Helena

Researchers are collecting blood and tissue samples from people with and without cancer to help evaluate new tests that could detect cancer early. This study aims to create a set of blinded blood samples from both cancer and non-cancer patients to validate these tests, focusing on multiple cancer types and stages. The goal is to improve early cancer detection through laboratory research. Participants complete a questionnaire at the start and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also have tissue samples collected at these times. The study includes patients with various cancer types and stages, as well as individuals without cancer, with some allowing enrollment before full cancer confirmation under specific conditions. During the study, researchers review the collected samples and questionnaire data to assess test performance by tumor type and clinical stage at diagnosis. Participants are followed for one year after completing the study. Key measurements include the provision of a blinded reference set of cancer versus non-cancer blood samples to support future clinical trials focused on blood-based multi-cancer early detection.

This research aims to establish a national biorepository by collecting research data and samples from patients who experience side effects from immunotherapy treatments used in cancer care. It focuses on patients who have serious immune-related reactions, rare infections, or accelerated tumor growth after receiving immuno-oncology therapies. The goal is to help researchers better predict, prevent, and treat these side effects in the future. Participants will have tissue and blood samples collected within 72 hours after confirmation of a serious immune-related side effect and again one month later. For patients experiencing colitis, stool samples may also be collected. Alongside sample collection, medical records will be reviewed for up to one year. This study is observational and involves no experimental treatments. During the study, participants will provide biospecimens at two time points and allow access to their medical records for a year. Researchers will analyze these samples and clinical data to build a resource for future studies on immune-related adverse events. The main outcome is the establishment of this biorepository, which will be maintained for up to one year after enrollment.

Researchers are comparing two treatment approaches for patients with stage II-IIIB non-small cell lung cancer NSCLC that can be removed by surgery. The study evaluates whether giving standard therapy before and after surgery perioperative is better than giving it only after surgery adjuvant. This phase III trial focuses on chemotherapy and immunotherapy, which are current standard treatments aimed at controlling tumor growth and helping the immune system fight cancer. Patients are divided into two groups. One group undergoes surgery followed by chemotherapy and immunotherapy for up to one year if the disease does not progress or cause severe side effects. The other group receives chemotherapy combined with immunotherapy before surgery, then surgery, followed by immunotherapy alone for up to one year. Chemotherapy drugs may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, or vinorelbine. Imaging tests like CT, MRI, or PETCT scans are done throughout the study. Participants will have surgery within a month of joining and receive treatments according to their assigned group. They will be monitored with scans and followed up every six months for up to 10 years to assess survival, disease progression, surgical outcomes, side effects, and immune responses. Researchers will measure event-free survival and overall survival as main results, as well as response rates and safety information over the long term.

Researchers are evaluating the effect of the Cost Communication and Financial Navigation CostCOM intervention on adherence to cancer care and financial burden in patients with malignant solid neoplasms. This study focuses on how financial hardship caused by out-of-pocket costs, employment changes, and insurance affects cancer treatment and quality of life. CostCOM aims to provide financial counseling and resource connections to reduce these burdens and improve adherence to care. Participants are randomized into two groups. One group receives a brochure describing financial navigation services Enhanced Usual Care, while the other group receives usual financial care plus CostCOM financial counseling sessions within 30 days of enrollment and again at 3, 6, and 12 months. Non-patient participants complete surveys and participate in interviews 15 to 39 months after the first patient enrollment. Participants complete surveys at baseline and at 3, 6, and 12 months to report on cost-related care non-adherence, financial hardship, financial worry, quality of life, and satisfaction with care. The study includes follow-up for 12 months after intervention completion. Non-patient participants also provide feedback on the CostCOM intervention through interviews. Researchers will monitor patient experiences and financial outcomes throughout the study.

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 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 an online educational program called Current Together After Cancer CTAC to see if it helps colorectal cancer survivors who had surgery receive follow-up care that matches current guidelines. This phase III trial focuses on patients with stage II or III colorectal cancer who have had their tumors surgically removed. The study aims to improve patients knowledge about surveillance, their confidence in managing follow-up care, and satisfaction with the involvement of a supporter in their care. Patients in the trial are randomly assigned to one of two groups. One group and their supporter get access to the CTAC intervention website, which contains educational content and interactive modules related to colorectal cancer surveillance. The other group and their supporter receive access to a general health education website. Participants may review their assigned website as often as they like for up to 16 months. During the study, participants will complete questionnaires at baseline, 3 months, and 16 months to assess knowledge, self-efficacy, cancer worry, preferences, and satisfaction with supporter engagement. Researchers will measure whether patients receive colorectal cancer surveillance aligned with guidelines at 16 months. The study also explores how supporters participation relates to patient outcomes. Participants may be contacted via email or phone for study activities and are encouraged to complete all scheduled assessments.

Researchers are tracking patients with Fabry disease through an ongoing international observational program called the Fabry Registry. This registry collects routine clinical outcomes for patients regardless of whether they are receiving treatment. The study aims to better understand the diseases variability, progression, and natural history, including in women who carry one copy of the gene, and to help improve patient care by developing monitoring recommendations and reporting outcomes. Additionally, the registry evaluates the long-term safety and effectiveness of Fabrazyme4, a treatment used in Fabry disease. The registry includes a special pregnancy sub-registry for women with Fabry disease who are pregnant or have been pregnant. This sub-registry observes pregnancy outcomes and infant growth up to 36 months after birth, collecting medical and obstetric history and treatment details. No experimental treatments are given participants continue to receive their usual care as determined by their physicians. Data from both registries support regulatory requirements and ongoing research. Participants undergo regular clinical assessments and receive standard care from their doctors throughout the study. The research team collects data on disease progression, treatment effectiveness, pregnancy outcomes, and infant development. The study is observational, meaning no study drugs or procedures are administered. The total participation can last up to 33 years, allowing for long-term monitoring of safety and outcomes related to Fabry disease and pregnancy.

Researchers are evaluating two ways of sharing genetic testing results with first-degree relatives of patients newly diagnosed with colorectal cancer. The study aims to determine whether communication by healthcare providers is more effective than communication by the patient themselves in encouraging relatives to undergo genetic testing. This is important because about 15% of colorectal cancer cases have inherited genetic variants that increase cancer risk, and relatives often do not know they may be at risk. Identifying these variants can help relatives take preventive measures.

Researchers are studying colorectal cancer CRC in participants aged 45 to 70 who have 1 to 2 non-advanced adenomas, which are small colon polyps without high-risk features. The trial compares two surveillance colonoscopy schedules one group receives colonoscopy at 5 and 10 years after polyp detection, while the other group has colonoscopy only at 10 years. This study aims to provide randomized data to guide optimal timing for follow-up colonoscopies to help reduce CRC incidence and improve clinical practices. Participants are randomly assigned to one of two groups the first group undergoes surveillance colonoscopy at both 5 and 10 years following their qualifying colonoscopy, and the second group undergoes colonoscopy at 10 years only. All colonoscopies, including any unscheduled ones, follow current quality guidelines and institutional preparation standards. The qualifying colonoscopy must have been complete and performed within 4 years before randomization, with all polyps fully removed. During the study, participants will undergo colonoscopies according to their assigned schedules. Researchers will monitor the incidence of colorectal cancer over 10 years as the primary outcome. Participants must be able to understand English or Spanish to complete required procedures. The study may last up to several decades, with ongoing monitoring to assess long-term cancer incidence and the effectiveness of different surveillance intervals.