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The multi-site cohort and approach will clarify the role of NICU-based phthalate exposure on high-prevalence clinical outcomes. Cranial radiation therapy RT , commonly used to treat benign and malignant brain tumors, can lead to cognitive impairments in domains not related to neuroanatomic structures directly impacted by the tumor. The study will prospectively enroll 58 patients with benign and low-grade brain tumors who will undergo partial brain RT, with either conventionally fractionated or hypofractionated schedules.
Subjects will receive MRI scans at baseline and 6 months. Given the role of the limbic system in key cognitive functions affected by RT, researchers have a particular interest in characterizing MRI changes in the limbic system and thalamus in relation to memory and related processes.
Specific Aims: To examine objective neurocognitive changes over time. To examine changes in brain tissue via MRI induced by off-target RT in patients with benign and low-grade brain tumors. The investigators specifically hypothesize that comapping of RT dose and MRI changes in the thalamus and limbic system i. To examine the relationship between MRI changes for key neuroanatomic structures identified in Aim 1 with objective neurocognitive testing. The investigators hypothesize that cognitive decline will be correlated with damage revealed by MRI to limbic and thalamic structures.
This research will help to define which neuroanatomic structures are most at risk from RT-induced damage and will help ultimately establish new dose constraint guidelines for important structures to improve cognitive outcomes. This study's goal is to find out if the kind of side effects people experience from radiation is different depending on the schedule of their radiation treatment.
Patients will be randomly assigned to either the 3 Fraction or 5 Fraction schedule of radiation. After patients complete radiation treatment, they will follow up with their radiation oncologist.
The purpose of the study is to study dry mouth as the frequent side effect of certain medications. Dry mouth can lead to tooth decay and cavities, damage to the gums of your mouth, and problems with speaking and swallowing. There is not a lot known about how certain medications can affect oral health. This study will explore how genetic variations and certain medications play a role in the development of dry mouth.
Inclusion criteria: age between 45 and 64 years; usage of at least one medication that could cause dry mouth.
Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery.
A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy might be more effective in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery.
This phase II trial studies how well lower-dose chemotherapy plus radiation chemoradiation therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, 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.
Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells.
This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type. This study will further assess electroretinogram ERG components obtained with different ERG devices, to be considered in a prediction model for each diagnosis. The prediction models are diaMentis proprietary software used as an ERG-based diagnostic test classified as a Software as a Medical Device, SaMD to support the diagnosis of schizophrenia and bipolar disorder type I.
They involve the processing and analysis of specific retinal biosignatures RSPA with the support of statistical and mathematical modelling processes e. The purpose of this study is to validate and refine a technology that can help physicians determine whether an abnormal pelvic mass in women is benign non-cancerous or malignant cancerous using a blood test.
The specific technology is called ParsortixTM PC1 system, a semi-automated system capable of capturing and harvesting rare cells for subsequent analysis from blood based on the size and deformability of the cells. This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with total intravenous anesthesia using propofol versus volatile agent sevoflurane, isoflurane, or desflurane during cancer surgery.
The primary endpoint is all-cause mortality. The purpose of this study is to better understand the sensitivity of listeners to the fast changes in frequency or amplitude of sounds that occur in speech. The investigators are studying ways to manipulate these aspects of sounds in an effort to make speech sounds more clear.
We are recruiting listeners with either normal hearing or hearing loss. All listeners will have their hearing tested at the beginning of the study. The purpose of this study is to document and evaluate all problems that may occur with the use of investigational cord blood units. This study will evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems.
The Hydrocortisone and Extubation study will test if giving hydrocortisone for 10 days improves survival for premature infants who have a breathing tube. Infants will either receive hydrocortisone or placebo. The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.
The study will investigate if pelareorep in combination with paclitaxel and avelumab is more effective than paclitaxel alone, or pelareorep and paclitaxel. The safety of the combination treatments will also be evaluated. The reason for this study is to see if the study drug LY alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.
This is an event driven, adaptive design, a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 3 study of DSP Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with recurrent or progressive glioblastoma multiforme GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.
NuTide compares NUC with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer. The primary hypotheses are: The combination of NUC plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care The combination of NUC plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care.
A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About subjects will be randomized in a ratio to receive either crenolanib in addition to standard first line treatment of AML chemotherapy and if eligible, transplantation arm A or midostaurin and standard treatment arm B.
Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.
Eligible untreated patients with FLT3 acute myeloid leukemia AML between the ages of 18 and 70 will be randomized to receive gilteritinib or midostaurin during induction and consolidation.
Patients will also receive standard chemotherapy of daunorubicin and cytarabine during induction and high-dose cytarabine during consolidation. Gilteritinib, is an oral drug that works by stopping the leukemia cells from making the FLT3 protein. This may help stop the leukemia cells from growing faster and thus may help make chemotherapy more effective.
Midostaurin is an oral drug that works by blocking several proteins on cancer cells, including FLT3 that can help leukemia cells grow. Blocking this pathway can cause death to the leukemic cells.
The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving combination chemotherapy for FLT3 AML. This is a phase 3, open-label, 3-cohort, randomized study to compare the safety and efficacy of N in combination with the current standard of care experimental arms versus standard of care alone control arms , as first-line treatment for subjects with stage 3 or 4 advanced or metastatic NSCLC.
Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the investigator feels that it is no longer in the patient's best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months after the first dose of study drug.
UV1 is a therapeutic cancer vaccine that has been explored in prostate, lung cancer, in combination with ipilimumab in malignant melanoma and in combination with pembrolizumab in metastatic melanoma. The study will have several parts. It will also find out how safe the treatment is and how well it works. Dexamethasone and pomalidomide are both drugs that can be used to treat multiple myeloma. These parts of the study will find out whether these drugs are safe when used together.
AL or light chain amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract.
The purpose of this study is to evaluate the efficacy of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose s RP2Ds Part 3. This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy narrowing of the large intestine.
Patients will be followed at their regular clinical care visits over a year period and approached if they develop symptoms of fibrosing colonopathy for collection and use of further detailed information. This research is being done because we hope that a better understanding of hematologic malignancies will allow us to develop new and better treatments.
Patent ductus arteriosus PDA is an extra blood vessel found in babies before birth and just after birth. In most babies who have an otherwise normal heart, the PDA will shrink and close on its own in the first few days of life. If it stays open longer, it may cause extra blood to flow to the lungs. This study estimates the risks and benefits of active treatment versus expectant management of premature babies with patent ductus arteriosus.
Apnea of prematurity AOP is a condition in which premature infants stop breathing for 15 to 20 seconds during sleep. The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization. The purpose of this study is to collect clinical data along with bone marrow aspirate samples to see if there is a way to determine which patients are more or less likely to experience disease progression.
This study will involve identifying different markers on the surfaces of the plasma cells and will look at protein expression. We will then correlate those findings with data from your medical records over time.
If you decide to take part in this study, you will be asked to allow additional bone marrow aspirate and blood samples to be collected for research at several time points.
These additional samples will be collected during routine testing time points as required for your routine care. We will also collect information about your disease and treatment from your medical record.
The questionnaire will take about 10 minutes to complete; study staff will remain available to assist you. Myotonic dystrophy DM and facioscapulohumeral muscular dystrophy FSHD are inherited disorders characterized by progressive muscle weakness and loss of muscle tissue. The registry will offer individuals with DM and FSHD an opportunity to participate in research that focuses of their diseases.
The registry will also help scientists to accomplish research on DM and FSHD and to distribute their findings to patients and care providers.
This randomized phase III trial studies how well stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer.
Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Stereotactic body radiation therapy may work better in treating patients with prostate cancer. This phase II trial studies the side effects and best dose of niraparib, and to see how well it works in combination with standard of care radiation therapy and hormonal therapy androgen deprivation therapy in treating patients with prostate cancer that has a high chance of coming back high risk.
Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding niraparib to the usual treatments of radiation therapy and hormonal therapy may lower the chance of prostate cancer growing or returning. This phase III trial studies how well adding apalutamide, abiraterone acetate, and prednisone to the usual hormone therapy and radiation therapy works compared to the usual hormone therapy and radiation therapy in treating patients with node-positive prostate cancer after surgery.
Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or slow the growth of prostate cancer cell growth by blocking the androgens.
Abiraterone acetate blocks some of the enzymes needed for androgen production and may cause the death of prostate cancer cells that need androgens to grow.
Prednisone may help abiraterone acetate work better by making tumor cells more sensitive to the drug. Adding apalutamide and abiraterone acetate with prednisone to the usual usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading or extend time without disease spreading compared to the usual approach.
All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel.
Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel 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. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
Chemotherapy drugs, such as 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 trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, 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.
Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone.
This randomized clinical trial seeks to determine if osteopathic manipulative medicine OMM increases the likelihood of improved neurodevelopmental outcomes as estimated by the Test of Infant Motor Performance TIMP. We will establish two prospective groups of patients with Acute Lymphoclastic Leukemia ALL : "Cohort A" will be enrolled on the study at the time of diagnosis while "Cohort B" will be enrolled during maintenance chemotherapy. This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma.
Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. This phase III trial studies iobenguane I or crizotinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I, may carry radiation directly to tumor cells and not harm normal cells.
Crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I or crizotinib and standard therapy may work better compared to crizotinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma. This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma.
Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is.
The pandemic accelerated the shift to remote clinical studies, as researchers were essentially forced to rethink how to conduct ongoing studies and design new ones.
However, the concept is still novel. Despite being conducted from Rochester, all three studies recruited from a broad geographic area, with participants from between 34 and 40 states, territories, and Canadian provinces in each study. At the same time, the pandemic also exposed the digital divide and the need to invest in affordable high speed internet in many areas of the country.
In Kevin Walter, M. She had additional chemotherapy and missed as little work as possible. After a long remission, the cancer returned in , which required a second surgery. Her oncology team, led by Nimish Mohile, M. She was a bit unsure at first but decided to enroll after learning that the costs of treatment, blood work, and MRIs would be covered by the company sponsoring the trial.
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