Antony

Researchers are evaluating how well a special imaging scan called 68Ga-FAPI-46 PETCT can predict the response of early-stage high-risk triple-negative breast cancer TNBC to treatment before starting therapy. This study focuses on patients receiving a combination of pembrolizumab, a type of immunotherapy, with chemotherapy as a standard care approach. The study is prospective and involves multiple centers collaborating to understand treatment outcomes better. Patients will receive pembrolizumab at a dose of 200 mg every three weeks alongside 4 cycles of paclitaxel plus carboplatin chemotherapy, followed by 4 cycles of either doxorubicin or epirubicin plus cyclophosphamide. After surgery to remove the tumor, participants will continue with up to 9 cycles of pembrolizumab as adjuvant therapy or until cancer returns or unacceptable side effects occur. Before treatment begins, each patient will have a 68Ga-FAPI-46 PETCT scan performed within 14 days, using the same machine as the standard 18F-FDG PETCT scan. During the study, researchers will collect imaging data and monitor patients throughout the entire treatment and follow-up period. They will assess how well the imaging scan predicts the tumors histological response to therapy by measuring outcomes such as the area under the ROC curve at 6 months. The study will also compare the predictive and prognostic performance of the 68Ga-FAPI-46 PETCT scan against the standard 18F-FDG PETCT scan. Participants will be followed closely for safety and treatment response during the neoadjuvant, surgical, and adjuvant phases of care, with the study ending by November 2032.

Hidradenitis suppurativa HS is a painful inflammatory skin condition affecting areas like the underarms, groin, and genital regions. This trial evaluates the safety and effectiveness of upadacitinib, an oral drug approved for other inflammatory diseases, in adults and adolescents with moderate to severe HS who have not responded well or cannot tolerate anti-TNF therapies. The study is double-blinded and involves multiple treatment periods to assess disease activity and side effects. Participants will take oral tablets of either upadacitinib or a placebo once daily during the first two periods, each lasting 36 weeks. In Period 1, participants are randomly assigned to receive either upadacitinib or placebo. Period 2 assigns participants to one of six groups based on their response in Period 1, with treatment continuing for 20 weeks. In Period 3, eligible participants continue their assigned treatment for an additional 68 weeks, followed by a 30-day follow-up. Throughout the study, participants will attend regular outpatient visits where medical assessments will monitor treatment effects and side effects. Questionnaires and clinical evaluations will be completed to measure changes in disease activity and quality of life. The trial aims to track the percentage of participants achieving clinical response and the occurrence of adverse events over the entire study duration, which may be longer than standard care treatments.

Researchers are evaluating whether the medicine spesolimab can help adults with ulcerative pyoderma gangrenosum PG, a skin condition characterized by painful ulcers. The main goal is to see if spesolimab can lead to healing and closure of these ulcers. This Phase 3 study includes adults with at least one ulcer measuring between 5 cm and 80 cm and is sponsored by LEO Pharma. The study has two parts. In Part 1, participants are randomly assigned to receive either spesolimab or a placebo infusion every 4 weeks, with a 2 in 3 chance of receiving spesolimab. Alongside this, all participants take corticosteroid medicine by mouth for the first 8 weeks. In Part 2, participants are grouped again, where those without open ulcers have an equal chance of receiving spesolimab or placebo, while those with open ulcers receive spesolimab. Treatment infusions continue every 4 weeks throughout the study. Participants will be involved in the study for about 1.5 years, attending around 20 visits to the study site. During visits, doctors will examine their skin for signs of PG, monitor their overall health, and check for any side effects. The study team will compare results between groups, focusing especially on the complete closure of ulcers up to 28 weeks, among other measures of skin healing and pain reduction.

Researchers are studying an experimental drug called linvoseltamab in adults newly diagnosed with symptomatic multiple myeloma who have not yet received treatment. The study aims to evaluate the safety, tolerability, and effectiveness of linvoseltamab, particularly how it may shrink tumors and work before and after stem cell transplant. This trial includes phases to find the right dosing and to monitor side effects and responses over time. Linvoseltamab is given by intravenous infusion in different dosing schedules. The study has several parts Phase 1 includes dose escalation and evaluation of alternative dosing regimens, while Phase 2 treats transplant-eligible participants for a fixed time and transplant-ineligible participants until disease progression with the selected dosing. The study evaluates linvoseltamab both before and after autologous stem cell transplantation. Participants will be closely monitored through various assessments including tracking side effects, measuring drug levels in the blood, and checking for antibodies against the drug. Response to treatment is measured by tumor shrinkage and minimal residual disease status up to five years. Safety monitoring continues up to 90 days after the last dose, with long-term follow-up for treatment effectiveness and survival. The study duration varies depending on transplant eligibility and treatment response.

Researchers are studying Brivekimig, a medication given as a subcutaneous injection, in people with moderate to severe hidradenitis suppurativa HS. This Phase 2b, global, randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of different doses of Brivekimig for treating HS. Participants have had HS for at least six months and have moderate to severe symptoms affecting multiple areas of the body. Participants will be randomly assigned to receive one of three dosing regimens of Brivekimig or a matching placebo. The study drug is given through injections and the treatment period lasts up to approximately 48 weeks. Some participants may continue into a longer-term extension study, making total participation last up to about 52 to 60 weeks. The trial includes a maintenance period following the initial treatment. During the study, participants will have regular visits to assess their skin condition, pain levels, quality of life, and any side effects. Researchers will measure improvements using tools like the Hidradenitis Suppurativa Clinical Response HiSCR at various points up to Week 16. Safety will be monitored throughout the study, including tracking adverse events and laboratory tests. Participants drug levels and immune responses will also be checked. Overall, the trial will last up to about 60 weeks depending on extension participation.

This observational study involves patients diagnosed with chronic myelomonocytic leukemia, a type of leukemia characterized by increased monocytes in the blood. The purpose is to better understand the diseases underlying mechanisms, with data collected over an average of 15 years. Biological samples and anonymized data will be gathered during routine care or clinical trials to support this research. The study is sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Participants will have biological samples collected, including blood and bone marrow, during scheduled medical assessments. Blood samples include standard tubes and may vary based on research needs, while bone marrow samples are taken during routine myelograms. In exceptional cases, tissue samples may be collected during surgical procedures if agreed upon with the surgeon. These collections occur alongside usual medical care without additional interventions. Throughout the study, participants will undergo sample collections aligned with their medical visits and tests. Researchers will analyze these samples and associated anonymized data to study the diseases pathophysiology. Participation involves no investigational treatments, and the study will monitor participants for up to 15 years to gather long-term data. Safety and routine care continue as usual during this period.

Researchers are investigating how Mucosal-Associated Invariant T MAIT cells interact with the gut microbiota and gut lining in children at risk for or recently diagnosed with type 1 diabetes T1D. The study compares three groups children with recent onset T1D, children genetically at risk for T1D, and healthy control children. The goal is to understand changes in MAIT cells, gut health, and the presence of Coxsackie virus B that may relate to the development and progression of T1D. The study involves detailed analysis of blood samples to measure MAIT cell frequency, activation, exhaustion, and function using specialized laboratory tests. Stool samples are collected to study gut bacteria and the presence of Coxsackie virus B. Some participants undergo a gut permeability test involving sugar drinks and urine collection, while others may have duodenal biopsies taken during upper gastrointestinal endoscopy to study the gut lining and immune response. These procedures help assess gut integrity and immune markers. Participants will have samples collected at enrollment or shortly after diagnosis, including blood, stool, and possibly urine or biopsy samples. Researchers will analyze MAIT cells, gut bacteria, viral presence, and gut lining markers. The study measures how these factors relate to T1D development. Safety is monitored through medical history review and eligibility screening. Participation duration depends on enrollment timing, with assessments focused on baseline and related analyses.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

Neurological disorders like cerebral palsy can cause significant motor challenges that affect daily life, especially in children. This research evaluates the use of intensive, repetitive training focused on reach-to-grasp movements to improve hand function in children aged 4 to 17 years with such motor impairments. The study explores a new approach combining serious gaming with physical training to make repetitive therapy more engaging and effective. Participants will engage in a 4-week intervention involving three 40-minute sessions per week using a specialized serious game. This game includes software, a physical platform, and instrumented toys designed to encourage grasp-and-release and reach-to-grasp actions through repeated movements. The therapy aims to provide about 4 hours of gameplay, with sessions including specific tasks like the Box and Blocks Test and range of motion exercises. Children will first complete baseline assessments measuring manual dexterity and wrist movement, along with the Assisting Hand Assessment. After the intervention, these tests will be repeated, and a follow-up evaluation will occur two months later to measure lasting effects. Researchers will track improvements using the Box and Blocks Test, active wrist range of motion, and the Assisting Hand Assessment to understand the therapys impact.

Researchers are evaluating the effectiveness of the Apneal4 app on smartphones for diagnosing sleep apnea syndrome SAS in adults who require polysomnography PSG as part of their routine care. The study aims to determine if Apneal4 can accurately classify SAS severity into four categories, estimate the Apnea-Hypopnea Index AHI, detect sleep stages, differentiate between central and obstructive apneas, and identify patient movements compared to PSG. Participants will wear a smartphone equipped with the Apneal4 app on their chest during a full night of sleep at home while undergoing polysomnographic recording. They will also complete several questionnaires assessing sleep symptoms and their experience with the Apneal4 app. The study will monitor these measures over an average of one year to evaluate device performance and patient acceptability. During the study, participants will be assessed using both the Apneal4 device and standard PSG. Researchers will compare Apneal4 results with screening questionnaires like NoSAS, Berlin, and Epworth. Participants will complete questionnaires about their sleep symptoms and the devices ease of use. The primary outcome is the performance of Apneal4 in diagnosing sleep apnea-hypopnea syndrome. Safety and feasibility will be monitored throughout the study, which is expected to last about one year per participant.