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Background This paper describes the development of a Cancer Awareness Measure for colorectal (CRC) cancer (Bowel/Colorectal CAM a ) (study 1) and presents key results from a population-representative survey using the measure (study 2). Methods Study 1: Items were taken from the literature and reviewed by expert groups. A series of three validation studies assessed reliability and validity of the measure. To establish test-retest reliability, 49 people over 50 years of age completed the Bowel/Colorectal CAM on two occasions (range 9-14 days, mean 13.5 days). Construct validity was assessed by comparing responses from bowel cancer experts (n = 16) and the lay public (n = 35). Lastly, a brief intervention study tested sensitivity to change with participants (n = 70) randomly allocated to be given a control leaflet or an intervention leaflet and their responses were compared. Study 2: 1520 respondents completed the Bowel/Colorectal CAM in a population survey carried out by TNS-British Market Research Bureau International (TNS-BMRB) in March 2010. Results Study 1: Internal reliability (Cronbach's alpha = 0.84) was high. Test-retest reliability was over r = 0.7 for warning signs, risk factors and age people are first invited for screening, but lower (between 0.6 and 0.7) for other items (lifetime risk, awareness of bowel cancer screening, age at risk). Bowel cancer experts achieved higher scores than equally educated controls (54.7 [4.3] vs. 42.9 [5.7]; P < 0.001) demonstrating the measure has construct validity and intervention participants showed higher knowledge than controls (51.4 [5.9] vs. 42.9 [5.7]; P < 0.001) suggesting the measure is sensitive to change. Study 2: Respondents recalled on average, one CRC sign and one risk factor. There was particularly low prompted awareness of the signs 'lump in the abdomen' (64%) and 'tiredness' (50%) and several lifestyle risk factors for CRC, e.g. exercise (37%). Respondents from more affluent groups had consistently higher knowledge of signs and risk factors compared to those from more deprived groups. Conclusions The Bowel/Colorectal CAM meets accepted psychometric criteria for reliability and construct validity and should therefore provide a useful tool for assessment of CRC awareness. The population survey revealed low awareness of several CRC signs and risk factors and emphasises the importance of continuing public education, particularly about the link between lifestyle behaviours and CRC.

Cancer places a high burden on society and health-care systems. Cancer research requires high-quality data, which is resource-intensive to obtain. Using administrative datasets such as cancer registries could improve the efficiency of cancer studies if data were valid and timely. We aimed to compare the validity and timeliness of diagnostic cancer data on-site during the SYMPLIFY study to that obtained from the cancer registries of England and Wales. Cancer data were collected from 5461 participants across 44 hospital sites during a prospective observational study in England and Wales, SYMPLIFY (ISRCTN10226380). Linked cancer data were obtained from Digital Health and Care Wales (DHCW), the Welsh Cancer Intelligence and Surveillance Unit (WCISU), and the English National Cancer Registration Dataset (NCRD) and Rapid Cancer Registration Dataset (RCRD), regularly between April, 2022, and September, 2023. The primary objectives of the study were to evaluate the validity (via assessment of the proportion of completed data fields and concordance with SYMPLIFY sites), and timeliness of the data in all datasets, for all cancers diagnosed within 9 months of study enrolment. Data fields investigated were cancer site via International Classification of Disease, 10th Revision (ICD-10) code; cancer morphology via International Classification of Diseases for Oncology, 3rd Edition (ICD-O-3) morphology histology code and broad morphological grouping; overall stage; and TNM classification. For data collected between April, 2022, and September, 2023, completeness at the last data cut available for each dataset ranged from 84% to 100% for ICD-O-3 morphology, from 43% to 100% for overall stage, and from 74% to 83% for TNM stage. The concordance between SYMPLIFY data and NCRD was 96% (95% CI 92–98) for ICD-10, 60% (53–66) for ICD-O-3 morphology, 83% (78–88) for ICD-O-3 broad morphology groupings, 73% (67–78) for stage, and 51% (44–59) for TNM; and with WCISU was 89% (95% CI 81–94) for ICD-10, 63% (53–73) for ICD-O-3 morphology, 80% (70–87) for ICD-O-3 broad morphology groupings, 83% (74–90) for overall stage, and 49% (38–61) for TNM stage. Concordance between SYMPLIFY and RCRD was 95% (95% CI 92–98) for ICD-10, 67% (60–74) for ICD-O-3 morphology, 85% (79–90) for ICD-O-3 broad morphology groupings, and 73% (65–80) for overall stage; and between SYMPLIFY and DHCW was 96% (91–99) for ICD-10, 74% (64–83) for ICD-O-3 morphology, 84% (75–91) for ICD-O-3 broad morphology groupings, and 87% (74–95) for stage. The SYMPLIFY dataset reached completion at 12 months post-enrolment in November, 2022, compared with 13 months for NCRD in December, 2023. RCRD and DHCW reached completion at 13 months and 15 months post-enrolment, in December, 2022, and February, 2023, respectively. We report similar completeness of data fields, concordance, and timeliness between on-site and centrally collected cancer outcomes data. Our findings suggest that central registry data can help alleviate the resource burden in clinical trials and improve cancer research. Cancer registries might need additional resources to provide data for registry-based trials at scale. GRAIL Bio UK.

The UK Food Standards Agency (FSA) convened an international group of scientific experts to review three Agency-funded projects commissioned to provide evidence for the relative contributions of two sources, dietary vitamin D intake and skin exposure to UVB rays from sunlight, to vitamin D status. This review and other emerging evidence are intended to inform any future risk assessment undertaken by the Scientific Advisory Committee on Nutrition. Evidence was presented from randomised controlled trials to quantify the amount of vitamin D required to maintain a serum 25-hydroxy vitamin D (25OHD) concentration >25 nmol/l, a threshold that is regarded internationally as defining the risk of rickets and osteomalacia. Longitudinal evidence was also provided on summer sunlight exposure required to maintain 25OHD levels above this threshold in people living in the British Isles (latitude 51°–57°N). Data obtained from multi-level modelling of these longitudinal datasets showed that UVB exposure (i.e. season) was the major contributor to changes in 25OHD levels; this was a consistent finding in two Caucasian groups in the north and south of the UK, but was less apparent in the one group of British women of South Asian origin living in the south of the UK. The FSA-funded research suggested that the typical daily intake of vitamin D from food contributed less than UVB exposure to average year-round 25OHD levels in both Caucasian and Asian women. The low vitamin D status of Asian women has been acknowledged for some time, but the limited seasonal variation in Asian women is a novel finding. The Workshop also considered the dilemma of balancing the risks of vitamin D deficiency (from lack of skin exposure to sunlight in summer) and skin cancer (from excessive exposure to sunlight with concomitant sunburn and erythema). Cancer Research UK advises that individuals should stay below their personal sunburn threshold to minimise their skin cancer risk. The evidence suggests that vitamin D can be produced in summer at the latitude of the UK, with minimal risk of erythema and cell damage, by exposing the skin to sunlight for a short period at midday, when the intensity of UVB is at its daily peak. The implications of the new data were discussed in the context of dietary reference values for vitamin D for the general population aged 4–64 years. Future research suggestions included further analysis of the three FSA-funded studies as well as new research.

IntroductionMulti-cancer early detection (MCED) tests screen simultaneously for two or more cancer types using a biological specimen, e.g., blood. Modelling predicts that an MCED screening programme could reduce late-stage cancer incidence and cancer mortality. To realise these benefits, people with a ‘Cancer Signal Detected’ MCED test result need timely access to diagnostic testing and subsequent care. We estimate the likely shifts in demand for diagnostic endoscopy, imaging and other modalities relative to current national usage in England were MCED screening introduced in the future.MethodsWe modelled annual diagnostic demand using (1) estimates of the volume of people who would be referred for diagnostic investigation if an MCED screening programme was added to usual care in England, for adults aged 50–79 years (using the Galleri® MCED test [GRAIL, Inc., Menlo Park, CA, USA]), and (2) the distribution and accuracy of the predicted Cancer Signal Origin (CSO; the tissue type or organ predicted to be associated with the cancer signal) reported by the MCED test. A decision tree model was used to predict diagnostic activity by modality. We compared predicted usage with current total annual usage using routine NHS datasets, including the NHS Monthly Diagnostic Waiting Times and Activity data set for 2023–24.ResultsFollowing the initial introduction of MCED screening, we estimated an annual increase in usage of colonoscopy of 0.49% per million persons screened (equivalent to an additional ~3000 procedures, from 656k to 659k) and an increase in gastroscopy of 0.28% (~2000 additional procedures, from 723k to 725k). In an established MCED screening programme (steady state), the annual increase in usage attenuated to 0.16% for colonoscopy per million persons screened (~1000 additional procedures) and 0.10% for gastroscopy (~700 additional procedures). Of the diagnostic modalities examined, the largest relative increase in use was for endoscopy. This resulted from a large predicted number of gastrointestinal CSOs, due in part to a high test sensitivity for gastrointestinal cancers.ConclusionsOur modelling estimates that there is likely to be a small increase in demand for diagnostic endoscopy if an MCED screening programme is added to usual care in England. This increase is likely to persist to a lesser extent in the long term. The burden of meeting this additional demand would be shared between NHS Hospital Trusts across 21 Cancer Alliances in England. Our model captures only the immediate impact of MCED screening, and does not account for a future reduction in demand for endoscopy in symptomatic individuals because cancers are diagnosed before clinical presentation. NHS workforce and capacity planning should consider future developments in cancer screening, including the potential addition of a national MCED screening programme.

Estimates of the cost of cancer care are crucial for the economic evaluation of screening interventions and other early cancer diagnosis initiatives. However, data on the cost of cancer is scarce. This study estimated National Health Service (NHS) hospital care costs for eight cancer types by stage at diagnosis in England. This national, retrospective, population-based cohort study used individual patient-level data collated by the National Disease Registration Service, NHS England. We included patients aged 50–79 years who were diagnosed with a colorectal, head and neck, liver and bile duct, lung, lymphoma, oesophageal, ovarian, or pancreatic cancer in England between Jan 1, 2014, and Dec 31, 2017. For each patient, we obtained linked national health-care records, incorporating all inpatient hospital care, outpatient activity, and accident and emergency department attendances, and costed these using a payer perspective. Patients were excluded if registration was death certificate only, records related only to a secondary metastatic site, sex and cancer type were incompatible, death status or date were uncertain, or there were zero health-care costs from 6 months before diagnosis to end of follow-up. Net, cancer-related, regression-adjusted hospital care costs were reported for each cancer type and stage overall, annually, and by phase of care. Within each annual period and phase, mean monthly costs were also estimated. Of 359 106 cancer records registered, 345 629 cancers were available for analysis, and 333 657 cancers were included in the analysis (147 334 [44·2%] occurred in female patients and 186 323 [55·8%] in male patients; 303 227 [90·9%] among participants of White ethnicity, 4452 [1·3%] among participants of mixed or other ethnicity, 7870 [2·3%] among participants of Asian ethnicity, 4179 [1·3%] among participants of Black ethnicity, and 13 929 [4·2%] among participants of unknown ethnicity). Overall costs were higher at later stages for colorectal, head and neck, lymphoma, and ovarian cancers with mean stage IV costs of £37 838, £36 657, £42 667, and £45 871, respectively. Costs for liver and bile duct, lung, oesophageal, and pancreatic cancers were highest for those diagnosed at stage II (£28 356, £29 553, £33 640, and £39 351, respectively), and slightly lower at stages I, III, and IV. Health-care costs were highest in the initial treatment and the end-of-life phases of care. Within each phase, mean cost per month increased with stage for most cancer types studied, though fewer months of follow-up were observed in each phase for liver and bile duct, lung, oesophageal, and pancreatic cancers. Cancer-related NHS hospital care costs by stage at diagnosis differed between cancer types; this heterogeneous pattern could inform detailed and nuanced economic evaluations of early detection initiatives. GRAIL Bio UK.

Analysis of circulating tumour DNA could stratify cancer risk in symptomatic patients. We aimed to evaluate the performance of a methylation-based multicancer early detection (MCED) diagnostic test in symptomatic patients referred from primary care. We did a multicentre, prospective, observational study at National Health Service (NHS) hospital sites in England and Wales. Participants aged 18 or older referred with non-specific symptoms or symptoms potentially due to gynaecological, lung, or upper or lower gastrointestinal cancers were included and gave a blood sample when they attended for urgent investigation. Participants were excluded if they had a history of or had received treatment for an invasive or haematological malignancy diagnosed within the preceding 3 years, were taking cytotoxic or demethylating agents that might interfere with the test, or had participated in another study of a GRAIL MCED test. Patients were followed until diagnostic resolution or up to 9 months. Cell-free DNA was isolated and the MCED test performed blinded to the clinical outcome. MCED predictions were compared with the diagnosis obtained by standard care to establish the primary outcomes of overall positive and negative predictive value, sensitivity, and specificity. Outcomes were assessed in participants with a valid MCED test result and diagnostic resolution. SYMPLIFY is registered with ISRCTN (ISRCTN10226380) and has completed follow-up at all sites. 6238 participants were recruited between July 7 and Nov 30, 2021, across 44 hospital sites. 387 were excluded due to staff being unable to draw blood, sample errors, participant withdrawal, or identification of ineligibility after enrolment. Of 5851 clinically evaluable participants, 376 had no MCED test result and 14 had no information as to final diagnosis, resulting in 5461 included in the final cohort for analysis with an evaluable MCED test result and diagnostic outcome (368 [6·7%] with a cancer diagnosis and 5093 [93·3%] without a cancer diagnosis). The median age of participants was 61·9 years (IQR 53·4–73·0), 3609 (66·1%) were female and 1852 (33·9%) were male. The MCED test detected a cancer signal in 323 cases, in whom 244 cancer was diagnosed, yielding a positive predictive value of 75·5% (95% CI 70·5–80·1), negative predictive value of 97·6% (97·1–98·0), sensitivity of 66·3% (61·2–71·1), and specificity of 98·4% (98·1–98·8). Sensitivity increased with increasing age and cancer stage, from 24·2% (95% CI 16·0–34·1) in stage I to 95·3% (88·5–98·7) in stage IV. For cases in which a cancer signal was detected among patients with cancer, the MCED test's prediction of the site of origin was accurate in 84·8% (95% CI 79·5–89·0) of cases. Sensitivity 80·4% (95% CI 66·1–90·6) and negative predictive value 99·1% (98·2–99·6) were highest for patients with symptoms mandating investigation for upper gastrointestinal cancer. This first large-scale prospective evaluation of an MCED diagnostic test in a symptomatic population demonstrates the feasibility of using an MCED test to assist clinicians with decisions regarding urgency and route of referral from primary care. Our data provide the basis for a prospective, interventional study in patients presenting to primary care with non-specific signs and symptoms. GRAIL Bio UK.

The nature of cancer control is changing, with an increasing emphasis, fuelled by public and political demand, on prevention, early diagnosis, and patient experience during and after treatment. At the same time, primary care is increasingly promoted, by governments and health funders worldwide, as the preferred setting for most health care for reasons of increasing need, to stabilise health-care costs, and to accommodate patient preference for care close to home. It is timely, then, to consider how this expanding role for primary care can work for cancer control, which has long been dominated by highly technical interventions centred on treatment, and in which the contribution of primary care has been largely perceived as marginal. In this Commission, expert opinion from primary care and public health professionals with academic and clinical cancer expertise—from epidemiologists, psychologists, policy makers, and cancer specialists—has contributed to a detailed consideration of the evidence for cancer control provided in primary care and community care settings. Ranging from primary prevention to end-of-life care, the scope for new models of care is explored, and the actions needed to effect change are outlined. The strengths of primary care—its continuous, coordinated, and comprehensive care for individuals and families—are particularly evident in prevention and diagnosis, in shared follow-up and survivorship care, and in end-of-life care. A strong theme of integration of care runs throughout, and its elements (clinical, vertical, and functional) and the tools needed for integrated working are described in detail. All of this change, as it evolves, will need to be underpinned by new research and by continuing and shared multiprofessional development.