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Clinical Trial

S2010, A RANDOMIZED PHASE III TRIAL COMPARING ACTIVE SYMPTOM MONITORING PLUS PATIENT EDUCATION VERSUS PATIENT EDUCATION ALONE TO IMPROVE PERSISTENCE WITH ENDOCRINE THERAPY IN YOUNG WOMEN WITH STAGE I-III BREAST CANCER (ASPEN) (CTMS# 23-0014)

This phase III trial compares the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines. The patient education tool contains interactive weblinks which provide patients with education material about breast cancer and side effects of therapy. Symptom monitoring is a weblink via email or text message with questions asking about symptoms. Hormone therapy for breast cancer can cause side effects, and may cause some women to stop treatment early. Asking about symptoms more often may help women keep taking hormone therapy medicines

Clinical Trial

Shortening Adjuvant PHoton IRradiation (SAPHIRe): A Randomized Trial of Hypofractionated Versus Conventionally Fractionated Regional Nodal Irradiation for Invasive Breast Cancer (CTMS# 23-0020)

To compare how often cancer recurs (comes back) after 3 weeks of radiation compared to 5 weeks of radiation in patients who receive radiation therapy delivered to the lymph nodes near the breast. The side effects that can develop during or after radiation treatment, including how often arm swelling (edema) happens, will also be studied

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.