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Clinical Trials: Cancer - General
IRB No. 03-203-2 (Dr. Daniel Rosenberg, PI): Identification and Analysis of Aberrant Crypt Foci in Colonoscopy Patients
Study description not available
IRB No. 08-310-1: UCONN Health Center Research Tissue Registry/Repository
The objective of this project is to develop a research repository for the purpose of performing cancer studies. Information will be gathered form UCHC medical records, molecular and pathological analysis of blood collected and tissue gathered during surgical procedures. The tissue will be obtained during surgical procedures the patient may have elected to have performed at the Health Center in the future. The collection of data will also permit review of relevant information to identify patients who may be eligible for future studies, and to seek permission of patients to be contacted to determine their interest in taking part in future studies. De-identified information will be used for approved research studies and to gather pilot data for extra-mural grant applications.
IRB No. 11-027-2 (Dr. Susan Tannenbaum, PI): UCHC Cancer Center Research Screening
Study description not available
IRB No. 14-024-2 (Dr. Adam Adler, PI): In vitro characterization of cancer related immune impairment and its reversal by the use of cytokines, costimulatory molecules and a blocker of immune suppression used singly or in combination
The trial will include patients with advanced malignancy and an estimated survival of 6 months or less, based on the judgment of their oncologist, the type of malignancy, ECOG performance status, stage of disease and pre-existing co-morbidities. This is an exploratory in-vitro study which is being performed to determine optimal combinations of cytokines, costimulatory agonists and inhibitors of immune-suppressive factors to restore immune responsiveness in patients with advanced malignancy. Patients meeting the “inclusion and exclusion criteria” will be solicited by their physician or designee to allow a venipuncture and withdrawal of 20cc of blood. The samples will be obtained, as much as feasible, along with routine blood work, so as to minimize the need for additional venipuncture. The lymphocytes will be isolated and exposed to cytokines, including, but not limited to, members of the IL1 family of cytokines [IL 1, IL 18, and IL 33. IL 36]. The cells will also be exposed to agonists for costimulatory molecules of the TNF family, including but not limited to, OX-40 and 4-1-BB. Costimulatory agonists and antagonists to B7 family will also be used, including but not limited to PD1, PD2, PD1L and CD28. An inhibitor of IDO will also be used to reduce the suppressive effects of Tregs and MDSC. The T-cells will be stimulated by vaccine recall antigens, such as tetanus toxoid and influenza antigen. Mitogens such as PMA plus Ionomycin and/or anti-CD3 monoclonal antibody will also be employed. Ki-67 staining, a marker of cell proliferation will be done to determine a Ki-67 labeling index on the study and control specimens before and after experimental manipulations. Measurements of T cell cytotoxicity and quantification of expression levels of cytotoxic effector molecules will be performed before and after experimental manipulations. RNA-Seq will be done before and after experimental manipulations of the study and control specimens to determine which genes are being transcribed in response to experimental measures. Control samples will be obtained from de-identified blood purchased from the GRC. These control specimens will be stimulated and activated in a similar fashion to the specimens obtained from the experimental subjects. If possible, the same study patients will be requested to allow a second venipuncture no sooner than 6 weeks after the first venipuncture, and in no case, no sooner than six weeks after the last antineoplastic therapy.
IRB No. 15-027-2 (Dr. Susan Tannenbaum, PI): S1207, "Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neuNegative Breast Cancer."
Primary Objective: The primary objective of this study is to compare whether the addition of one year of everolimus (10 mg daily) to standard adjuvant endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR) positive and HER2-negative breast cancer. Secondary Objectives: a. To compare whether the addition of one year of everolimus to standard adjuvant endocrine therapy improves overall survival (OS) and distant recurrence-free survival (DRFS) in this patient population. b. To evaluate the safety, toxicities and tolerability of one year of everolimus in combination with standard adjuvant endocrine therapy and compare it with standard adjuvant endocrine therapy plus placebo in this patient population. c. To determine whether the benefit of one year of everolimus use in addition to standard adjuvant endocrine therapy varies by recurrence score (RS), nodal status, or other commonly used prognostic factors. d. To evaluate adherence to 1-year treatment of everolimus in comparison to placebo in addition to standard adjuvant endocrine therapy in this patient population. e. To collect specimens in order to evaluate biomarkers of therapeutic efficacy.
IRB No. 01-127H-2 (Dr. Kazuya Machida, PI): Signalosome-oriented Phosphotyrosine Profiling of B-cell Malignancies
Study description not available
IRB No. 14-041HO-1 (Dr. Rajesh Lalla, PI): Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients (ORARAD)
The ORARAD study is a prospective cohort study to document dental and other oral outcomes in patients who receive radiation therapy as part of treatment for a head and neck cancer. Seven hundred and fifty-six participants will be enrolled nationally over a three year period. Of these, 135 will be enrolled at UCHC. All participants will be seen for the study before starting radiation therapy then at six-month intervals for up to two years after the start of radiation therapy. The primary outcome will be the two-year rate of tooth loss after radiation therapy. Secondary outcomes will include measures of dental caries, periodontal health, salivary flow, and exposed bone/osteoradionecrosis.
IRB No. 15-073-3.2 (Dr. Agnes Kim, PI): Circulating Biomarkers and Noninvasive Cardiac Imaging Techniques That predict Cancer Therapy Cardiotoxicity
The primary goal of this pilot study is to identify early signs of cardiotoxicity in patients with a wide range of cancers who are treated with anthracycline chemotherapy, alone or in conjunction with other chemotherapeutic or molecularly targeted cancer drugs, before there is irreversible cardiac dysfunction or clinical heart failure. We hypothesize that an elevation in apoptotic and inflammatory biomarkers and early changes in myocardial deformation as measured by strain imaging after exposure to anthracycline chemotherapy predict future development of cardiac dysfunction. By checking the levels of these biomarkers before chemotherapy, then at 3 months and at one year in cancer patients receiving anthracyclines, our goal is to determine whether those patients with a ""spike"" in level develop left ventricular dysfunction and/or clinical heart failure. Similarly, strain imaging by echocardiography will be performed at baseline, then every 3 months and at one year. We hypothesize that a decrease in global longitudinal strain can predict future reduction in LVEF. Our goal is to identify early those patients who are at a high risk for anthracycline-related cardiac toxicity. Early identification may lead to early institution of cardioprotective therapies (i.e. beta blockers and ACE inhibitors), which may prevent irreversible cardiac dysfunction and clinical congestive heart failure. Objectives: To determine the potential utility of biomarkers for the early identification of patients with cancer who are at risk for cardiac dysfunction. To determine whether biomarker levels, or serial changes in biomarker levels, or combination of biomarkers (activated caspase-3, troponin I, IL-6, TNF alpha, CRP, caspase-1, BNP) could predict subsequent cardiotoxicity in patients treated with anthracycline chemotherapy. To determine the utility of strain imaging in the identification of early cardiotoxicity. To determine whether cleaved caspase-3 and caspase-1 show serial changes over time during the course of cancer treatment with chemotherapy. Hypotheses: A serial increase in biomarker levels from baseline to post-chemotherapy may predict subsequent development of systolic or diastolic cardiac dysfunction. Caspase-3 as an apoptotic marker, caspase-1 as an inflammatory marker upstream of IL-1beta, IL-6 and CRP, and troponin I as cardiac injury marker can be quantified in human circulation. An elevation in the levels of these markers may indicate anthracycline-related cardiac apoptosis/ injury and associated inflammation. Strain imaging by echocardiography can identify early sub-clinical imaging evidence of cardiotoxicity. Taken together, the advanced strain imaging and novel biomarkers may identify those who are at risk of developing clinical cardiac dysfunction or heart failure. In the future, we will test whether prevention of overt heart failure can be achieved by institution of medications such as beta blocker and angiotensin converting enzyme inhibitor or angiotensin receptor blocker in these at-risk individuals.
IRB No. 13-087-3.2 (Dr. Susan Tannenbaum, PI): Factors Influencing Fatigue in Breast Cancer Patients Undergoing Breast Irradiation
Study description not available
IRB No. 20-230-2 (Dr. Kourosh Parham, PI): Prestin as a Biomarker for Hearing Loss in Cisplatin Therapy
Cisplatin is a widely used and effective chemotherapeutic agent but well-known for also causing hearing loss or ototoxicity. However, there is currently no available blood-based biomarker test to evaluate the onset of ototoxicity in patients undergoing cisplatin. Diagnostic blood tests are easy to obtain and non-invasive and can provide critical information for treatment, intervention, and even prevention of downstream pathology. Several animal studies have shown outer hair cell electromotility protein prestin to be a promising biomarker for ototoxicity, however it has yet to be applied in human studies. Our hypothesis is that prestin may present as a measurable and specific serological biomarker for early detection of ototoxicity secondary to cisplatin chemotherapy. Our specific aim is to determine a temporal relationship between prestin levels and cisplatin treatment.
IRB No. 21-211S-2 (Dr. Daniel Rosenberg, PI): Mechanisms for Early Onset Colorectal Cancer
Dr. Daniel W. Rosenberg and his project Co-Investigators are conducting a research study called "Mechanisms of Early Onset Colorectal Cancer" to examine the composition of cells that line the colon wall. Specifically, they will focus on fibroblasts, which are responsible for producing the structural framework (stroma) of connective tissue and coordinating the activities of epithelial, endothelial and immune cells in the tissue. Background & Hypothesis: Fibroblasts can exist in a number of distinct states with dramatically different activities. Resident fibroblasts in healthy tissue are non-dividing cells that help establish tissue architecture and crypt cell dynamics. However, when they are present adjacent to cancerous cells, fibroblasts can become persistently activated as cancer-associated fibroblasts (CAFs), promoting tumor growth and new blood vessel growth, while suppressing immune responses. CAFs can also become senescent and acquire an irreversible senescence-associated secretory phenotype (SASP) that establishes a "permanent" cancer-promoting microenvironment. We propose that the underlying stroma advances rapidly in EOCRC to drive early disease development. Specifically, we speculate that environmental and/or life-style factors cause abnormal fibroblast activation that negatively impacts the normal function of immunoregulatory cells within the stroma, while promoting epithelial cell division. The exploratory experiments proposed here will assess fibroblast proliferation (rapid division of cells), activation and senescence at different stages of cancer development in young patients. Understanding fibroblast dysregulation in individuals at risk of EOCRC could provide important information for understanding the factors responsible for the increasing incidence of EOCRC and ultimately point to therapeutic approaches that reduce this risk. Study Design: This study will screen 100 men or women between the ages of 30-45 years who are scheduled to undergo a routine screening or surveillance colonoscopy. Only patients found to have significant polyps, or healthy control patients, will be included in the final study population. A total target enrollment of 20 subjects (10 subjects found to have significant polyps; 10 healthy (no polyps) sex-matched controls) will fulfill this study's requirements. Main Outcome Measures/Analyses: 1) Study fibroblast populations resected near colonic lesions, 2) Classify fibroblast cell-types from colonic biopsies; Identify activated and senescent fibroblasts, 3) Define the distinguishing set of molecular alterations that characterize EOCRC cases, 4) Determine how a hyper-responsive stromal microenvironment established by activated and/or senescent fibroblasts relates to other stromal events that contribute to the rapid advancement of EOCRC.
IRB No. 23-169-1 (Dr. Benjamin Ristau, PI): Prostate cancer detection during transperineal prostate biopsy using cognitive versus software-based MRI-fusion
This study will examine differences in clinically significant cancer detection during transperineal prostate biopsy based on whether samples were obtained using a cognitive or software-based fusion technique. This will be a retrospective analysis of a multi-institutional cohort.
IRB No. 23-169H-1 (Dr. Benjamin Ristau, PI): Prostate cancer detection during transperineal prostate biopsy using cognitive versus software-based MRI-fusion
This study will examine differences in clinically significant cancer detection during transperineal prostate biopsy based on whether samples were obtained using a cognitive or software-based fusion technique. This will be a retrospective analysis of a multi-institutional cohort.