Aitkin

The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.

Researchers are collecting blood and tissue samples from people with and without cancer to study and evaluate tests that could help detect cancer early. The goal is to create a blinded reference set of samples to validate blood-based tests for early detection of multiple types of cancer, including leukemia, lymphoma, breast, lung, and others. The study also aims to assess how well these tests perform at the time of initial cancer diagnosis, considering different tumor types and cancer stages. Participants complete a baseline questionnaire and provide blood samples at registration and again 12 months later. Those diagnosed with cancer may also provide tissue samples at these times. The study includes patients aged 40 to 75 years, with cancer diagnoses at various stages or individuals without cancer. Special procedures are in place for patients with high suspicion of certain cancers before confirmation. During the study, researchers collect detailed information through questionnaires, blood draws, and tissue sampling to analyze test accuracy. Participants are monitored for up to one year after registration to follow outcomes. The primary measure is providing this blinded set of blood samples to help validate future cancer detection tests, supporting research that could improve early diagnosis and treatment.

Researchers are evaluating three different combinations of drugs to treat newly diagnosed multiple myeloma in patients who are considered frail or intermediate-fit and are not eligible for stem cell transplant. This phase III trial focuses on comparing these three-drug induction treatments followed by either double- or single-drug maintenance therapy. The study aims to determine which treatment combination better controls the disease and improves progression-free survival and overall survival. Patients are randomly assigned to one of three treatment groups. Arm 1 (VRd-Lite) receives bortezomib by injection under the skin, lenalidomide by mouth, and dexamethasone by mouth during induction cycles, followed by lenalidomide alone for maintenance. Arm 2 (DRd-R) receives daratumumab and hyaluronidase-fihj injections, lenalidomide, and dexamethasone during induction, followed by lenalidomide alone during maintenance. Arm 3 (DRd-DR) receives the same induction as Arm 2, but maintenance includes both daratumumab and lenalidomide. Induction cycles last up to 9 cycles of 28 days each, and maintenance cycles continue every 28 days if the disease does not progress or toxicity occurs. Participants undergo assessments including tumor evaluations, whole-body imaging, blood tests, and quality-of-life questionnaires. After completing treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 10 years. Researchers will measure progression-free survival, overall survival, response rates, safety, minimal residual disease, and patient-reported health outcomes to understand the treatments' effects and support future care decisions.

Researchers are investigating whether adding the chemotherapy drug Docetaxel to the usual hormone treatments can better control metastatic castration sensitive prostate cancer (mCSPC) in patients who have a less than optimal PSA response after 6 to 12 months of androgen-targeting therapy. This phase III, open-label, randomized international trial compares the effectiveness of Docetaxel combined with standard Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitors (ARPI) versus ADT and ARPI alone. The study focuses on men with metastatic prostate adenocarcinoma who have a suboptimal PSA decline following initial hormone therapy. Participants receive standard ADT and an ARPI such as abiraterone, enzalutamide, apalutamide, or darolutamide, which are assigned before enrollment. At enrollment, patients are randomized to receive either the addition of Docetaxel chemotherapy or no chemotherapy alongside their hormone therapy. The goal is to assess whether this combination reduces cancer growth or spread compared to hormone therapy alone. Treatment begins within five working days after enrollment, with close monitoring throughout the study. Throughout the trial, participants undergo regular assessments including PSA measurements to monitor cancer activity and overall survival tracked at 39 months. Eligibility requires stable organ function, performance status, and recovery from prior treatment side effects. Patients are monitored for adverse events, safety, and treatment response. The study also ensures participants and their partners use contraception if of childbearing potential, and participants must be accessible for treatment and follow-up visits to document outcomes and safety data.

Researchers are evaluating if adding adjuvant chemotherapy (ACT) to ovarian function suppression (OFS) plus endocrine therapy (ET) improves invasive breast cancer-free survival (IBCFS) compared to OFS plus ET alone. This Phase III trial focuses on premenopausal women with early-stage breast cancer that is estrogen receptor (ER)-positive, HER2-negative, and has a 21-gene recurrence score between 16-25 for node-negative patients or 0-25 for patients with 1-3 positive nodes. The study addresses the need for better treatment options for younger women diagnosed with this type of breast cancer, as younger age is linked to worse outcomes despite standard therapies. Participants receive one of two treatments: either OFS combined with an aromatase inhibitor (AI) for five years or adjuvant chemotherapy followed by the same OFS plus AI regimen. The specific AI and GnRH agonist used, along with their dosing schedules, are chosen by the investigator, commonly including goserelin, leuprolide, or triptorelin administered monthly or every three months. Bilateral oophorectomy may be used instead of ovarian suppression if preferred. Endocrine therapy beyond five years is at the investigator's discretion. During the trial, participants will be closely monitored for invasive breast cancer-free survival over an 11-year period from randomization. Assessments include clinical evaluations, hormone receptor testing, tumor staging, and genetic recurrence scoring prior to enrollment. Safety and effectiveness data will be collected throughout the study, with particular attention to treatment side effects and long-term outcomes. The trial involves detailed eligibility screening and ongoing follow-up to ensure accurate measurement of the study's primary outcome.

Researchers are studying how social and genetic factors affect outcomes for adolescent and young adult (AYA) survivors of Hodgkin and non-Hodgkin lymphoma. Compared to children and older adults, AYAs with these cancers face unique biological, clinical, psychological, and social challenges that influence their risk of illness and early death after treatment. By collecting blood samples and detailed health and treatment information, the study aims to better understand these risks and improve support for AYA cancer survivors. Participants in this observational study provide blood samples and complete health-related quality of life questionnaires at the start of the study and again at 6, 12, 18, and 24 months. The study examines how social-environmental risk factors and individual resilience relate to disease-free survival, overall survival, and quality of life. It also explores how gene expression changes may mediate these effects and whether factors like race, sex, gender identity, and geography influence outcomes. Throughout the two-year period, researchers monitor participants for disease-free survival, overall survival, and comorbidities including symptoms and late effects. The study collects repeated assessments through questionnaires and blood draws to track health status, quality of life, and biological markers. This comprehensive approach helps identify factors that impact long-term health for adolescent and young adult lymphoma survivors.

Researchers are evaluating an online educational program called Current Together After Cancer (CTAC) designed to help patients who have had surgery for stage II or III colorectal cancer receive follow-up care that follows current medical guidelines. This phase III trial aims to see if CTAC improves patients' knowledge about surveillance, their confidence in managing their care, and satisfaction with support received from a chosen adult supporter. Proper surveillance after colorectal cancer surgery is important to detect any return of the disease early, but many survivors do not receive recommended follow-up care, possibly due to lack of information or support. Participants are randomly assigned to one of two groups. One group receives access to the CTAC intervention website, which includes educational content and interactive modules to help manage post-surgery surveillance. The other group accesses a control website with general health education. Both patients and their chosen supporters can use their assigned website as often as they like for up to 16 months. Supporters are adult individuals identified by the patient who help with their cancer journey. During the study, researchers will measure how many patients receive surveillance care that follows guidelines at 12 and 16 months. They will also assess patients' knowledge about surveillance, confidence in managing their care, and satisfaction with supporter involvement at 3 and 16 months. Surveys and interviews will be conducted to gather this information. The study will also explore how well the intervention fits into clinical practice and how supporter participation affects outcomes.

Researchers are evaluating the incidence of colorectal cancer in people aged 45 to 70 who have 1 to 2 non-advanced adenomas, which are small precancerous polyps without high-risk features. The study compares outcomes between those who have surveillance colonoscopies every 5 years versus every 10 years. This is important because current guidelines recommend follow-up colonoscopy but lack clear evidence on the best timing for patients with non-advanced adenomas. Participants will undergo colonoscopies at either 5 and 10 years or just at 10 years after their initial qualifying colonoscopy. All colonoscopies, including any unscheduled ones, will follow standard quality procedures and preparation instructions. The initial colonoscopy must have fully visualized the cecum and completely removed all polyps. Sessile serrated polyps without advanced features are also included as non-advanced adenomas. During the trial, researchers will monitor participants through colonoscopy exams and collect data on the incidence of colorectal cancer over a 10-year period. The main measurement is the rate of colorectal cancer occurrence. The study also includes assessments to ensure adherence to colonoscopy quality standards and will follow participants long term to observe safety and effectiveness of the surveillance intervals.

Researchers are evaluating how well inotuzumab ozogamicin works when combined with frontline chemotherapy in treating young adults aged 18 to 39 years who have newly diagnosed B acute lymphoblastic leukemia (ALL). This Phase III trial aims to confirm the safety and effectiveness of adding inotuzumab ozogamicin, a monoclonal antibody that targets cancer cells, to a pediatric-inspired chemotherapy regimen called CALGB 10403. The study also explores the impact of this combination on survival, minimal residual disease, genetic factors, treatment side effects, and medication adherence. Participants begin with remission induction therapy that includes oral allopurinol, intravenous and intrathecal chemotherapy drugs such as daunorubicin, vincristine, dexamethasone, pegylated L-asparaginase, and methotrexate, along with bone marrow tests. Those who respond to induction are randomized to one of two groups: one receives standard chemotherapy courses including consolidation, maintenance, and intensification phases, while the other receives inotuzumab ozogamicin infusions in addition to the same chemotherapy regimen. Treatments are given by mouth, intravenous, subcutaneous, or intrathecal routes on specific days over several courses lasting up to three years for maintenance therapy. Throughout the study, participants undergo regular bone marrow biopsies, blood tests, and biomarker analyses to monitor disease status and treatment effects. Researchers assess event-free survival, disease-free survival, overall survival, treatment toxicity, genetic markers, and medication adherence using electronic monitoring. After treatment ends, patients are followed monthly for the first year, then less frequently up to ten years to track long-term outcomes and safety.

Researchers are evaluating the Integrated Cancer Repository for Cancer Research (iCaRe2), a comprehensive multi-institutional resource developed by the Fred & Pamela Buffett Cancer Center. This resource collects and manages standardized, multi-dimensional, and longitudinal data and biospecimens from adult cancer patients, those at high risk, and normal controls. iCaRe2 includes data from a wide geographic area covering many small and rural hospitals and cancer centers, supporting studies on cancer risk factors, development, progression, and strategies for prevention, screening, early detection, and personalized treatment. iCaRe2 is a web-based, secure, HIPAA-compliant registry that integrates multiple specialized cancer collaborative registries covering a broad range of cancers such as pancreatic, breast, thyroid, thoracic, genitourinary, gastrointestinal, central nervous system, leukemia, gynecological, sarcoma, melanoma, and more. The system allows participating centers to contribute data and biospecimens like tumor samples, germ line DNA, serum, urine, and plasma. This flexible "confederation model" enables centers with different expertise and resources to collaborate on diverse research projects through a common platform. Participants include adult individuals aged 19 and older who have a cancer diagnosis or history, are at risk for cancer, have suspicious clinical findings, or have no history of cancer (normal controls). Data collection includes demographic, clinical, and biospecimen information. The registry supports multi-dimensional data mining and sharing to advance cancer research. The primary outcome is the ongoing development and implementation of this web-based cancer collaborative registry, with long-term data collection and collaboration planned over many years.