Paoli

Researchers are conducting an observational registry to collect standardized data from adult patients receiving routine oncology care at participating cancer centers. The study aims to gather detailed information such as baseline patient characteristics, treatments administered, and outcomes to support research and improve clinical trial participation. Patient surveys are also included to enrich the data collected. No treatments or interventions are given as part of this registry. Instead, data is gathered from patients receiving their usual cancer care. This open-ended registry will continuously collect and analyze information over time to better understand treatment patterns, safety, and effectiveness. Participants will provide informed consent and contribute data through their regular care visits and surveys. Researchers will monitor treatment effectiveness mainly by tracking the time until treatment discontinuation. The registry will regularly analyze and present the data collected. Participation may last as long as the patient is receiving treatment and contributing data, with long-term follow-up possible.

Researchers are evaluating the effectiveness of amivantamab combined with either lazertinib or platinum-based chemotherapy in treating participants who have epidermal growth factor receptor mutated EGFRm non-small cell lung cancer NSCLC. This study focuses on advanced or metastatic NSCLC cases where standard curative treatments are not suitable. It aims to assess the antitumor activity of these treatment combinations in this patient population. Participants receive either amivantamab with oral lazertinib in 28-day cycles or amivantamab with intravenous chemotherapy consisting of carboplatin and pemetrexed in 21-day cycles. Treatment continues until disease progression, participant withdrawal, death, or investigator decision to stop treatment. The study is designed with two separate groups receiving these distinct treatment combinations. Throughout the study, participants will undergo assessments to monitor treatment effects and safety. Researchers will measure progression-free survival as the primary outcome up to 4 years and 6 months, along with secondary outcomes including dose adjustments, adverse events, overall survival, response rates, and duration of response. Participants are followed regularly during treatment to track these outcomes and manage any side effects until the studys completion.

Researchers are studying two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 genetic mutations. This trial compares bilateral salpingectomy, which removes only the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The goal is to find out if removing just the fallopian tubes with delayed ovary removal is nearly as effective as removing both from the start. Participants choose between two groups one undergoes bilateral salpingectomy with the option of later ovary removal, and the other undergoes bilateral salpingo-oophorectomy. Both groups have imaging tests like pelvic ultrasounds or pelvic MRIs during screening and provide blood samples throughout the study. Follow-up visits occur at multiple time points, including 10 to 60 days, 6 months, 12 months, 24 months, and then yearly for up to 20 years. During the study, researchers track if ovarian or related cancers develop and assess symptoms related to estrogen loss, quality of life, cancer-related distress, sexual function, menopausal symptoms, medical decision making, and any adverse events. Various questionnaires and imaging tests support these evaluations. Long-term safety and cancer risk reduction are monitored for up to two decades after surgery.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy regimen can improve outcomes for patients with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial focuses on comparing breast cancer event-free survival and other measures between patients receiving chemotherapy alone and those receiving chemotherapy with durvalumab. Immunotherapy may help enhance the bodys immune response against cancer, while chemotherapy works to stop tumor growth in various ways. Participants are first tested for MP2 status using MammaPrint on previously collected tissue. Those with MP2 results are randomized into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for six cycles, followed by doxorubicin and cyclophosphamide intravenously every 14 days for four cycles. The other group receives the same chemotherapy schedule combined with durvalumab given intravenously over 60 minutes on specific cycles. Mammography and optional tumor tissue and blood sample collections occur during the study. During the study, participants undergo assessments including mammography, tumor biopsies, blood tests, and quality-of-life questionnaires. Researchers measure outcomes such as event-free survival, response rates, relapse-free survival, overall survival, treatment side effects, and patient-reported fatigue and physical health. After treatment completion, participants are followed for up to 10 years to monitor long-term outcomes and survival. Specimens are also banked for future research.

Researchers are evaluating a new approach to adjuvant treatment for patients with early-stage endometrial cancer characterized by POLE mutations or p53 wildtypeno specific molecular profile. This Phase II study compares this tailored treatment approach to the usual care, which typically involves surgery followed by additional therapy decisions based on pathology results. The study includes two sub-studies focusing on these molecular types of endometrial cancer. Participants may receive one of several interventions including observation alone, observation combined with adjuvant radiotherapy, or observation combined with vaginal brachytherapy. Radiotherapy uses specific photon energies and imaging for treatment planning, while vaginal brachytherapy is delivered with a vaginal cylinder or ovoids. Treatment starts within 10 weeks after surgery, and patients are assigned to groups based on their tumor molecular status. During the study, participants are monitored for recurrence rates in the pelvis, vagina, para-aortic area, and distant sites over 3 years, as well as recurrence-free survival, cancer-specific survival, and overall survival over 9 years. Patient-reported outcomes on fear of recurrence are also collected. Careful follow-up and data collection continue throughout the study, which concludes in 2029, ensuring thorough evaluation of this tailored treatment approach.

Researchers are studying the effects of adding olaparib, a PARP inhibitor, after surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have mutations in BRCA1, BRCA2, or PALB2 genes. This phase II trial aims to see if olaparib can improve relapse-free survival compared to placebo. The study also evaluates overall survival and differences in outcomes based on mutation type and prior chemotherapy treatment. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, unless the disease progresses or side effects occur. During the treatment, patients will have CT or MRI scans and blood samples taken regularly. After treatment, participants will be followed up at 30 days, every 4 months for the first year, then every 6 months for up to 10 years. Throughout the study, patients will undergo imaging and blood tests to monitor their health and detect any recurrence of cancer. The main outcome measured is the time from randomization to disease recurrence or death. Researchers will also track overall survival for up to 10 years. Safety will be monitored, and participants will be observed regularly after treatment to assess long-term effects and disease status.

Researchers are evaluating the LivIQ leadless pacemaker system in patients who need ventricular pacing according to Class I or II guidelines. This study aims to confirm the devices safety and performance, including a sub-study focused on its ability to maintain atrioventricular synchrony. The trial is open-label, prospective, single-arm, and conducted internationally across multiple centers. Participants will receive the LivIQ leadless pacemaker, implanted directly into the right ventricle. The study includes a main phase and an integrated atrioventricular synchrony sub-study, where specific heart rhythm data is collected at 1 and 6 months. Follow-ups occur at implant, pre-hospital discharge, 1, 3, 6, and 12 months, then every 6 months until market approval, with a remote 24-month visit after U.S. approval. Participants undergo regular on-site examinations and monitoring including device performance checks and health questionnaires. The study measures freedom from serious device-related effects, pacing adequacy, sensing performance, quality of life, battery longevity, and survival at 24 months. Participants are expected to complete all scheduled visits over the study duration, which may extend beyond two years.

Researchers are evaluating treatments for older adults aged 70 and above with advanced stage IIIB-IV non-small cell lung cancer that expresses PD-L1 in 1-49% of tumor cells. This phase III trial compares the effects of adding chemotherapy to immunotherapy with pembrolizumab against pembrolizumab alone. The study aims to assess improvements in overall survival, progression-free survival, response rates, toxicity, quality of life, and explore geriatric assessment factors and gut microbiome correlations. Participants are randomly assigned to one of two groups. Arm A receives pembrolizumab intravenously every 21 days for four cycles, followed by maintenance pembrolizumab every 21 or 42 days for up to two years. Arm B receives the same pembrolizumab schedule plus one of several chemotherapy regimens, including combinations of pemetrexed, carboplatin, nab-paclitaxel, or paclitaxel administered intravenously on different schedules for four cycles, followed by pembrolizumab maintenance. Imaging with MRI, CT, and PET scans is performed at baseline and throughout the trial. During the study, participants undergo regular assessments including imaging scans to monitor disease status, blood tests, and quality of life questionnaires. After treatment completion, follow-up visits occur every three months for up to two years and then every six months up to five years. Researchers measure overall survival as the primary outcome and also track progression-free survival, response rates, adverse events, and patient-reported quality of life. Safety and tolerability are closely monitored along with exploratory analyses of chemotherapy dose intensity and microbiome factors.

This research aims to compare two methods of monitoring pancreatic cysts and to identify biomarkers that may help detect the risk of these cysts turning into pancreatic cancer. The study evaluates whether more frequent monitoring or less frequent monitoring leads to better patient outcomes and explores various blood and imaging biomarkers for improved risk prediction. Participants are observed through two different surveillance approaches that were previously randomized but are now closed to new enrollment. One approach involves lower intensity monitoring with MRI, CT, or endoscopic ultrasound EUS scans spaced out over years, while the other involves higher intensity monitoring with more frequent imaging based on cyst size. Throughout the study, patients may also provide blood samples and undergo biopsies, fine needle aspirations, or surgery as needed. Participants are followed up regularly for five years from registration, with imaging and blood tests at intervals depending on their assigned monitoring method. Researchers collect data on clinical features, anxiety, quality of life, financial distress, healthcare costs, and outcomes such as the development of concerning pancreatic cyst features or pancreatic cancer. The study uses these measures to assess the effectiveness of monitoring strategies and the predictive value of biomarkers.

Researchers are evaluating if active surveillance combined with hormonal therapy can effectively manage ductal cell carcinoma in situ DCIS, an early stage of breast cancer. This study aims to determine whether new endocrine therapies increase the number of patients suitable for long-term active surveillance instead of surgery, which often has significant health effects. The trial is a Phase 2 randomized study focusing on treatment options for hormone receptor-positive DCIS in women. Participants will receive one of several hormonal treatments standard or low-dose tamoxifen for premenopausal women, aromatase inhibitors for postmenopausal women, or investigational therapies including a testosterone plus anastrazole pellet, elacestrant, or z-endoxifen capsules. Treatments are taken orally or via subcutaneous pellet insertion, with dosing schedules ranging from daily oral medication to pellet insertion every three months, continuing for up to three years. Participants undergo MRI evaluations at baseline, 3 months, and 6 months, followed by alternating MRI and mammogram scans every 6 months for up to 5 years. If evaluations suggest surgery is needed, participants stop the study treatment and proceed with surgery as standard care. During the study, participants provide blood samples to assess immune status, saliva samples for genetic testing, and tissue samples from any surgery performed as part of their care. They are followed annually for 10 years to monitor outcomes. The main outcome measured is the number of patients remaining on active surveillance at 7 months. Secondary outcomes assess long-term suitability for surveillance, progression to invasive cancer, quality of life, lesion changes on imaging, adherence to surveillance, and risk predictions based on mammography over several years.