Harbor Springs

Researchers are investigating whether adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy using the TheraBionic P1 device can affect the pathological response in patients with resectable early-stage breast cancer. This study focuses on women with hormone receptor-positive, HER2-negative breast cancer who are planning upfront surgery. The research is designed to evaluate the treatments impact before surgery in a neoadjuvant setting. Participants will self-administer the TheraBionic P1 device therapy three times a day for 60 minutes each sessionmorning, midday, and eveningover approximately two weeks before their scheduled tumor resection surgery. This device delivers amplitude-modulated electromagnetic fields continuously during these sessions. The study does not include a comparison group or blinding. During the trial, participants will have their tumor tissue evaluated for pathological response at the time of surgery. Researchers will also analyze changes in microRNA, Ki-67, tumor apoptosis marker Cleaved caspase-3, and cell cycle arrest marker p27 from baseline to post-surgical tissue. Long-term follow-up will assess overall survival and progression-free survival for up to five years after surgery. Participants will be monitored for safety and treatment adherence throughout the study period.

Researchers are evaluating the combination of amplitude-modulated radiofrequency electromagnetic fields AM RF EMF and Fruquintinib in adults with metastatic colorectal adenocarcinoma that has not responded to standard treatments. This Phase 2 study aims to determine if adding AM RF EMF to Fruquintinib improves survival while being safe and tolerable. The trial focuses on patients whose cancer has progressed despite previous therapies targeting RAS, BRAF, MSIMMR, and HER2 markers. Participants receive treatment with the TheraBionic P1 device delivering AM RF EMF three times daily continuously, alongside daily doses of Fruquintinib taken orally in cycles of three weeks on treatment followed by one week off. This combined therapy is studied throughout the treatment period, with careful monitoring of safety and tolerability. Throughout the study, participants undergo regular assessments including imaging scans CT, MRI, or PET to evaluate disease status, and blood tests to measure biomarkers like carcinoembryonic antigen CEA and microRNA levels. Researchers will track overall survival up to five years post-treatment or until death. Safety is monitored during treatment and for 28 days after device discontinuation. The total participation duration varies as outcomes are followed long term.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are evaluating the Ask Questions about Clinical Trials ASQ-CT brochure, a communication tool designed to improve conversations between patients and healthcare providers about clinical trials. This trial focuses on patient-provider communication and provider invitations to clinical trials among adults with oncology, cardiac disease, or neurologic disorders who are potentially eligible for clinical trials. The study is conducted by the Barbara Ann Karmanos Cancer Institute and is a health services research trial. Participants receive the ASQ-CT brochure at the baseline visit Time 1 as the main intervention. They complete questionnaires at three timepoints baseline Time 1, before their research visit Time 2, and after their research visit Time 3. The brochure serves as a question prompt list aimed at facilitating communication about clinical trials. Throughout the study, participants answer surveys that measure their confidence in managing patient-provider interactions, knowledge about clinical trials, trust, and distress levels at different timepoints. The researchers also track how many participants engage with the brochure and how well the intervention is implemented over up to three months. The total participation duration spans from the initial baseline questionnaire to the post-research visit follow-up.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are investigating whether adding the drug Docetaxel to the usual hormone treatments, Androgen Deprivation Therapy ADT and Androgen-Receptor Pathway Inhibitor ARPI, can better control metastatic castration sensitive prostate cancer in men who have not responded optimally to initial hormone therapy. This phase III, international, open-label, randomized trial seeks to compare the effectiveness of this combined approach against the standard hormone therapy alone. Participants will be randomly assigned to receive either the standard hormone therapy with ADT plus ARPI or the same hormone therapy combined with Docetaxel chemotherapy. The trial focuses on men with metastatic prostate cancer who continue to have elevated PSA levels after 6 to 12 months of hormone-targeting treatment. Treatments are administered according to physician choice and assignment, and the study evaluates outcomes over a long period. During the trial, participants will be closely monitored with assessments including PSA levels and clinical progression over 39 months. Researchers will measure overall survival as the primary outcome, along with secondary outcomes such as PSA progression, PSA response, PSA kinetics, and progression-free survival. Participants must be accessible for treatment and follow-up to allow for complete documentation of treatment effects and adverse events throughout the study duration.

Researchers are evaluating the effect of dalcetrapib on cardiovascular risk in people recently hospitalized for acute coronary syndrome ACS who have a specific genetic profile AA genotype. This phase 3, randomized, double-blind, placebo-controlled study focuses on adults aged 45 years and older, aiming to assess the time to first occurrence of fatal or non-fatal myocardial infarction over an average of 30 months from randomization. The study will continue until around 200 participants experience a primary event, or until stopped at an interim analysis. Participants will be randomly assigned to receive either dalcetrapib 600 mg daily, two 300 mg tablets or matching placebo tablets once daily. Screening includes genetic testing for the AA genotype using a specialized Genotype Assay Test. Enrollment can begin during hospitalization or after discharge, but randomization must occur within 12 weeks of the ACS event. After randomization, follow-up visits will be virtual when possible or in clinic every three months until the study ends. Assessments will continue every three months for participants who stop the study medication early. Participants will undergo medical history review and genetic testing before enrollment. During the study, researchers will monitor cardiovascular events such as heart attacks and strokes through regular assessments every three months. Safety evaluations and collection of study endpoints will continue for the duration of participation, which may last approximately 30 months or until the study stops. This includes ongoing monitoring for adverse effects and overall health status.

Researchers are studying premenopausal women with early-stage breast cancer that is estrogen receptor-positive and HER2-negative, focusing on tumors with specific gene recurrence scores. The trial aims to find out if adding chemotherapy to ovarian function suppression plus endocrine therapy improves invasive breast cancer-free survival compared to ovarian function suppression plus endocrine therapy alone. This Phase III trial addresses the need for better treatments in younger women, given their higher risk and past conflicting study results on ovarian suppression and chemotherapy. Participants are randomly assigned to one of two groups one receiving ovarian function suppression combined with an aromatase inhibitor for five years, and the other receiving adjuvant chemotherapy followed by the same ovarian function suppression and aromatase inhibitor regimen. Choices for the aromatase inhibitor and gonadotropin releasing hormone agonist are made by the investigator, with options including drugs such as goserelin, leuprolide, or triptorelin. Endocrine treatment beyond five years is at the investigators discretion, and bilateral oophorectomy may be used instead of ovarian suppression if preferred. During the study, participants are monitored over 11 years from randomization, with measurements including invasive breast cancer-free survival as the primary outcome. Secondary outcomes include disease-free survival, overall survival, recurrence intervals, menopausal symptoms, and pain during aromatase inhibitor therapy. Safety and treatment effects are assessed through regular evaluations, and participants continue to be followed long term to understand the impact of treatments on their breast cancer outcomes.

Researchers are evaluating the combination of nab-paclitaxel, gemcitabine, and an Amplitude-Modulated Radiofrequency Electromagnetic Fields device called TheraBionic P1 for patients with metastatic pancreatic adenocarcinoma. This Phase 2 trial aims to find out if this combined treatment is safe and effective for this advanced cancer. Participants will receive standard chemotherapy with nab-paclitaxel and gemcitabine administered weekly in specific doses through infusions. Alongside chemotherapy, the TheraBionic P1 device delivers low-level radio waves into the body via a spoon-shaped antenna placed in the mouth three times daily for one hour each session. This treatment plan continues as scheduled during the study. Throughout the study, participants will have multiple assessments including imaging scans to measure tumor response and progression. Researchers will monitor progression-free survival at 6 months as the primary outcome, along with other measures such as overall survival, adverse events, and disease control over up to one year. Participants will be closely observed for safety and treatment effects during the study period, which runs until July 2027.