[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"digestive-cancers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:digestive-cancers":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,74,102,126,158],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100635872","evaluation-of-the-clinical-impact-of-the-numerique-medical-device-maela-ont-the-care-pathway-in-digestive-oncology-surgery-100635872",false,"NCT07558330","Evaluation of the Clinical Impact of the Numerique Medical Device MAELA® Ont the Care Pathway in Digestive Oncology Surgery","CODAP","Inclusion Criteria:\n\n1. Patient aged 18 years and older\n2. Patient scheduled for digestive oncology surgery:\n\n   1. Colectomy for cancer\n   2. Pancreatectomy for cancer\n   3. Hepatectomy for cancer\n   4. Proctectomy for cancer\n   5. Gastrectomy for cancer\n   6. Esophagectomy for cancer\n3. At least 2 weeks between scheduling and surgery\n4. Patient with a smartphone (iOS or Android environment), or living with family members\u002Fprimary caregivers who have a smartphone with access to cellular data\u002FWi-Fi\n5. Subject affiliated with or beneficiary of a health insurance plan\n6. Subject who can read and understand French\n7. Subject who has signed informed consent\n\nExclusion Criteria:\n\n1. Patient already participating in an interventional clinical trial\n2. Adult patient subject to a legal protection measure, guardianship, or deprived of liberty by a judicial or administrative decision\n3. Patient unable to complete a questionnaire and without a close caregiver to support the use of the solution\n4. Patient with a psychiatric disorder that would prevent them from giving informed consent or receiving optimal treatment and follow-up\n5. Minor patient\n6. Visually impaired patient\n7. Patient with significant psychomotor disorders of the upper limbs\n8. Patient with memory disorders\n9. Patient without a mobile phone number\n10. Patient without internet access\n11. Pregnant or breastfeeding woman","ALL","18 Years",{"count":19,"type":20},555,"ESTIMATED","INTERVENTIONAL",[23],"NA","In France, digestive cancers are responsible for more than 40,000 deaths per year, or approximately 30% of cancer-related deaths.\n\nSurgery is central to the patient's journey, particularly their treatment, and postoperative complications, whether cardiovascular, respiratory, infectious, thromboembolic, or related to postoperative pain, remain common and can have a significant impact on patients' quality of life and long-term outcomes.\n\nThe implementation of continuous monitoring contributes to optimizing the care pathway and is necessary to improve postoperative outcomes.\n\nPostoperatively, remote monitoring has proven its effectiveness in significantly reducing postoperative readmission rates, particularly among patients who have undergone colorectal surgery.\n\nIt allows for rapid intervention in the event of frequent complications, thus preventing unnecessary hospitalizations.\n\nTo date, no study has evaluated the efficacy and safety of such a remote monitoring tool compared to conventional management on the clinical and organizational consequences postoperatively.\n\nMaela® is an app that allows patients to complete a symptom tracking questionnaire using a mobile device for 90 days following surgery. Surgeons can track new alerts via the solution's web interface.\n\nThe primary objective of the study is to evaluate the clinical efficacy of the Maela® medical remote monitoring device after elective digestive oncology surgery compared to conventional management.",[26],"Digestive Cancers",[28,29,30,31],"digestive cancer","Surgery","post-operative complication","remote monitoring","NOT_YET_RECRUITING","2026-04-23",{"date":35,"type":36},"2026-04-30","ACTUAL",{"date":38,"type":20},"2026-11-01",{"date":40,"type":20},"2027-11-01",{"name":42,"class":43},"Assistance Publique - Hôpitaux de Paris","OTHER",5,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100630625","benefits-of-early-collaboration-between-oncologists-and-palliative-care-physicians-in-cases-of-unplanned-hospitalization-for-patients-with-metastatic-cancer-100630625","NCT07490106","Benefits of Early Collaboration Between Oncologists and Palliative Care Physicians in Cases of Unplanned Hospitalization for Patients With Metastatic Cancer","SPPC","Inclusion Criteria:\n\n* Subjects aged 18 years and older;\n* Diagnosed with metastatic or locally advanced digestive, gynecological, ENT, or sarcoma cancer;\n* Currently undergoing systemic palliative treatment (no prospect of cure);\n* Hospitalized on an unscheduled basis (i.e., unplanned hospitalization for scheduled oncology treatments);\n* Patient covered by the French social security system;\n* Informed consent, written and signed.\n\nExclusion Criteria:\n\n* PS (WHO) = 4;\n* Patient receiving end-of-life care;\n* Patient opposed to the use of medical data for research purposes;\n* Person deprived of liberty or under guardianship;\n* Inability to undergo medical monitoring for the trial for geographical, social, or psychological reasons.",{"count":53,"type":20},493,[23],"This is a multicenter, national, interventional, cluster-randomized study, \"stepped wedge\" design. This study includes patients with metastatic or locally advanced digestive, gynecological, ENT, or sarcoma cancer, currently undergoing systemic palliative treatment and hospitalized on an unscheduled basis. The study will aim to evaluate the impact of early palliative care implementation for patients with metastatic or advanced cancer identified during an unplanned hospitalization.",[57,58,59,26,60,61],"Cancer","Sarcoma Metastatic","Gynaecologic Cancer","ENT Cancer","Metastatic Cancer or Locally Advanced",[63],"Metastatic or Locally Advanced digestive, gynecological, ENT, or sarcoma cancer","2026-03-19",{"date":66,"type":36},"2026-03-24",{"date":68,"type":20},"2026-04",{"date":70,"type":20},"2031-04",{"name":72,"class":43},"Centre Oscar Lambret",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":73},"100583820","impact-of-prior-identification-and-education-of-patients-requiring-a-digestive-stoma-for-fecal-diversion-100583820","NCT06881303","Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion","RESTODIG","Inclusion Criteria:\n\n* Men or women aged 18 and over\n* for whom a fecal diversion stoma is planned on a scheduled or emergency basis\n* affiliated with the French social security system\n\nExclusion Criteria:\n\n* Patient in a period of exclusion from another research protocol at the time of signing the no-objection form,\n* Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women),\n* No digestive stoma or fecal diversion planned\n* Person who does not understand French",{"count":82,"type":20},100,[23],"There are many indications for performing a fecal diversion stoma. In both scheduled and emergency situations, and whatever the context (indication or type of fecal diversion stoma), stomal complications can occur early (10-60%) or late (25%), and may require repeat surgery. The most frequent complications are necrosis, retraction, bleeding, evisceration, occlusion, abscess, hyperflow with hydroelectrolytic consequences, skin lesions, prolapse or eventration. What's more, a temporary stoma can become permanent.\n\nThe positioning and fabrication of the digestive stoma for fecal diversion must therefore comply with well-defined criteria to reduce the risk of stomal complications and the difficulties of fitting the stoma, and thus improve the autonomy and therefore the quality of life of the ostomate patient. The guide to good stoma therapy practice recommends that the site of the future stoma should be marked out preoperatively. What's more, the psychological impact of a stoma is such that preoperative and regular postoperative education is essential. This identification and initiation of education is carried out by stoma nurses and\u002For surgeons.\n\nThe impact of preoperative stoma identification and education on stoma complications, quality of life and patient autonomy has been reported in a few comparative series. The impact of preoperative education on quality of life has also been reported.\n\nHowever, despite this \"Evidence Based Medicine\", and the guide to good stoma therapy practice, the identification and education of the future fecal diversion stoma are not always carried out preoperatively. Reasons for this may include lack of time, lack of human resources, in the general context of a shrinking public hospital, or in the current context of distancing and dehumanization of the profession, or lack of conviction on the part of practitioners.\n\nTo this end, the investigators would like to propose a prospective observational study aimed at evaluating the impact of identification and education prior to the performance of a fecal diversion stoma in a programmed situation on the one hand, and an emergency situation on the other.\n\nThe main objective will be to compare quality of life specifically related to the stoma at 30 days postoperatively with the StomaQOL score, between 2 groups of patients:\n\n* unexposed group: no preoperative stoma identification and education\n* exposed group: preoperative stoma identification and education. This comparison will be stratified according to whether surgery is scheduled or emergency surgery.\n\nTotal 100 patients :\n\n* In scheduled surgery: 30 exposed and 30 unexposed patients\n* In emergency surgery: 10 exposed and 30 unexposed patients\n\nTimeline:\n\nInclusion period: 12 months Follow-up period: 12 months Total duration: 24 months",[86,87,88,89,90,91,26,92],"Colorectal Anastomosis","Endometrial","Anastomotic Leak Rectum","Ulcerative Colitis (Disorder)","Adenomatous Polyposis Coli, Familial","Crohn Disease","Protectomy","2025-11-17",{"date":95,"type":36},"2025-11-18",{"date":97,"type":20},"2026-03-01",{"date":99,"type":20},"2028-03-01",{"name":101,"class":43},"Assistance Publique Hopitaux De Marseille",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100602507","desir-evaluation-of-the-pre-therapeutic-activity-of-dihydropyrimidine-deshydrogenase-dpd-in-patients-with-cancer-andor-renal-failure-100602507","NCT07124403","DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and\u002For Renal Failure","Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and\u002For Renal Failure","DESIR","Inclusion Criteria:\n\n* Signed written informed consent\n* Affiliation to the Social Security System\n* Patients with breast or digestive cancer for whom a fluoroptmidine therapy is being considered\n* OR Patients on dialysis (GFR \\\u003C 10 ml\u002Fmin\u002F1.73 m²)\n* OR Nephrology patients with IR\n\nExclusion Criteria:\n\n* Patient with anemia \\\u003C 8.5 g\u002Fdl\n* Patient with LDH \\> 2 x \\> ULN\n* Legal incapacity or limited legal capacity\n* Subject without health insurance\n* Subject in the exclusion period of another study or in the \"national volunteer file\"",{"count":111,"type":20},742,"OBSERVATIONAL","Fluoropyrimidine drugs (5-Fluorouracil or 5-FU and its prodrug capecitabine) are a widely used in the treatment of numerous solid tumors in adults. Approximately 85% of administered 5-FU is rapidly catabolized in the liver into inactive dihydrofluorouracil (5-FUH2) by dihydro-pyrimidine dehydrogenase (DPD), leaving only a small fraction of the initial drug for an eventual transformation into cytotoxic metabolites. Impeded DPD activity is associated to an increase of cytotoxic metabolites leading to potentially very severe toxicities.\n\nTo prevent these toxicities, a pre-therapeutic measurement of plasma uracil can help assess DPD activity. Indeed, uracil is an endogenous substrate of DPD and an increase in its plasma concentration may be associated with a decrease in DPD activity. In this case, a reduction of the fluoropyrimidine dose is suggested.\n\nHowever, the investigators observed that uracilemia increased concomitantly to the severity of renal impairment. There are two possible explanations for this observation. Either the renal impairment reduces the renal elimination of uracil from blood, or DPD activity is actually impaired. In both cases, this can explain an increase in plasma uracil concentration.\n\nHowever, the impact on fluoropyrimidine dosage is different in the two cases. If the increase in uracilemia is due to renal impairment, DPD activity remains unaffected and there is no need to reduce the fluoropyrimidine dose. If DPD activity is actually impaired, a reduction in the fluoropyrimidine dose is required. In cases of renal impairment, uracilemia may therefore not be as relevant for DPD assessment as in the absence of renal impairment.\n\nTo assess if DPD activity is actually impede during renal impairment, the DPD activity of Peripheral Blood Mononuclear Cells (PBMCs) will be assessed together with uracilemia in patients with or without renal impairment. As uracilemia decreases after dialysis, the DPD activity of Peripheral Blood Mononuclear Cells (PBMCs) will also be assessed in patient before and after dialysis. Four groups of 50 patients will be studied: patients with normal renal function with hyperuracilemia (uracilemia ≥ 16 ng\u002FmL) or normal uracilemia (uracilemia \\\u003C 16 ng\u002FmL) ; and patients with renal impairment with hyperuracilemia (uracilemia ≥ 16 ng\u002FmL) or normal uracilemia (uracilemia \\\u003C 16 ng\u002FmL).\n\nThe main objective of the study is to describe the distribution of DPD activity in these four populations. The secondary objectives are to determine in normorenal patients the optimal threshold for DPD activity in non-deficient patients, allowing differentiation between deficient and non-deficient patients based on uracilemia ; and to describe in patients with impaired renal function the distribution of uracilemia with respect to the threshold previously described with the aim of verifying the relevance of uracilemia as a marker of DPD activity in such patients.",[115,26,116],"Renal Impairment","Breast Cancer","2025-09-11",{"date":119,"type":36},"2025-09-17",{"date":121,"type":20},"2025-09",{"date":123,"type":20},"2028-09",{"name":125,"class":43},"Centre Hospitalier Universitaire de Besancon",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":136,"conditions":137,"keywords":143,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100577829","somesthesia-in-cancer-patients-variability-and-influence-on-eating-experience-100577829","NCT06803381","Somesthesia in Cancer Patients: Variability and Influence on Eating Experience","SOMEST'ALIM2","Inclusion Criteria:\n\n* Patient between 18 and 70 years old\n* Patient with digestive, breast, gynecologic, ENT or lung cancer\n* Patient receiving a cancer treatment from at least two months\n* Patient having given his free, informed and express written consent\n\nExclusion Criteria:\n\n* Patient having a radiotherapy treatment for an ENT cancer\n* Patient with a known food allergy\u002Fintolerance to food samples (which may contain dairy products)\n* Patient unable to swallow soft food\n* Patient having presented nausea and vomiting during the last 24 hours\n* Patient with severe inflammation of the mouth or throat (ulcers, mucus)\n* Patient with cognitive disorders and memory loss\n* Pregnant women or breastfeeding\n* Adult under legal protection (guardianship)","70 Years",{"count":135,"type":20},96,"Patients with cancer are at high risk of denutrition, in France 39% of these patients suffer of malnutrition. This can affect the immunity, the mental balance and impact the treatment response and the quality of life.\n\nCancer treatments cause many side effects related to food intake as well as sensory alteration, important factor contributing to reduced appetite and inadequate food intake to cancer patients.\n\nSOMEST'ALIM2 is a prospective, non-randomized, monocentric, multisite study that aims to evaluate the appreciation of patients with different types of cancer (digestive, gynecological, breast, ear, nose and throat (ENT) or lung) of two different food versions (sweet and salty), in standard and enhanced version.\n\nPatients must be under treatment from at least two months, and before food testing their sensory capacity and quantity and the quality of their saliva will be tested. They will also be asked to answer to different questionnaires: socio-demographics, appreciation of food samples, self-assessment of oral symptoms and sensory perceptions, MD, Quality of Life Questionnaire (QLQ-C30) and food quality of life questionnaire.\n\nIn a context of sensory alterations patients should appreciate more the enhanced food versions. Patients perception of food will be evaluated using a visual analogue scale and results will be correlated with saliva characteristics, subjective sensory perceptions and oral symptoms.",[26,116,138,139,140,141,142],"Gynecologic Cancer","Lung Cancer","Nose Cancer","Throat Cancer","Ear Cancer",[57,144,145,146,147],"nutrition","somesthesia","food","perceptions","2025-02-04",{"date":150,"type":36},"2025-02-06",{"date":152,"type":20},"2025-03-13",{"date":154,"type":20},"2025-06-15",{"name":156,"class":43},"Hospices Civils de Lyon",2,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":166,"targetDuration":168,"studyType":112,"phases":4,"briefSummary":169,"conditions":170,"keywords":176,"overallStatus":185,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":73},"100570743","spanish-registry-of-digestive-tumours-retud-100570743","NCT06711211","Spanish Registry of Digestive Tumours RETUD","A Descriptive, Multicentre, Observational Epidemiological Study on Digestive Tumours","RETUD","Inclusion Criteria:\n\n* Male and female patients ≥18 years old diagnosed with oesophageal cancer, gastric cancer, pancreatic cancer, hepatocarcinoma, gallbladder and bile duct cancer, cancer of the small intestine, appendix and gastrointestinal stroma, colorectal cancer, anal canal cancer or digestive hereditary cancer.\n* Written informed consent available.\n\nExclusion Criteria:\n\n* Patient for whom, for whatever reason, it is not possible to know or obtain the information necessary to complete the data collection base.",{"count":167,"type":20},20000,"10 Years","The aim of this observational study is to assess the current state of digestive tumours in Spain. By doing so, it seeks to enhance the quality of care, optimize the diagnosis and treatment of digestive tumours, and identify opportunities for improvement that can benefit patients.\n\nThe study will investigate the epidemiological, biological, and clinical characteristics of digestive tumors diagnosed in patients aged 18 and older across healthcare centres in Spain. It also aims to generate knowledge and scientific evidence for events and situations that may impact on patients with digestive tumours (e.g. COVID-19 coronavirus pandemic).\n\nFurthermore, subject to the patient's consent, biological samples may be collected for use in translational research projects and for the identification of molecular markers that may be useful in healthcare decision-making.",[26,171,172,173,174,175],"Bile Duct Cancer","Hepatocellular Cancer (HCC)","Colorectal Cancer (CRC)","Pancreatic Cancer","Rectal Cancer",[177,178,179,180,181,182,183,184],"digestive","cancer","tumours","cholangiocarcinoma","hepatocellular","colorectal","pancreas","rectal","RECRUITING","2024-11-27",{"date":188,"type":36},"2024-12-02",{"date":190,"type":36},"2020-12-23",{"date":192,"type":20},"2030-12",{"name":194,"class":43},"Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)"]