BackgroundSickle cell disease (SCD) accounts for 5% of mortality in African children aged < 5 years. Improving the care management and quality of life of patients with SCD requires a reliable diagnosis in resource-limited settings. We assessed the diagnostic accuracy of the rapid Sickle SCAN® point-of-care (POC) test for SCD used in field conditions in two West-African countries.MethodsWe conducted a case-control study in Bamako (Mali) and Lomé (Togo). Known cases of sickle cell disease (HbSS, HbSC), trait (HbAS), HbC heterozygotes (HbAC) and homozygous (HbCC), aged ≥6 months were compared to Controls (HbAA), recruited by convenience. All subjects received both an index rapid POC test and a gold standard (high-performance liquid chromatography in Bamako; capillary electrophoresis in Lomé). Personnel conducting tests were blinded from subjects’ SCD status. Sensitivity and specificity were calculated for each phenotype. Practicality was assessed by local healthcare professionals familiar with national diagnostic methods and their associated constraints.ResultsIn Togo, 209 Cases (45 HbAS, 39 HbAC, 41 HbSS, 44 HbSC and 40 HbCC phenotypes) were compared to 86 Controls (HbAA). 100% sensitivity and specificity were observed for AA Controls and HbCC cases. Estimated sensitivity was 97.7% [95% confidence interval: 88.0–99.9], 97.6% [87.1–99.9%], 95.6% [84.8–99.5%], and 94.9% [82.7–99.4], for HbSC, HbSS, HbAS, and HbAC, respectively. Specificity exceeded 99.2% for all phenotypes. Among 160 cases and 80 controls in Mali, rapid testing was 100% sensitive and specific. Rapid testing was well accepted by local healthcare professionals.ConclusionRapid POC testing is 100% accurate for homozygote healthy people and excellent (Togo) or perfect (Mali) for sickle cell trait and disease patients. In addition to its comparable diagnostic performance, this test is cheaper, easier to implement, and logistically more convenient than the current standard diagnostic methods in use. Its predictive value indicators and diagnostic accuracy in newborns should be further evaluated prior to implementation in large-scale screening programs in resource-limited settings where SCD is prevalent.
Advances in diagnosis and treatment have helped increase cure rates for many cancers. However, the disease and its treatments are often accompanied by short-, mid- and long-term organic and psychosocial sequelae and increased risk of second cancer, adding to that, all pre-existing comorbidities, lifestyle risks and hereditary factors. At the Centre Leon Berard Cancer center, we launched a project named PASCA (Parcours de Sante au cours du Cancer) that aims at structuring and optimizing a follow-up schedule for patients suffering from breast cancer, testicular germ tumor, acute leukemia, lymphoma or myeloma, as well as patients who received hematopoietic stem cell transplantations (HSCT). The main objective of the program is the early detection and specific management of risk factors for second cancer as well as sequelae management after the acute treatment phase with the final objective of quality of life improvement. Follow-up and evaluation are done through the establishment of a multidisciplinary organic assessment, anthropometric and physical fitness, psychic and socio-professional evaluation, the aim is to establish a score for each assessment, complementary to the specific oncology and hematology monitoring, that allows later to establish a personalized and adapted sequelae management and prevention of complications that could significantly impact the patient quality of life but also compromise the optimal management of the malignant disease. Patients were referred to PASCA by the oncologist/hematologist after being discharged from the acute phase of treatment, an information sheet about the program was given as well as a package containing different questionnaires to capture information about risk factors, general health, social status, quality of life and others. At the same time a series of medical laboratory requests were ordered to get a full medical assessment. Based on the questionnaires/medical evaluation a score was given for each type of assessment. Score 0 means the patients needs only a simple follow-up, score 1 means the patient needs to be followed by the family doctor for the specific issue, and score 2 means there is a need for specialist intervention. We put together a network of internal medicine or organ specific doctors in addition to fitness-physiotherapy specialist as well as many other specialists available to intervene for patients with score 2. We started in Hematology a pilot phase that included non-Hodgkin lymphomas (NHL, N=27) and multiple myelomas (MM, N=27) patients, 15 (28%) females and 39 (72%) males. Median age at evaluation was 60 years (range: 56-65), all patients except 8 (all NHL) received autologous HSCT. Here we present some of the most relevant PASCA assessments with the different scores: nephrology (0: 94%, 1:6%), cardiology (0:27%, 1:63%, 2:10%), hepatology (0:49%, 1:42%, 2:9%), pneumology (0:41%, 1:39%, 2:20%), sexual (0:67%, 1:14%, 2:9%), dermatology (0:78%, 1:13%, 2:9%), pain (0:43%, 1:31%, 2:26%), gynecology (0:56%, 2:44%), endocrinology (0:67%, 1:31%, 2:2%), malnutrition (0:75%, 1:8%, 2:17%), obesity (0:54%, 1:20%, 2:26%), flexibility (0:46%, 1:27%, 2:27%), employment (0:76%, 2:24%), fatigue (0:24%, 1:2%, 2:73%), anxiety (0:56%, 1:22%, 2:22%), and depression (0:80%, 1:10%, 2:10%). In addition, a list of FACT questionnaires was collected for all patients as baseline evaluation and will be compared later during follow-up. During the PASCA consult visit, patient was informed about his different assessment results and in case of any score 1 or 2, a referral to the family doctor or a specialist was requested. Planned 6- and 12-months evaluation are ongoing to evaluate the potential improvement after PASCA program. Our results from this pilot study showed a real need for specific follow-up on the medical level but also on social/well being level that is in most of the cases given less priority when the patient is seen in oncology/hematology clinic. We noticed a significant positive feedback from patients included in this program and we expect to see a drastic improvement on the medical, psychological and social level as well as on quality of life. We are starting the full PASCA program that will include also patients with breast cancers, germ cells cancers and sarcoma. A protocol for a randomized multicentric study is in preparation and will allow to evaluate the impact and the importance of such program in patients with malignant diseases. Disclosures No relevant conflicts of interest to declare.
Introduction In France, cancer incidence is increasing, reaching approximately 400,000 new cases in 2017. Thanks to diagnostic and therapeutic advances, net survival at 5 years is improving, with a corollary increase in the number of survivors. Among survivors, 44% have a poor quality of life due to the more or less late onset of treatment-related complications. Despite the objectives of the 2014-2019 national cancer plan considering the latest therapeutic advances, very few initiatives integrating systematic, early detection and management of complications exist in France. Methods and analysis PASCA (Care pathways through cancer) is a single-arm, interdisciplinary, prospective, interventional, cohort study. During a period of 24 months, it is intended to include 858 adults aged 18 to 65 years with non-Hodgkin and Hodgkin lymphoma, acute myeloid leukemia, testicular germ cell tumor, non-metastatic invasive breast cancer, soft tissue sarcoma, osteosarcoma or Ewing's sarcoma at Centre Leon Berard (Lyon, France). The program consists on exhaustive identification of 22 complications at 1 month, 6 months, 24 months and 60 months after the end of first line treatment: social precariousness, return-to-work issues, cognitive problems, anxiety and depression disorders, chronic fatigue, physical deconditioning, overweight/obesity, chronic pain, dermatological disorders, gastrointestinal disorders, sexual disorders, hypogonadism, premature ovarian failure, osteoporosis, chronic kidney failure, heart failure, coronary heart disease, respiratory failure, hypothyroidism, lymphedema, modifiable risk factors associated with the occurrence of secondary cancers. Each identification will give rise to management, which consists of referring the patient to a healthcare professional belonging to the network of dedicated healthcare professionals at the regional level. The course of action to be followed will be defined using decision trees based on international, national or learned society recommendations. Referral outside Centre Leon Berard will be made to a specialist doctor, a health professional from the paramedical field or the patient's general practitioner who will confirm the diagnosis and initiate patient management and follow-up. These patients will also benefit from their usual follow-up in the context of their initial malignancy. Each study visit will include a search for clinical signs using questionnaires, an assay of 12 biological parameters, a urine test strip, 5 tests evaluating physical deconditioning and an electrocardiogram. The weight, height, waist circumference, blood pressure will also be measured. Primary outcome will be the incidence of the 22 complications, measured at 1 month, 6 months, 24 months and 60 months after the end of intensive chemotherapy treatment. Ethics and dissemination The study protocol was approved by the French ethics committee (Comité de protection des personnes Ile de France IV), the study database is currently being declared and registered to the Commission Nationale de l'Informatique et des Libertés (CNIL) and the study on ClinicalTrials.gov. The results will be disseminated to patients and in peer-reviewed journals and academic conferences. Strengths and limitations of this study This study is based on a previous feasibility study with 52 patients recruited in onco-hematology, which demonstrated the feasibility of the intervention and the existence of patient management needs.(1) The study design does not include a comparator arm, as the objective of the study is to provide a comprehensive picture of treatment-related complications, especially those that appear over the long term. Due to the lack of recent data concerning some complications, sample size was calculated empirically on the basis of the active queue of patients at the Centre Leon Berard. References Michallet M, Sobh M, Buono R, Poirey S, Pascu I, Nicolas-Virelizier E, et al. Personalised Follow-up Program after Acute Phase of Treatment in Oncology/Hematology Patients Towards Early Intervention, Better Care and Quality of Life Improvement: Results from Pasca Pilot Study. Blood. 13 nov 2019;134(Supplement_1):5817-5817. Disclosures Nicolini: Sun Pharma Ltd: Consultancy; Incyte: Research Funding, Speakers Bureau; Novartis: Research Funding, Speakers Bureau.
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