Feature Channels: Clinical Trials

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A drug approved to treat breast cancer patients with mutations in the BRCA1 or BRCA2 genes may also benefit people who have other genetic mutations.

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Shafali Spurling Jeste, MD, shares early findings—and a critical challenge—from the Autism Biomarkers Consortium for Clinical Trials. How do you know if a treatment for autism is effective? That’s a question that has no easy answer—due in large part to the heterogeneous nature of autism spectrum disorder.

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Cedars-Sinai has been awarded a five-year, $8 million grant from California’s stem cell agency to launch an innovative new clinic that will expand patients’ access to stem cell and gene therapies, increase research and training in regenerative medicine, foster greater collaboration with eight similar clinics across the state and help educate the public about stem cell and related therapies.

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An article published in Science Advances suggests that a type of cancer treatment known as immune checkpoint blockade may be beneficial in certain cases of severe COVID-19.

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UC San Diego will be one of multiple sites assessing the safety and efficacy of tecovirimat as a potential treatment for human monkeypox. Marketed as TPOXX, tecovirimat is an antiviral currently approved for treatment of human smallpox in adults and children caused by the variola virus.

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The American Society of Nephrology (ASN) will hold Kidney Week, the world’s premier kidney meeting, in Orlando, FL, November 3–6, 2022. The results of scientific studies and high-impact clinical trials that will advance kidney-related research and medical care will be presented in-person and online.

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Six Mayo Clinic staff are award recipients in Cohort II of the Robert A. Winn Diversity in Clinical Trials Career Development Award. The two-year program aims to train, develop and mentor diverse and community-oriented researchers and physicians to help increase the diversity of patients enrolled in clinical trials, and ultimately to enhance the development of therapeutics for all populations.

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Free online event for cancer patients and caregivers featuring immunotherapy experts and patient advocates taking place Nov. 11-12, 2022.

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Researchers from The University of Texas MD Anderson Cancer Center demonstrated that adding metastasis-directed radiation therapy to intermittent hormone therapy improved progression-free survival (PFS) in patients with oligometastatic prostate cancer. Findings from the multicenter EXTEND trial were presented today at the 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting.

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A new approach to cancer immunotherapy that uses one type of immune cell to kill another—rather than directly attacking the cancer—provokes a robust anti-tumor immune response that shrinks ovarian, lung, and pancreatic tumors in preclinical disease models, according to researchers at the Icahn School of Medicine at Mount Sinai in New York. The findings were published October 11, 2022 in the journal Cancer Immunology Research [https://doi.org/10.1158/2326-6066.CIR-21-1075]. The study involved a twist on a type of therapy that uses immune cells known as CAR T cells. CAR T cells in current clinical use are engineered to recognize cancer cells directly and have successfully treated several blood cancers. But there have been challenges that prevent their effective use in many solid tumors.

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Researchers at University Hospitals (UH) Seidman Cancer Center in Cleveland, Ohio and a biotech start-up company have developed a streamlined way to manufacture CAR T-cells for immunotherapy treatment in just 24 hours – an improvement over the team’s previous benchmark of eight days and commercial suppliers that typically take three weeks. The team is one of the first in the country to test this manufacturing approach.

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A three-week course of radiation therapy is as safe and effective as four to six weeks of treatment for patients with early-stage breast cancer who have a higher risk of having their tumors recur, results of a randomized phase III clinical trial show. Delivering fewer, but higher, doses of radiation following lumpectomy, while concurrently delivering a radiation boost to the surgical site, led to similar outcomes as a longer course of treatment.

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Adding radiation therapy to systemic therapy for patients with advanced liver cancer can extend overall survival and delay tumor progression without compromising patients’ quality of life, a randomized phase III clinical trial shows.

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In the face of conflicting evidence over the risks and benefits of routine prostate cancer screenings, a large, longitudinal analysis found Veterans Health Administration (VA) medical centers with lower prostate screening rates had higher rates of metastatic prostate cancer cases in subsequent years than centers with higher screening rates.

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Using a novel response-adapted ultra-low dose radiation therapy strategy, MD Anderson researchers observed a 90% complete response rate in patients with orbital indolent B-cell lymphoma. The results were presented today at the 2022 ASTRO Annual Meeting.

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Treating high-risk, asymptomatic bone metastases with radiation may reduce painful complications and hospitalizations and possibly extend overall survival in people whose cancer has spread to multiple sites, a phase II clinical trial suggests. Results of the multicenter, randomized trial (NCT03523351) will be presented today at the American Society for Radiation Oncology (ASTRO) Annual Meeting.

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Meeting with a medical physicist who can explain how radiation therapy is planned and delivered reduces patient anxiety and increases patient satisfaction throughout the treatment process, according to a new study published today in the International Journal of Radiation Oncology • Biology • Physics. Findings of the randomized, prospective phase III clinical trial also will be presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting.

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A new randomized study confirms that men with high-risk prostate cancer can be treated with five versus eight weeks of radiation therapy.

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In a large analysis of over 7,000 men treated internationally across 12 randomized trials, study shows that it is almost universally optimal for men to begin androgen deprivation therapy when starting radiation.

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Women at risk of pregnancy loss who need a specialist surgical procedure could benefit from a single-stranded suture thread to reduce risk of infection, results from the C-STICH clinical trial found.

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The GW School of Medicine and Health Sciences is recruiting participants for the final stage of a clinical trial to evaluate two Omicron-specific vaccines. The study, known as the COVID-19 Variant Immunologic Landscape (COVAIL) trial, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The George Washington University School of Medicine and Health Sciences has received funding support as an agreement under NIH contract number 75N91019D00024 to Leidos Biomedical Research in Frederick, Maryland.

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A new study by researchers at UC Davis Children’s Hospital uses the first randomized controlled trial to evaluate PC-CARE’s effectiveness for children with challenging behaviors and their parents or caregivers. The study’s findings were recently published in the Journal of Child Psychiatry Human Development.

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University of Maryland School of Medicine (UMSOM) researchers opened recruitment this month to assess whether a novel remote therapeutic monitoring system can help people with inflammatory bowel disease (IBD) adhere to their medication regimen, and ultimately improve their symptoms and prevent dangerous flare-ups.

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Approximately 500 healthy volunteers with no history of cancer are being sought to contribute blood cells that may be used in the development of cancer clinical trials.

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Patients who have surgery to repair bone fractures typically receive a type of injectable blood thinner, low-molecular-weight heparin, to prevent life-threatening blood clots, but a new clinical trial found that over-the-counter aspirin is just as effective.

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A device known as a bionic pancreas, which uses next-generation technology to automatically deliver insulin, was more effective at maintaining blood glucose (sugar) levels within normal range than standard-of-care management among people with type 1 diabetes, a new multicenter clinical trial has found.

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As more patients with cancer have their tumors genomically profiled, and more therapies targeting genomic alterations enter clinical trials, the task of connecting patients to trials for which they are eligible can be especially challenging. A computer platform developed at Dana-Farber Cancer Institute makes the matching process both easier and faster, its designers report in a new study.

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Michelle and Jeff were excited to build their new family together, but when she received the distressing news that her developing baby was diagnosed with spina bifida, she looked for the best treatment. She was referred to the world’s first stem cell clinical trial.

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UC San Diego scientists are leading a national early-stage clinical trial to assess the safety and efficacy of using bacteriophages to treat drug-resistant bacterial infections in cystic fibrosis patients.

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Three babies have been born after receiving the world’s first spina bifida treatment combining surgery with stem cells. This was made possible by a landmark clinical trial at UC Davis Health known formally as the “CuRe Trial: Cellular Therapy for In Utero Repair of Myelomeningocele.”

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The Indiana University Melvin and Bren Simon Comprehensive Cancer Center has named Michele Coté, PhD, director of the Susan G. Komen Tissue Bank, the world’s only healthy breast tissue bank.

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Moffitt Cancer Center’s efforts to increase minority accrual to cancer treatment trials got a boost from the National Cancer Institute’s Connecting Underrepresented Populations to Clinical Trials U01 Grants Program. The five-year, $3.7 million grant will help the cancer center develop new digital tools and community outreach strategies to reach Black and Hispanic cancer patients and physicians in the Tampa Bay community.

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The National Institutes of Health's National Institute on Aging (NIA) recently awarded researchers from Indiana University's School of Public Health-Bloomington and School of Medicine $3.96 million to fund a five-year, randomized clinical trial of an Alzheimer’s disease and related dementia (ADRD) telehealth intervention.

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The American Society for Radiation Oncology (ASTRO) announced today the 10 studies that will be highlighted in the 2022 ASTRO Annual Meeting press program. Researchers will discuss their findings in two news briefings to be held October 24 and 25 in the Henry B. Gonzalez Convention Center in San Antonio and via live webcast. Reporters can register for the meeting at astro.org/annualmeetingpress.

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Cleveland: Findings from a Cleveland Clinic-led trial show that increasing the salt intake by mouth for patients who are hospitalized with heart failure undergoing aggressive diuretic therapy did not affect how much fluid they retain or their kidney function, indicating that salt intake for heart failure patients may not be as harmful as previously thought. Conversely, these new findings may challenge the common practice of salt restriction during hospital admission since that might not be as helpful.

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Researchers are working to improve outcomes for Black women with breast cancer, the most commonly diagnosed cancer and leading cause of cancer death in this population, according to the American Cancer Society. Coral Omene, MD, PhD, medical oncologist at the Stacy Goldstein Breast Cancer Center and member of the Cancer Health Equity Center of Excellence at Rutgers Cancer Institute shares more on increased participation in clinical trials, which helps find better ways to prevent, diagnose and treat cancer, diversity in breast cancer research, and what Black women need to know.

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A new study led by Cedars-Sinai investigators found using breath tests to identify gut gas profiles can potentially help lead to more personalized therapies for people diagnosed with irritable bowel syndrome (IBS). The most common gastrointestinal disorder affects 10% to15% of the world’s population.

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Um novo tipo de cardioversor desfibrilador implantável (CDI) extravascular usando um eletrodo (um fio fino) colocado atrás do esterno cumpre os objetivos de segurança e eficácia em participantes de estudo clínico global antes do lançamento no mercado. O dispositivo interrompeu com eficiência arritmias ventriculares agudas e crônicas potencialmente fatais. As descobertas foram apresentadas durante uma sessão de última hora no Congresso da Sociedade Europeia de Cardiologia e publicados no The New England Journal of Medicine simultaneamente.