Port Huron

Researchers are evaluating if adding a special device called the TheraBionic P1, which uses amplitude-modulated radiofrequency electromagnetic fields, can impact the treatment response in women with early-stage, operable breast cancer that is hormone receptor positive and HER2-negative. This pilot study focuses on patients scheduled for surgery and aims to understand how this device affects the cancer before removal. Participants will use the TheraBionic P1 device by self-administering three 60-minute treatments each day—morning, midday, and evening—continuously for about two weeks before their planned surgery to remove the tumor. The device delivers specific electromagnetic fields targeting the cancer during this pre-surgical period. During the study, participants will be closely monitored, and their pathological response to the treatment will be assessed at the time of surgery, approximately two weeks after starting the device therapy. Researchers will review tissue samples and track safety measures while ensuring participants follow the treatment and study protocols. This involvement lasts from treatment initiation through surgery and includes follow-up monitoring for adherence and safety.

Researchers are evaluating the effectiveness of active surveillance and chemotherapy treatments in pediatric, adolescent, and adult patients with low risk and standard risk germ cell tumors. This phase III trial focuses on monitoring patients after tumor removal and comparing the outcomes of carboplatin-based versus cisplatin-based chemotherapy regimens. The study aims to maintain high overall survival rates for low risk patients and to compare event-free survival between the two chemotherapy options in standard risk patients. Additional objectives include assessing side effects such as hearing loss and neuropathy, and exploring tumor marker changes and other biological measures related to treatment outcomes. Patients with low risk stage I germ cell tumors undergo surgery followed by observation, with the option to transfer to standard risk treatment if the tumor recurs. Those with standard risk tumors are randomly assigned to one of four chemotherapy regimens combining bleomycin, etoposide, carboplatin, or cisplatin. Treatments are given intravenously on specific schedules every 21 days for up to 3 or 4 cycles, depending on the group. Throughout the trial, patients receive imaging scans, blood tests, tumor biopsies if needed, and pulmonary function tests to monitor treatment response and side effects. Participants are closely followed after treatment completion with regular visits every 2 months for the first year, then less frequently up to 10 years. Researchers collect data through imaging, blood samples, lung tests, and questionnaires to measure survival, disease recurrence, and side effects like hearing loss. The study also includes exploratory analyses of tumor markers and patient-reported outcomes to better understand treatment impacts and improve future care for germ cell tumor patients.

Researchers are evaluating if adding amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) to the drug Fruquintinib can improve survival and be safe for patients with metastatic colorectal cancer that no longer responds to standard treatments. This phase 2 study focuses on people with confirmed metastatic colorectal adenocarcinoma who have previously received specific chemotherapy and targeted therapies but whose cancer has progressed or who cannot tolerate those treatments. Participants receive Fruquintinib, a drug that targets certain blood vessel receptors involved in cancer growth, combined with the TheraBionic P1 device, which delivers AM RF EMF. The study tests this combination's effects on survival and tolerance. Treatment monitoring includes regular imaging scans such as CT, MRI, or PET to evaluate disease status. During the study, participants are closely monitored for overall survival up to five years after treatment ends or until death. Researchers assess safety, organ function, and cancer progression through scans and clinical evaluations. Participants must be able to take oral medication and use the device, and they are followed according to the study protocol for the entire duration of the trial.

Researchers are evaluating comprehensive genomic analysis in tissue samples from patients with recurrent or stage IV non-small cell lung cancer. This analysis aims to identify specific gene mutations in the cancer's DNA, which may help doctors tailor treatments to target these mutations more precisely. The study seeks to determine how often therapy can be started based on these genomic test results and to understand the outcomes for patients who receive such targeted therapy. Patients provide tumor tissue samples for genomic analysis using techniques like mass spectrometry, polymerase chain reaction (PCR), and microarray. Those whose genomic results indicate suitable targets may begin therapy tailored to their tumor's specific mutations. The study involves collecting and analyzing existing tumor samples or performing new biopsies if needed. During the study, patients undergo laboratory tests and tissue collection, followed by therapy initiation when appropriate. After treatment, patients are monitored every 3 months for 2 years, then every 6 months for 3 years, and annually thereafter to track progression-free survival and response to therapy. The main outcome measured is the proportion of patients who start treatment based on genomic analysis within 21 days. Safety and long-term outcomes are also followed.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are evaluating the safety and effectiveness of a combination treatment for patients with metastatic pancreatic adenocarcinoma. This Phase 2 study investigates the use of gemcitabine, nab-paclitaxel, and the TheraBionic P1 device, which delivers amplitude-modulated radiofrequency electromagnetic fields, to see if this approach can help control the disease. The treatment involves giving patients nab-paclitaxel as a 30-40 minute infusion weekly on days 1, 8, and 15 or on days 1 and 15. Following this, gemcitabine is administered over 30 minutes on the same schedule. In addition, patients use the TheraBionic P1 device, which applies low-level radio waves through an antenna placed in the mouth three times daily for one hour each time. Participants will be closely monitored throughout the study. This includes imaging scans like CT, MRI, or PET to measure tumor response, laboratory tests to check blood counts and organ function, and assessments of overall health and side effects. The main outcome measured is the progression-free survival rate at six months. Patients are followed to assess safety, treatment effects, and to understand how well they tolerate the combination therapy.

Researchers are investigating treatments for patients with high-risk smoldering multiple myeloma in this phase III trial. The study compares the effects of lenalidomide and dexamethasone given with or without daratumumab. These drugs work in different ways to stop tumor growth, and the combination with daratumumab, an immunotherapy, may better interfere with tumor cell growth and spread. The trial aims to assess overall survival, progression-free survival, treatment safety, and quality of life among participants. Participants are randomly assigned to one of two treatment groups. One group receives daratumumab intravenously on specific days across up to 24 cycles, combined with daily oral lenalidomide for 21 days and oral dexamethasone on days 1, 8, 15, and 22 for 12 cycles. The other group receives only lenalidomide and dexamethasone on the same schedule for up to 24 cycles. Treatment continues every 28 days until disease progression or unacceptable side effects occur. During the study, participants undergo regular assessments including blood tests, bone marrow biopsies, imaging scans, and patient questionnaires to monitor treatment effects and quality of life. Researchers track overall survival for up to 15 years, evaluate minimal residual disease, and monitor medication adherence and adverse events. Follow-up visits occur every 3, 6, or 12 months after treatment ends to continue monitoring health outcomes.

Researchers are evaluating two chemotherapy treatments, mFOLFIRINOX and mFOLFOX, with or without the immunotherapy drug nivolumab, for advanced, unresectable, or metastatic HER2 negative adenocarcinoma of the esophagus, gastroesophageal junction, and stomach. This phase III trial aims to determine whether adding irinotecan to the usual FOLFOX regimen improves overall survival and other outcomes such as progression-free survival, response rates, and treatment tolerability. The study also explores biomarkers like PD-L1 combined positive score and cell free DNA to understand treatment effects better. Participants are randomly assigned to one of two treatment groups. One group receives fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with nivolumab as needed, while the other group receives fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with nivolumab as needed. All drugs are given intravenously. Throughout the trial, patients undergo MRI and CT scans and may provide blood samples for additional testing. During the study, participants are closely monitored for overall survival for up to two years after randomization. Researchers assess safety, side effects, and patient-reported outcomes to evaluate treatment tolerability. The trial also tracks progression of disease and response to therapy using imaging and other clinical evaluations. Participation includes regular imaging, blood collection, and completing questionnaires to help understand the impact of these treatments.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.