Clinical Trials

The purpose of this study is to employ mixed methods approach to develop a prostate cancer survivorship care plan (CaP-SCP) tailored to US-born Black men (USbBM), Caribbean-born BM (CBBM) and African-born BM (ABBM) using clinicians’ key informant interviews and survey of CaP Black survivors and to develop a prototype of the digitalized CaP-SCP that integrates quantitative clinical, patient reported health-related quality of life (HRQOL) and population level data to assess the sensitivity and preliminary impact of the digitalized CaP-SCP  on Health Related Quality of Life (HRQOL) using community engagement research and behavioral precision medicine.

Augmented reality (AR) immersive technology in healthcare delivers unprecedented, intuitive, realistic visualization and interaction experience for patients in a synthetic and integrated fashion. AR can help patients to manage emotions, pain, combat anxiety or fears, and make better decisions. Combined with Artificial Intelligence (AI), with benefits of accurate machine-learning models, we propose to develop an integrated AI and AR technology Prostate Cancer (CaP) Survivorship Care Plan.

The digitalized CaP-SCP development will be led by the iCCaRE consortium’s Digital Health & Human Services core. They will develop a mobile app that integrates SDOH navigation, standard CaP psycho-oncology support and emotional support. The app’s content will be delivered through AI predictive analytic and recommender system and will be based on the previously conducted interviews and focus groups. 

The digitalized CaP-SRP when used by a patient, will present the following features: 
• A series of short survey questions, which is used by the AI model to predict or recommend a specific intervention(s), educative material(s), or AR interactions with personal CaP survival stories; 
• SDOH navigation that will appropriately connect them with relevant support services and resources in their communities; 
• An emotional support intervention that can establish an empathic rapport with a CaP survivor’s sharing of his story. This will be programmed based on one of the iCCaRe Consortium’s consumer advocates; 
• The psycho-oncology support will be programmed to provide psychoeducation about the PPCD experience, reify and concretize the PPCD experience, and foster hope; 
• Patients can choose to ignore the personalized recommendations and select from a drop-down menu list of contents. 

The app is expected to be downloaded to their mobile smartphone for introduction in the clinical setting and more in-depth use at home. The survivorship care plan can be taken with participants to follow-up appointments for reminders and updates to treatments. We anticipate participants acclimating to the app for approximately 30 minutes in the clinic

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents. The first three subprotocols include the following: Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel

The primary objectives of this study are to determine if a tailored prehabilitation program focusing on functional optimization of spared limb tissue in two groups of patients with localized, lower extremity soft tissue sarcoma, one with prehabilitation and one with equal attention and informational support, improves functional outcome as measure by the Toronto Extremity Salvage Score (TESS), to identify the measures and metrics most responsive to the intervention using the (TESS), Six Minute Walk Test (6MWT)[5], wearable Heel2Toe sensor technology and daily step count, and to estimate recruitment, retention, adherence, and acceptability rates.

This protocol allows multiple treatments with TheraSphere® that may be delivered on an outpatient basis. Patients may receive a single dose to a liver lobe or segmental treatment delivered as a sequence of treatments approximately 30-90 days apart. The principal clinician, working with a multidisciplinary team, will develop a specific treatment plan for each patient, based upon the presenting condition of the patient, the vascular anatomy and the desired goal of treatment.

The purpose of this study is to evaluate how well bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

This research study is being done to look at new MRI imaging guidance software, Philips Interventional iSuite software, to see if using will improve the physician's ability to quickly place and guide needle tip position for biopsies and ablations.

This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions. InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments: A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND). After ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either: P. prophylactic PLND Q. no prophylactic PLND

The overall goal of this project is to study a new 3D ultrasound imaging technology for evaluation of axillary lymph nodes in patients with breast cancer.

This phase II trial tests how well Reishi mushroom extract works in treating fatigue and/or joint/muscle pain (arthralgias/myalgias) in patients with breast cancer on aromatase inhibitors. Fatigue and arthralgias/myalgias are common symptoms in breast cancer patients taking aromatase inhibitors (AI). Given the long duration of AI treatment for some women (up to 10 years), these symptoms can significantly impact quality of life and premature discontinuation of AIs, a beneficial medication. Reishi mushrooms are among several medicinal mushrooms that have been used for hundreds of years, mainly in Asian countries, to help enhance the immune system, reduce stress, improve sleep, and lessen fatigue. Reishi mushroom extracts have not been studied explicitly for treatment-induced arthralgias/myalgias, but have been shown to improve quality of life, muscular strength, pain, and flexibility. Information from this study may help researchers determine the effect of Reishi mushroom extract on fatigue and arthralgias/myalgias in breast cancer patients receiving an AI.

We propose a novel intensive multidisciplinary intervention based on Cognitive Behavioral Therapy (CBT) Principles to treat AIMSS. CBT based approaches are effective in managing pain, but this approach has never been used to treat AIMSS. Our plan is to complete one treatment group a month with a census of 10 patients per group totaling 50 patients treated in approximately 5 months. We will run additional groups if needed to hit our target of 50 treated patients. Fifty additional patients will be randomized to the Control arm of the study (Treatment as usual). All patients will be assessed at baseline and 3 and 6-month intervals.