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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

S1400, "Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer (Screening Step) Lung-MAP Sub-Study” (CTRC #14-0036)

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

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

DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)

A clinical trial screening tool protocol has been developed to facilitate the formulation of research questions; particularly those evaluating factors related to populations that are underrepresented in clinical trials, and address cancer care disparities. This protocol is designed to allow the collection, storage and abstraction of clinical and demographic data obtained during the screening process, using the Oncology Patient Enrollment Network (OPEN), the same informatics system used by investigators participating in NCI-sponsored trials. The protocol is not a scientific study; rather, a method to implement the screening tool and allow the collection and analyses of expanded data with informed consent. The tool, based on a screening log successfully used within the NCI Community Cancer Centers Program (NCCCP)5, has been streamlined and integrated into the sites workflow by using OPEN.

Clinical Trial

ALTE1621, Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial

This phase IIb trial studies how well low-dose carvedilol works in preventing heart failure in cancer survivors exposed to high dose anthracyclines for management of childhood cancer. Patients who received high-dose anthracycline chemotherapy are at a much greater risk for developing heart failure compared to survivors who didn't get any anthracycline chemotherapy. Heart failure happens when the heart muscle has been weakened and can't pump blood as well as it should. Carvedilol may help lower the risk of cardiovascular complications.

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

NRG-BR003, A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer (CTMS# 15

This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

Clinical Trial

S1602, A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naive High-Grade Non-Muscle Invasive Bladder Cancer (CTMS# 16-0138)

This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may stimulate the immune system to fight bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.