Clinical Trials

The purpose of this study is to collect blood samples and fresh tissue from biopsies of metastatic lesions from Mayo Clinic patients with metastatic breast cancer. The biospecimens will be used for analysis of genetic alterations in germline and tumor DNA and for tracking of response to therapy using blood-based liquid biopsy approaches. 

The purpose of this research study is to understand the natural history of vision in patients with OPG and determine if there are factors (e.g. age at diagnosis, male/female, tumor location, features of the MRI exam, etc) that predict future vision loss or change in tumor size.

Another purpose of the study is to collect and store blood and tissue samples to use for future research to evaluate if there are certain variations in DNA, RNA, or proteins that predict the likelihood of an OPG to grow or cause vision loss.

This is a peripheral blood Collection Protocol to study the T-cell immune responses of patients with malignancies displaying one of three different patterns of antigen expression: (1) Cohort 1 focuses on cancers displaying a high (80-90%) frequency of MUC1 expression and variably high (unreported to 50%) HER2/neu (“HER2”) expression; (2) Cohort 2 focuses on primary or secondary myelofibrosis (MF) displaying mutated calreticulin (muCALR); (3) Cohort 3 focuses on glioblastoma multiforme (GBM) which often displays the cytomegalovirus tegument protein CMVpp65. Cohort 1 includes blood collections for in vitro studies which are a component of NIH-funded Project 3 within the Mayo Clinic Pancreatic SPORE, “Optimal Immunotargeting of MUC1 for Advanced Pancreatic Cancer” (Principal Investigator Dr. Gendler). Eligibility Criteria, keep current Eligibility Criteria, but precede by:: "Three cohorts of patients will be collected.:Cohort 1 includes (1) advanced unresectable pancreatic cancer, (2-4) advanced, unresectable breast cancer (up to 6 donors per phenotype: triple negative [HER2, estrogen and progesterone receptor (ER and PR) all negative], HER2 positive whatever the ER/PR status,, and HER2 negative/ER positive), (5) advanced, unresectable colorectal cancer, (6) advanced, unresectable ovarian cancer, (7) advanced, unresectable clear cell kidney cancer, (8) advanced, unresectable bladder cancer, (9) advanced, unresectable lung adenocarcinoma, (10) advanced, unresectable multiple myeloma. Also eligible are (11) up to 6 donors with triple negative breast cancer and (12) up to 6 donors with colorectal cancer who have no clinical evidence of residual (macroscopic) disease following an attempt to perform definitive treatment (including surgery, radiation and/or adjuvant or neoadjuvant chemotherapy). Cohort 2 includes (1) muCALR+ primary MF, and (2) muCALR+ secondary MF. Cohort 3 includes (1) CMVpp65 absent and (2) CMVpp65 present GBM.. Patients in all subcohorts except 1.11 and 1.12 currently have unresectable advanced or recurrent cancers, and may undergo the collection: (1) prior to initiation of systemic therapy; (2) if patient is already engaged in an ongoing cyclical systemic therapy, collection should be within three days prior to the end of the current therapy cycle, if necessary delayed until all clinical parameters are acceptable to proceed with the next planned cycle of therapy; (3) if patient is completing non-cyclical therapy, collection should be at least 2.5-3.0 weeks after completion of the therapy, or delayed until all clinical parameters are acceptable to proceed with any planned follow-up therapy. Patients in cohorts 1.11 and 1.12 (currently lacking detectable cancer) will undergo the collection at least 4 weeks after conclusion of therapy. In addition to belonging to one of these 16 subcohorts, patients will be required to have bloodwork demonstrating a blood hemoglobin ≥ 10 g/dL, a neutrophil count ≥ 1,500 /microliter, and platelets ≥ 100,000 /microliter, performed within 7 days prior to the collection.

This is a pilot study to test a hypothesis that a greater increase in serum chromogranin A (CgA) after a definitive radiotherapy (RT) with or without androgen deprivation therapy (ADT) is associated with a higher risk of prostate cancer recurrence after RT. Serum CgA level is measured before the start of RT and/or the start of neoadjuvant ADT for patients undergoing a definitive RT with or without ADT. CgA is also measured at various pre-defined post-RT time points. The study will analyze the followings: 1. Change in CgA level at various pre-defined post-RT time points from the baseline, 2. Correlation between the extent of post-therapy CgA change and Gleason score of malignancy, 3. Correlation between the extent of post-therapy CgA change and treatment outcome.

The purpose of this study is to determine if LIF (Leukemia Inhibitory Factor) level is positively correlated with disease progression and CA19-9 level in Pancreatic Ductal Adenocarcinoma (PDAC) patients and is a reliable biomarker of response.

The aim of this study is to use the combine clinical risk assessment models that are already used in routine clinical practice with information derived from polygenic risk score (PRS) testing in women of racial minorities to see if this can improve adherence to recommended breast cancer screening and prevention strategies.

The overall goal of this pilot study is to assess initial quality and feasibility of a novel protoype TBP system that may be used in the future for accurate and accessible skin cancer screening called Skinmap. Skinmap’s automatic anatomical registration will be sufficient to permit accurate alignment of baseline overlays on current imagery for visual and automated detection of changes 1mm or greater on 95% of exposed skin in baseline and current image sets. The teams of Triangulate Labs and Mayo Clinic Enterprise Dermatology propose to validate, refine, and explore the clinical utility of Skinmap.

The purpose of this research is to evaluate the efficacy of a new breast tissue assessment tool that provides new diagnostic information about breast masses and potential for early classification of malignant masses.

This study is being done to:

• Test an investigational breast imaging system;

• Image the breast and see if we can differentiate lesions by using the investigational imaging system;

• Test an investigational breast stiffness measurement method

• Test and compare to an FDA approved ultrasound stiffness imaging system (GE LOGIQ E9 (LE9)

• Compare to ultrasound images using Alpinion clinical ultrasound platform, FDA approved ECUBE 12 and a non-FDA approved ECUBE 12R

Although survivorship recommendations have been developed in areas such as lymphoma and stem cell transplant, the long-term effects of CAR-T therapy are unknown. In addition, relatively little is known about the psychosocial impact of CAR-T on survivors and their caregivers. Due to the intensive nature of CAR-T treatment and its unique side effects, including neurotoxicity in the acute setting and infections and financial burden in the long-term setting, a longitudinal study that assesses these issues in a quantitative and qualitative fashion is required. Consideration of both patient and caregiver needs is important for the provision of appropriate and effective health services, particularly in intensive cancer treatments that require a caregiver, such as CAR-T.

Our objective in this proposal is to define the long-term needs of CAR-T survivors using patient-reported health-related quality of life (QOL) measures, qualitative interviews, and adverse event data. The rationale for our proposed study is that it will provide the necessary knowledge on CAR-T survivor physical, mental, and social health to formulate a CAR-T specific survivorship program that can be implemented and studied in the future.

We aim to recruit 100 subjects (50 survivors and 50 caregivers) to the study. Inclusion Criteria are the following:  age ≥ 18, blood cancer diagnosis (including B-ALL, multiple myeloma, and lymphoma), receiving a CAR-T product, able to complete a written questionnaire in English either independently or with assistance, and able to perform a verbal interview either in person or via phone teleconference. We will survey patients at baseline and then at pre-specified timepoints up to 2 years after CAR-T. Survey questionnaires that have been previously validated in cancer populations will be used to assess: overall quality of life, psychosocial impact, cognitive function, post-traumatic stress, spiritual well-being, and financial toxicity. Patient demographics, adverse events, and comorbidities will also be collected via survey and/or medical record review. A selected subset of participants (10 survivors and 10 caregivers) will be chosen to undergo semi-structured open ended interviewing to obtain a qualitative understanding of unmet needs, social support, and distress. Data will be analyzed and compared to historical lymphoma and transplant cohorts.

This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.