Clinical Trials

A cardinal feature of the rare disease Bardet-Biedl syndrome (BBS) is obesity. The purpose of this study is to examine physical activity and sleep behavior in individuals with BBS using a wrist-worn accelerometric device. The device will be worn for two week periods on repeated occasions to obtain information on activity and sleep behavior in individuals with BBS. Activity and sleep data will be correlated with health information currently collected in CRIBBS. Information gathered in this research is anticipated to promote understanding of energy metabolism and inform design of lifestyle interventions to treat obesity in the BBS population.

MC - Chippewa Falls Center

2655 CTY HWY I

CHIPPEWA FALLS, WI 54729

MC - Wausau Center

2727 PLAZA DRIVE

WAUSAU, WI 54401

MC - Wisconsin Rapids Center

220 24TH ST SOUTH

WISCONSIN RAPIDS, WI 54494

MMC - Ladysmith

906 College Ave W

Ladysmith, WI 54848

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI 54449

MMC - Minocqua

9576 Highway 70

MINOCQUA, WI 54548

MMC - Rice Lake

1700 W STOUT ST

RICE LAKE, WI 54868

MMC - Weston

3400 Ministry Parkway

WESTON, WI 54476

zzzMarshfield Clinic Cancer Care At St Michaels

900 ILLINOIS AVE

STEVENS POINT, WI 54481

zzzMfld Clinic Cancer Care at Sacred Heart Hospita

900 W CLAIREMONT AVE

EAU CLAIRE, WI 54701

This randomized phase II clinical trial studies how well nivolumab after combined modality therapy works in treating patients with high risk stage II-IIIB anal cancer. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.

MC - Wausau Center

2727 PLAZA DRIVE

WAUSAU, WI 54401

MMC - Eau Claire

2310 Craig Rd

Eau Claire, WI 54701

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI 54449

MMC - Minocqua

9576 Highway 70

MINOCQUA, WI 54548

MMC - Rice Lake

1700 W STOUT ST

RICE LAKE, WI 54868

MMC - River Region at Stevens Point

4100 State Highway 66

Stevens Point, WI 54482

MMC - Weston

3400 Ministry Parkway

WESTON, WI 54476

Abstract

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI 54449

MMC - Minocqua

9576 Highway 70

MINOCQUA, WI 54548

MMC - Rice Lake

1700 W STOUT ST

RICE LAKE, WI 54868

MMC - Weston

3400 Ministry Parkway

WESTON, WI 54476

zzzDiagnostic & Treatment Center

3401 CRANBERRY BLVD

WESTON, WI 54476

zzzMarshfield Clinic Cancer Care At St Michaels

900 ILLINOIS AVE

STEVENS POINT, WI 54481

zzzMarshfield Medical Center

611 Saint Joseph Ave

Marshfield, WI 54449

zzzMfld Clinic Cancer Care at Sacred Heart Hospita

900 W CLAIREMONT AVE

EAU CLAIRE, WI 54701

zzzSacred Heart Hospital (Eau Claire)

900 W Clairemont Ave

Eau Claire, WI 54701

Evaluate the structure preservation rate for patients with locally advanced resectable NPNSCC with or without neoadjuvant therapy; all patients will undergo surgical resection and postoperative standard care.

MC - Wausau Center

2727 PLAZA DRIVE

WAUSAU, WI 54401

MMC - Eau Claire

2310 Craig Rd

Eau Claire, WI 54701

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI 54449

MMC - Minocqua

9576 Highway 70

MINOCQUA, WI 54548

MMC - Rice Lake

1700 W STOUT ST

RICE LAKE, WI 54868

MMC - River Region at Stevens Point

4100 State Highway 66

Stevens Point, WI 54482

MMC - Weston

3400 Ministry Parkway

WESTON, WI 54476

zzzDiagnostic & Treatment Center

3401 CRANBERRY BLVD

WESTON, WI 54476

1703: Graft-versus-Host Disease (GVHD) is a complication that affects many hematopoietic stem cell transplant (HSCT) patients; it occurs when the new cells from a transplant attack the recipient's body. The current standard GVHD prophylaxis regimen for patients with hematologic malignancies undergoing HSCT involves a combination of immunosuppressive agents given for the first 6 months after transplant. The standard strategy of Tacrolimus/Methotrexate will be used as a control arm in comparison to one other treatment plan utilizing Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide. Study participants will receive an infusion of mobilized peripheral blood stem cell grafts on both arms. Study participants will be randomized to one of these two treatment arms. 1801: A relationship between the intestinal microbiota and graft-versus-host disease (GVHD) has long been appreciated but is still not well understood. Mice transplanted in germ-free conditions or treated with gut-decontaminating antibiotics developed less severe GVHD. Clinical studies initially suggested a benefit from near-total bacterial decontamination, but later showed no clear benefit and this approach was discontinued in the early 1990s. Partial gut decontamination continues to be practiced at many centers. More recently, the advent of next-generation sequencing (NGS) has resulted in cheaper and easier characterization of complex microbial mixtures. This has led to a renewed interest in evaluating the relationship between the microbiota and human health and disease, including recipients of hematopoietic cell transplantation (HCT). Similarly, NGS has also contributed to significant advancements in the investigator's understanding of immune reconstitution in HCT patients and how this may impact clinica outcomes. The goal of this protocol is to test the primary hypothesis that the engraftment stool microbiome diversity predicts one-year non-relapse mortality in patients undergoing reduced intensity allogeneic HCT.

MC - Chippewa Falls Center

2655 CTY HWY I

CHIPPEWA FALLS, WI 54729

MC - Wausau Center

2727 PLAZA DRIVE

WAUSAU, WI 54401

MMC - Eau Claire Cancer Center

2200 Craig Road

Eau Claire, WI 54701

MMC - Ladysmith

906 College Ave W

Ladysmith, WI 54848

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI 54449

MMC - Minocqua

9576 Highway 70

MINOCQUA, WI 54548

MMC - Rice Lake

1700 W STOUT ST

RICE LAKE, WI 54868

MMC - River Region at Stevens Point

4100 State Highway 66

Stevens Point, WI 54482

MMC - Weston

3400 Ministry Parkway

WESTON, WI 54476

zzzMarshfield Medical Center

611 Saint Joseph Ave

Marshfield, WI 54449

PRIMARY OBJECTIVES: I. To compare the proportions of participants in the tomosynthesis mammography (TM) and digital mammography (DM) study arms experiencing the occurrence of an ?advanced? breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen (T4). SECONDARY OBJECTIVES: I. To assess the potential effect of age, menopausal and hormonal status, breast density, and family cancer history on the primary endpoint difference between the two arms. II. To compare the diagnostic performance of TM and DM, as measured by the area under the receiver operating characteristic (ROC) curve (AUC), sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). III. To compare the recall rates and biopsy rates for TM versus DM, with subset analyses by the same variables as listed in aim II. IV. To compare the rate of interval cancers for TM and DM and to assess the mechanism of diagnosis for these interval cancers with categorization by symptomatic versus (vs) asymptomatic, and how detected: diagnosed via physical examination, mammography, ultrasound (US), magnetic resonance imaging (MRI) or other technologies. V. To examine the correlation between Breast Imaging Reporting and Data System (BIRADS) imaging features and histologic and genetic features, such as invasive ductal and invasive lobular histology, high grade, high stage at diagnosis, and aggressive genetic subtypes. VI. To assess different combinations of TM and synthesized 2 dimensional (2D) or DM in reader studies to assist in determining the optimum balance between diagnostic performance, radiation exposure and technique. VII. To estimate and compare breast-cancer-specific mortality between the two study arms. VIII. To estimate and compare the prevalence of breast cancer subtypes (luminal A, luminal B, HER2+, basal-like) low, medium or high proliferation via PAM50 proliferation signatures, and p53 mutant-like or wild-type-like according to a validated p53 dependent signature in the two arms, overall and stratified on whether cancers were detected through screening or as interval cancers, and whether cancers were invasive or in situ. IX. To classify histologically malignant (true positive cases) and benign lesions (false positive cases) as normal-like or tumor-like using the PAM50 gene expression assay subtype (luminal A, luminal B, HER2, basal-like,), and low, medium, or high proliferation according to PAM50 proliferation signatures, and p53 mutant-like or wild-type-like according to a validated p53-dependent signature. X. To assess the agreement between local and expert study pathologists for all breast lesions (benign and malignant) biopsied during the 4.5 years of screening with TM or DM. XI. To create a blood and buccal cell biobank for future biomarker and genetic testing. XII. To compare health care utilization (including cancer care received) and cost of an episode of breast cancer screening by TM versus DM, overall and within subsets. XIII. To implement a centralized quality control (QC) monitoring program for both 2D digital mammography (DM) and tomosynthesis (TM), which provides rapid feedback on image quality, using quantitative tools, taking advantage of the automated analysis of digital images. XIV. To assess temporal and site-to site variations in image quality, breast radiation dose, and other quality control parameters in TM vs. DM. XV. To refine and implement task-based measures of image quality to assess the effects of technical parameters, including machine type, and detector spatial and contrast resolution on measures of diagnostic accuracy for TM. XVI. To evaluate which QC tests are useful for determination of image quality and those that are predictive of device failure, in order to recommend an optimal QC program for TM. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients undergo bilateral screening DM with standard craniocaudal (CC) and mediolateral oblique (MLO) views at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal. ARM B: Patients undergo manufacturer-defined screening TM at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal. After completion of study, patients are followed up for at least 3- 8 years after study entry.

MC - Chippewa Falls Center

2655 CTY HWY I

CHIPPEWA FALLS, WI 54729

MC - Wausau Center

2727 PLAZA DRIVE

WAUSAU, WI 54401

MC - Wisconsin Rapids Center

220 24TH ST SOUTH

WISCONSIN RAPIDS, WI 54494

MMC - Ladysmith

906 College Ave W

Ladysmith, WI 54848

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI 54449

MMC - Minocqua

9576 Highway 70

MINOCQUA, WI 54548

MMC - Rice Lake

1700 W STOUT ST

RICE LAKE, WI 54868

MMC - Weston

3400 Ministry Parkway

WESTON, WI 54476

zzzMarshfield Clinic Cancer Care At St Michaels

900 ILLINOIS AVE

STEVENS POINT, WI 54481

zzzMfld Clinic Cancer Care at Sacred Heart Hospita

900 W CLAIREMONT AVE

EAU CLAIRE, WI 54701

This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

MC - Chippewa Falls Center

2655 CTY HWY I

CHIPPEWA FALLS, WI 54729

MC - Wausau Center

2727 PLAZA DRIVE

WAUSAU, WI 54401

MC - Wisconsin Rapids Center

220 24TH ST SOUTH

WISCONSIN RAPIDS, WI 54494

MMC - Eau Claire

2310 Craig Rd

Eau Claire, WI 54701

MMC - Ladysmith

906 College Ave W

Ladysmith, WI 54848

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI 54449

MMC - Minocqua

9576 Highway 70

MINOCQUA, WI 54548

MMC - Rice Lake

1700 W STOUT ST

RICE LAKE, WI 54868

MMC - River Region at Stevens Point

4100 State Highway 66

Stevens Point, WI 54482

MMC - Weston

3400 Ministry Parkway

WESTON, WI 54476

This phase III trial studies how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

MC - Chippewa Falls Center

2655 CTY HWY I

CHIPPEWA FALLS, WI 54729

MC - Wausau Center

2727 PLAZA DRIVE

WAUSAU, WI 54401

MC - Wisconsin Rapids Center

220 24TH ST SOUTH

WISCONSIN RAPIDS, WI 54494

MMC - Ladysmith

906 College Ave W

Ladysmith, WI 54848

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI 54449

MMC - Minocqua

9576 Highway 70

MINOCQUA, WI 54548

MMC - Rice Lake

1700 W STOUT ST

RICE LAKE, WI 54868

MMC - Weston

3400 Ministry Parkway

WESTON, WI 54476

zzzLakeview Medical Center

1700 West Stout Street

Rice Lake, WI 54868

zzzMarshfield Clinic At James Beck Cancer Center

2251 NORTH SHORE DR

RHINELANDER, WI 54501

zzzMarshfield Clinic Cancer Care At St Michaels

900 ILLINOIS AVE

STEVENS POINT, WI 54481

zzzMfld Clinic Cancer Care at Sacred Heart Hospita

900 W CLAIREMONT AVE

EAU CLAIRE, WI 54701

This phase III trial studies how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI 54449

MMC - River Region at Stevens Point

4100 State Highway 66

Stevens Point, WI 54482

MMC - Weston

3400 Ministry Parkway

WESTON, WI 54476

zzzDiagnostic & Treatment Center

3401 CRANBERRY BLVD

WESTON, WI 54476

The purpose of this study is to learn about the safety of RBX2660 and whether it is effective in preventing recurrent Clostridium difficile infection (CDI).

MC - Wausau Center

2727 PLAZA DRIVE

WAUSAU, WI 54401

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI 54449

MMC - Minocqua

9576 Highway 70

MINOCQUA, WI 54548

MMC - Rice Lake

1700 W STOUT ST

RICE LAKE, WI 54868

MMC - River Region at Stevens Point

4100 State Highway 66

Stevens Point, WI 54482

MMC - Weston

3400 Ministry Parkway

WESTON, WI 54476

zzzMfld Clinic Cancer Care at Sacred Heart Hospita

900 W CLAIREMONT AVE

EAU CLAIRE, WI 54701