IRB Approved Clinical Projects
1. Association of Cancer Treatment with Anti-PD-1/Anti-PD-1L and Type 1 Diabetes: IRB#201232-UT:
The purpose of the study is to acquire a database which is intended for use in future research studies about the care of patients treated with Anti-PD-1/Anti-PD-1L drugs and a possible relationship to Type 1 Diabetes Mellitus (DM). Nivolumab (anti-PD-1) is a FDA approved monoclonal antibody which inhibits the programmed death receptor for the treatment of metastatic melanoma, which works by blocking a negative regulator of T-cell activation and response thus allowing the immune system to attack the tumor. Type 1 Diabetes was not described as an adverse event during Novilumab's introduction, as a successful medication for metastatic melanoma. Recently, a temporal association of Anti-PD-1 and Anti-PD-1L treatment with Type 1 Diabetes has been reported.
Development Of Type 1 Diabetes After Cancer Immunotherapy
2. Latent Autoimmune Diabetes of Adults (LADA) Database: IRB#201253-UT:
The purpose of this study is to acquire a database which is intended for use in the future research studies about the care of patients with LADA. Most patients with adult-onset diabetes are diagnosed as type 2. Adult patients with type 1 diabetes are rare. However, within the type 2 diabetes population there is an increasingly recognized group with type 1 characteristics. This group of late-onset type 1 diabetes is addressed as Latent Autoimmune Diabetes of Adults (LADA).
3. Endocrine Autoimmunity (Thyroid): IRB#201253-UT:
The purpose of the study is to establish a research database to learn more about the care of patients treated for thyroid nodules. Thyroid nodules are common with a prevalence of 50% to 67% of the general population. With the increasing use of radiographic imaging, non-palpable thyroid nodules are commonly detected during imaging studies unrelated to the thyroid (i.e., Carotid Doppler). The current guidelines recommend ultrasound (US) guided fine needle aspiration (FNA) biopsy of nodules > 10 mm or < 10mm nodules with suspicious US findings or high-risk patients. Of the patients undergoing FNA for thyroid nodules, 5-15% are found to have a malignancy. It is still unclear if the prevalence of thyroid cancer of non-palpable thyroid nodules is similar to that reported for palpable lesions. Nodules found to be benign by FNA biopsy are monitored with US evaluation every 6-12 months. FNA biopsy is repeated if there is growth of the nodule or new suspicious sonographic signs such as microcalcifications are found.
4. Coronavirus Disease 2019 severity and Vitamin D level: IRB#300724-PM:
This study is a retrospective chart review of patients who were treated for confirmed COVID-19 infection or SARS-COV2 at ProMedica Hospitals during the period 3/1/2020 to 3/31/2021. Vitamin D influence on the body’s immune system has been supported by multiple studies. 1,25(OH)2D3 is described as an immunomodulator targeting various immune cells. Vitamin D influence on the body’s immune system has been supported by multiple studies. This study will help us to find correlation between Vitamin D deficiency and increased risk and greater severity of infections.
5. CAR-Treg Islet Homing Study: IRB#301223-PM as PI:
The purpose of the study is to determine if CAR engineered, human regulatory T cells (CAR-Tregs) can home to human pancreatic islets in culture. Today, transfer of B cell antigen-specificity to T cell receptors on T cells has allowed the creation of Chimeric Antigen Receptor (CAR) T cells. The successful generation of antigen-specific CAR cytotoxic T cells against cancer suggests that a similar approach could be used to generate antigen-specific CAR Tregs with regulatory properties that may lead to suppression of antigen-specific autoreactive T cells.