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Clinical Trial

Wellness App for Sleep Disturbance in Hematological Cancer Patients

This trial aims to study the effectiveness of two different wellness-based mobile apps on blood cancer patient outcomes, including sleep, fatigue, anxiety, depression, and blood biomarkers of inflammation (TNF-a, IL-6, IL-8, CRP). The findings of this study may help physicians and researchers better understand how mobile wellness mobile apps can help in managing symptom burden and inflammation in blood cancer patients.

Clinical Trial

A Phase II multicenter, open-label, single-arm dose escalation study of Asciminib monotherapy in 2nd and 1st Line Chronic Phase – Chronic Myelogenous Leukemia (ASC2ESCALATE) (CTMS# 23-0101)

This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP-binding site TKI with discontinuation due to treatment failure, warning, or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort.

Clinical Trial

THE TEXAS HEPATOCELLULAR CARCINOMA CONSORTIUM (THCCC); RISK STRATIFICATION FOR AND EARLY DETECTION OF LIVER CANCER (U01)

TLI and UTHSCSA will be participating in projects 2 and 4 ,To examine cirrhotic patients and their risk factors for developing liver cancer . Researchers hope to improve ability to prevent liver cancer , and to better identify patients at higher risk for developing liver cancer at an early stage. C. Early detection of HCC in patients with cirrhosis remains suboptimal. The efficacy of HCC surveillance for the early detection of HCC is a subject of intense debate due to the lack of sensitive and specific biomarkers that are well validated in prospective studies. Further, implementation of surveillance in practice is very low. The MIRA aims to develop novel, urgently needed, and highly effective surveillance biomarkers of patients with cirrhosis, and improve the utilization of currently available surveillance strategies. Project 2: Metabolic Syndrome and Risk Prediction of Hepatocellular Carcinoma (PI: H El-Serag). This project will develop risk stratification algorithms based on demographic, clinical, molecular and epidemiological risk profiles to identify cirrhotic patients who might benefit from chemoprevention or intensive surveillance. Our proposed multicenter prospective cohort study of >4000 patients with cirrhosis and up to 4 year follow up (a conservative estimate of 300 new HCC cases) will be the largest cohort study of cirrhotic patients assembled in Texas (and U.S). We will evaluate phenotypic (including molecular endophenotypes) and genotypic aspects of MetS as well as established risk factors.Project 4: Novel Biomarkers for Hepatocellular Carcinoma (PI: L Beretta). This project will identify and validate novel biomarkers for risk stratification and early HCC detection. Although several biomarkers have supporting pre-clinical (phase 1) and case-control (phase 2) data, few have been evaluated in retrospective cohort (phase 3) or prospective cohort (phase 4) studies. The prospective Texas multicenter cohort study of cirrhosis patients (i.e. Phase 3) in which 300 HCC cases will be compared to 600 controls nested in this cohort. We will validate several promising existing markers as well as aim to discover novel biomarkers for HCC detection.

Clinical Trial

A Pilot Study to Evaluate the Chemopreventive Effects of Epigallocatechin Gallate (EGCG) in Colorectal cancer (CRC) Patients with Curative Resections

This will be a randomized, controlled pilot trial of patients with histological documentation of primary colon or rectal adenocarcinoma with resectable cancer, who have not received any treatments for cancer. If patient is a candidate for surgical resection, with no planned neoadjuvant chemotherapy, then the patient is eligible. All eligible subjects will be consented prior to surgery.

Clinical Trial

A Randomized Phase II Study of Partial Breast Irradiation and Sequential vs. Concurrent Chemotherapy in Women with Early Stage Breast Cancer (PBI 3.0). CTMS#: 17-0048

In a small study at Johns Hopkins, women were treated with partial breast irradiation and chemotherapy given at the same time. We are now testing in a bigger study whether giving partial breast irradiation and chemotherapy at the same time (our new method) has the same side effects and outcomes as giving partial breast irradiation and chemotherapy at different times(older method). In this study women who had their breast cancer removed but need radiation to the breast will be randomized to partial breast irradiation at the same time as chemotherapy or partial breast radiation at a different time than chemotherapy. Randomization is like flipping a coin but in this study about 2 of every 3 women will get the new method.

Clinical Trial

Demonstration of a Novel Approach Using Surface-Image Guidance to Improve Delivery of Breast Radiotherapy
CTMS#: 18-0135

The first goal of this project is to validate the superiority of semi-permanent marks used in conjunction with specialized light-based surface imaging (SIGRT) in an effort to phase out the use of permanent tattoos for the investigator's patients. The secondary goal of this project is to validate the superiority of specialized light-based surface imaging for daily radiation set-up compared to standard-of-care imaging methods using ionizing radiation, such as weekly port films or cone-beam CT (CBCT) scans during a radiation therapy course for breast cancer.

Clinical Trial

Genetics & Biology of Liver Tumorigenesis in Children

The overall goals of this Multi-Investigator Research Proposal is to further the understanding of the development and identify prognostic characteristics of liver tumors in children, particularly hepatoblastoma and its variants through a combined genomic and molecular pathology approach.