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Clinical Trials: Cancer - General
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. 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. 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. W24-026-1 (Dr. Swarup Kumar, PI): A Phase 3 Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma who have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide (MajesTEC-9)
Teclistamab (also named JNJ-64007957) is an experimental medication being studied in this research study to see if it may be beneficial in the treatment of multiple myeloma. The purpose of this study is to see how teclistamab by itself compares to treatment combinations that are commonly used to treat multiple myeloma. These treatment combinations are either pomalidomide, bortezomib and dexamethasone (called PVd) or carfilzomib and dexamethasone (called Kd).
IRB No. 25-374-1 (Dr. John Birk, PI): Using Automated Biochips to Assist in Specific Chemotherapy Selection in Pancreatic Cancer Patients
This research study is evaluating a new laboratory technology called the Encapsulate Biochip, which is designed to test how tumor cells, such as those from pancreatic cancer, respond to different chemotherapy drugs. The goal of this research is to explore whether this technology could eventually help doctors select more personalized and effective treatments for cancer patients. Participants in this study will be individuals who are already scheduled to undergo a standard diagnostic procedure called endoscopic ultrasound with fine-needle aspiration (EUS-FNA) at UConn Health as part of their routine evaluation for possible pancreatic cancer. If enough tissue is collected for diagnostic purposes during the EUS-FNA, a small additional biopsy sample will be taken at the same time for research purposes. This extra sample will not affect clinical care or the diagnosis. It will be de-identified (coded) and sent to the Encapsulate laboratory for testing using the Biochip system. There are no extra visits or procedures required as part of this study beyond what the patient would already undergo for their medical care. After the EUS-FNA procedure, the participants will continue to follow up with their treating physician/oncologist per standard care, and the clinical study investigators will review the participants' medical records over the following 3 to 6 months to gather information about their diagnosis, treatment plan, and outcomes. This study is considered to pose only a slight increase over minimal risk, as it involves no significant additional procedures beyond those already associated with the participant';s standard-of-care EUS-FNA. The additional research biopsy collected during the EUS-FNA procedure is small in size and only obtained after adequate tissue has been secured for diagnostic purposes. As such, the added risk to participants is minimal and primarily limited to a possible slight increase in procedure time and the theoretical risk of complications related to the extra biopsy sample.