metastatic or distinct primary tumors).

NCT ID: NCT03845166 Active, not recruiting - Colorectal Cancer Clinical Trials

A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors

STELLAR-001
Start date: March 20, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.