294 results match your criteria: "Clinical Trials and Statistics Unit[Affiliation]"
Disabil Rehabil
June 2024
Medical Doctor, Physical Medicine and Rehabilitation Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
Purpose: To verify the effectiveness of experimental occupational therapy plus intensive standard rehabilitation compared to intensive standard rehabilitation alone on the reintegration to social activities of complex patients three months after hospital discharge.
Materials And Methods: Patients with a score ≥ 9 on the Rehabilitation Complexity Scale at admission to an intensive rehabilitation ward were randomized to the control or experimental group. Both groups received intensive multidisciplinary rehabilitation aimed at recovering independence in the basic activities of daily life (ADL).
J Clin Oncol
July 2023
Medical Research Council (MRC) Molecular Haematology Unit, MRC Weatherall Institute of Molecular Medicine, NIHR, Biomedical Research Centre, University of Oxford, Oxford, United Kingdom.
Breast
June 2023
Clinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, Sutton, London, UK. Electronic address:
This overview provides the historical perspective of external beam breast hypofractionation over the last 50 years. It highlights the serious harm suffered by patients with breast cancer in the 1970's and 1980's because of new hypofractionation regimens based on a theoretical radiobiology model being adopted into clinical practice to solve a resource issue without testing within clinical trials and without the essential radiotherapy quality assurance. It then describes the high-quality clinical trials comparing 3-week with 5-week standard of care regimens that were initiated based on a strong scientific rationale for hypofractionation in breast cancer.
View Article and Find Full Text PDFHealthcare (Basel)
April 2023
Psycho-Oncology Unit, Azienda USL-IRCCS di Reggio Emilia, 42123 Reggio Emilia, Italy.
Background: Health information concerns both individuals' engagement and the way services and professionals provide information to facilitate consumers' health decision making. Citizens' and patients' participation in the management of their own health is related to the availability of tools making health information accessible, thus promoting empowerment and making care more inclusive and fairer. A novel instrument was developed (Evaluation Tool of Health Information for Consumers-ETHIC) for assessing the formal quality of health information materials written in Italian language.
View Article and Find Full Text PDFBreast Cancer Res
April 2023
Ralph Lauren Centre for Breast Cancer Research, Royal Marsden Hospital, and Breast Cancer Now Centre, The Institute of Cancer Research, London, UK.
Purpose: Ki67 assessed at diagnosis (Ki67) is an important prognostic factor in primary oestrogen receptor-positive (ER +) breast cancer. Proportional change in Ki67 after 2 weeks (∆Ki67) is associated with clinical benefit from endocrine therapies and residual Ki67 (Ki67) with recurrence-free survival. The aim was to define the association between Ki67 and after aromatase inhibitor (AI) exposure ∆Ki67 and Ki67 with key prognostic and biologic factors utilising data from the POETIC study.
View Article and Find Full Text PDFAm J Hosp Palliat Care
January 2024
Qualitative Research Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
When conscious, about 50% to 60% of hospice patients report a "visitation" by someone who is not there while they dream or are awake: a phenomenon known as End-of-Life Dreams and Visions (ELDVs). Since the dying process is frequently complicated by delirium, ELDVs risk being misidentified as such by professionals and caregivers. To observe these phenomena from patients' perspectives, we conducted a systematic review to aggregate and synthesize the findings from the qualitative studies about ELDVs of patients assisted in hospices to indicate future directions for research and care.
View Article and Find Full Text PDFClin Oncol (R Coll Radiol)
June 2023
Department of Oncology, University of Cambridge, Cambridge, UK.
Clin Oncol (R Coll Radiol)
May 2023
The Institute of Cancer Research, London, UK.
Aims: To evaluate whether there is sufficient correlation between patient-reported outcomes (PROs) and clinician-reported outcomes (CROs) in bladder cancer follow-up post-radiotherapy to streamline data collection and to reduce trial follow-up burden on patients, clinicians and trial programmes.
Materials And Methods: PROs data were collected within the BC2001 trial using the Functional Assessment of Cancer Therapy specific to bladder cancer (FACT-BL) questionnaire. CROs data were collected by clinicians using Late Effects in Normal Tissues Subjective, Objective and Management (LENT/SOM).
BMJ Open
March 2023
Health Services Research, Evaluation and Policy Unit, Azienda USL della Romagna, Ravenna, Italy.
Objective: To explore the pattern of health services utilisation of people who had had a documented SARS-Cov-2 infection.
Design: Retrospective cohort study.
Setting: The Italian province of Reggio Emilia.
Radiother Oncol
June 2023
Division of Cancer Sciences, University of Manchester, Manchester, UK; Radiology, The Christie NHS Foundation Trust, Manchester, UK; Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, UK.
Background And Purpose: Tumour hypoxia is prognostic in head and neck cancer (HNC), associated with poor loco-regional control, poor survival and treatment resistance. The advent of hybrid MRI - radiotherapy linear accelerator or 'MR Linac' systems - could permit imaging for treatment adaptation based on hypoxic status. We sought to develop oxygen-enhanced MRI (OE-MRI) in HNC and translate the technique onto an MR Linac system.
View Article and Find Full Text PDFBMJ Open
March 2023
Clinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, Sutton, UK.
Objectives: There is a global increase in the number of women diagnosed with cancer during their pregnancy and a nascent evidence base to guide their supportive care. The purposes of this study were to (1) map research on the psychosocial issues affecting women and their partners on diagnosis and treatment for cancer during pregnancy; (2) determine available supportive care or educational interventions; and (3) identify knowledge gaps for future research and development.
Design: Scoping review.
Cancers (Basel)
February 2023
The Royal Marsden NHS Foundation Trust, London SM2 5PT, UK.
Several studies have demonstrated the association between acute and late radiotherapy toxicity in prostate cancer using older radiotherapy techniques. However, whether this association is present with newer techniques such as stereotactic body radiotherapy (SBRT), remains unclear. We use univariable and multivariable logistic regression to analyse the association between grade 2 or worse acute gastrointestinal (GI) and genitourinary (GU) toxicities with equivalent late toxicities in patients treated with SBRT and conventional or moderately fractionated radiotherapy (CRT) within the PACE-B study.
View Article and Find Full Text PDFInt J Radiat Oncol Biol Phys
August 2023
Clinical Trials and Statistics Unit, Institute of Cancer Research, London, United Kingdom. Electronic address:
Purpose: The CHHiP trial assessed moderately hypofractionated radiation therapy in localized prostate cancer. We utilized longitudinal prostate-specific antigen (PSA) measurements collected over time to evaluate and characterize patient prognosis.
Methods And Materials: We developed a clinical dynamic prediction joint model to predict the risk of biochemical or clinical recurrence.
Clin Oncol (R Coll Radiol)
May 2023
The Royal Marsden NHS Foundation Trust, Sutton, UK; Radiotherapy and Imaging Division, Institute of Cancer Research, London, UK.
Aims: Stereotactic body radiotherapy (SBRT) is increasingly used to treat sacral metastases. We analysed our centre's local relapse rates and patterns of failure after sacral SBRT and assessed whether using the consensus contouring recommendation (CCR) may have prevented local relapse.
Materials And Methods: We conducted a single-centre retrospective review of patients treated with sacral SBRT between February 2012 and December 2021.
EBioMedicine
February 2023
Division of Radiotherapy and Imaging, The Institute of Cancer Research, London, United Kingdom; Royal Marsden Hospital, Sutton, United Kingdom.
Background: Protein markers of cellular proliferation, hypoxia, apoptosis, cell cycle checkpoints, growth factor signalling and inflammation in localised prostate tumours have previously shown prognostic ability. A translational substudy within the CHHiP trial of radiotherapy fractionation evaluated whether these could improve prediction of prognosis and assist treatment stratification following either conventional or hypofractionated radiotherapy.
Methods: Using case:control methodology, patients with biochemical or clinical failure after radiotherapy (BCR) were matched to patients without recurrence according to established prognostic factors (Gleason score, presenting PSA, tumour-stage) and fractionation schedule.
Trials
December 2022
Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, SM2 5NG, UK.
Ann Oncol
February 2023
Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.
Background: Post-treatment detection of circulating tumour DNA (ctDNA) in early-stage triple-negative breast cancer (TNBC) patients predicts high risk of relapse. c-TRAK TN assessed the utility of prospective ctDNA surveillance in TNBC and the activity of pembrolizumab in patients with ctDNA detected [ctDNA positive (ctDNA+)].
Patients And Methods: c-TRAK TN, a multicentre phase II trial, with integrated prospective ctDNA surveillance by digital PCR, enrolled patients with early-stage TNBC and residual disease following neoadjuvant chemotherapy, or stage II/III with adjuvant chemotherapy.
Breast Cancer Res Treat
January 2023
Centre for Health Economics, University of York, Heslington, UK.
Purpose: We estimated the cost-effectiveness of 4 radiotherapy modalities to treat early breast cancer in the UK. In a subgroup of patients eligible for all modalities, we compared whole-breast (WB) and partial breast (PB) radiotherapy delivered in either 15 (WB15F, PB15F) or 5 fractions (WB5F, PB5F). In a subgroup ineligible for PB radiotherapy, we compared WB15F to WB5F.
View Article and Find Full Text PDFHealth Technol Assess
October 2022
Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.
Background: Around 7500 people are diagnosed with non-muscle-invasive bladder cancer in the UK annually. Recurrence following transurethral resection of bladder tumour is common, and the intensive monitoring schedule required after initial treatment has associated costs for patients and the NHS. In photodynamic diagnosis, before transurethral resection of bladder tumour, a photosensitiser that is preferentially absorbed by tumour cells is instilled intravesically.
View Article and Find Full Text PDFJ Clin Oncol
February 2023
Department of Radiation Oncology, University of California, Los Angeles, CA.
Cancers (Basel)
September 2022
Medical Physics Unit, Azienda USL-IRCCS di Reggio Emilia, 42123 Reggio Emilia, Italy.
Glioblastoma multiforme (GBM) is the most aggressive astrocytic primary brain tumor, and concurrent temozolomide (TMZ) and radiotherapy (RT) followed by maintenance of adjuvant TMZ is the current standard of care. Despite advances in imaging techniques and multi-modal treatment options, the median overall survival (OS) remains poor. As an alternative to surgery, re-irradiation (re-RT) can be a therapeutic option in recurrent GBM.
View Article and Find Full Text PDFAnn Oncol
December 2022
The Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London; The Breast Cancer Now Unit, Guy's Hospital Cancer Centre, King's College London, London, UK. Electronic address:
Background: The randomized, double-blind OlympiA trial compared 1 year of the oral poly(adenosine diphosphate-ribose) polymerase inhibitor, olaparib, to matching placebo as adjuvant therapy for patients with pathogenic or likely pathogenic variants in germline BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative, early breast cancer (EBC). The first pre-specified interim analysis (IA) previously demonstrated statistically significant improvement in invasive disease-free survival (IDFS) and distant disease-free survival (DDFS). The olaparib group had fewer deaths than the placebo group, but the difference did not reach statistical significance for overall survival (OS).
View Article and Find Full Text PDFClin Cancer Res
October 2022
School of Cancer and Pharmaceutical Sciences, King's College London, UK.
Purpose: To identify potential immune targets in post-neoadjuvant chemotherapy (NAC)-resistant triple-negative breast cancer (TNBC) and ER+HER2- breast cancer disease.
Experimental Design: Following pathology review, 153 patients were identified as having residual cancer burden (RCB) II/III disease (TNBC n = 80; ER+HER2-n = 73). Baseline pre-NAC samples were available for evaluation for 32 of 80 TNBC and 36 of 73 ER+HER2- cases.
BMC Med Res Methodol
September 2022
Clinical Trials and Statistics Unit at The Institute of Cancer Research, London, UK.
Background: Prostate cancer is a very prevalent disease in men. Patients are monitored regularly during and after treatment with repeated assessment of prostate-specific antigen (PSA) levels. Prognosis of localised prostate cancer is generally good after treatment, and the risk of having a recurrence is usually estimated based on factors measured at diagnosis.
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