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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. 09-010-1 (Dr. Rajesh Lalla, PI): Oral Mucositis Research Registry/Repository

Oral Mucositis refers to mouth sores that occur in cancer patients due to the chemotherapy or radiation therapy that they receive. The Oral Mucositis Research studies related to oral mucositis or cancer and to identify potentially eligible subjects for future research. The Oral Mucositis Research Repository will hold in an identifiable format, any remaining tissue or blood samples or derivatives thereof for use in oral mucositis or cancer studies, at the conclusion of the study for which they were collected.

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. 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. 13-087-3.2 (Dr. Susan Tannenbaum, PI): Factors Influencing Fatigue in Breast Cancer Patients Undergoing Breast Irradiation

Study description not available

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.

IRB No. 24-094-1 (Dr. Omar Ibrahim, PI): Before-After Operational Data Collection Study Protocol - UConn

The diagnosis managment of lung nodules can be difficult. Current guidelines recommend that pulmonary nodules are managed based upon their probability of malignancy. Despite established guidelines, prior studies estimate that 60-70% of patients with ILNs are not followed up in a timely fashion in accordance with guidelines. To address the management and diagnostic challenges, Optellum has developed Virtual Nodule Clinic (VNC). VNC is an FDA-cleared, web-based, end-to-end software solution early lung cancer diagnosis. University of Connecticut Health (UConn) will be using VNC for routine clinical management of pulmonary nodule patients. As such, UConn offers an ideal environment in which to evaluate the real-world clinical utility of VNC. As part of this partnership, UConn will work with Optellum to evaluate whether use of VNC leads to an improvement in the number of pulmonary nodule patients being followed up and in the pulmonary nodule care pathway. All patients enrolled in UConn';s pulmonary nodule clinic will be eligible. The number of subjects with data collection is unspecified and will depend on the number of patients seen during different phases of the study. The data collection will have three parts: Phase 1: Baseline pre-VNC installation: operational data will be extracted from patient charts up to 6 months prior to the ';Go live'; date of Optellum';s VNC at UConn. Ramp-up period: This is the period during which UConn VNC users are being trained and migrating from their existing workflow, while the VNC workflow is being customized to their feedback. Phase 2: Active Patient Discovery post-VNC installation: operational data will be collected for the 3-12 months post-installation of VNC. During this time the Patient Discovery feature of VNC will be in active use by UConn VNC users.