[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Portuguese Oncology Institute, Coimbra\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100644619","integrated-early-care-for-head--neck-cancer-100644619",false,"NCT07671573","Integrated Early-CARE for Head & Neck Cancer.","Randomized Multicenter Clinical Trial of Early Integration of Palliative Care With Chemoradiotherapy Versus Chemoradiotherapy Alone in Patients With Locally Advanced Unresectable Head and Neck Cancer.","i-CARE-HN","Inclusion Criteria:\n\nEach patient must fulfil all of the following criteria:\n\n1. Diagnosis of locally advanced (unresectable) head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, larynx, and hypopharynx, staged according to the TNM AJCC 8th edition, proposed at a multidisciplinary team (MDT) meeting for definitive chemoradiotherapy (CRT) on an outpatient basis;\n2. Age ≥18 years;\n3. ECOG performance status 0-2;\n4. Adequate organ function: haemoglobin ≥9 g\u002FdL; neutrophils ≥1.5×10⁹\u002FL; platelets ≥100×10⁹\u002FL; creatinine ≤1.5×ULN; bilirubin, AST, ALT, LDH ≤1.5×ULN;\n5. Signed informed consent by the participant.\n\nExclusion Criteria:\n\nEach patient will be excluded if they meet any of the following criteria:\n\n1. ECOG performance status 3-4;\n2. Previous follow-up by specialised palliative care;\n3. Primary tumours of the nasopharynx, oesophagus, lip, or salivary glands;\n4. Metastatic head and neck cancer (oral cavity, oropharynx, larynx, and hypopharynx);\n5. Severe comorbidities: decompensated cardiovascular disease (NYHA class III\u002FIV heart failure, recent myocardial infarction), severe COPD (FEV₁ \\\u003C50% predicted), renal insufficiency (eGFR \\\u003C30 mL\u002Fmin), hepatic insufficiency (Child-Pugh B\u002FC);\n6. Laboratory values: neutrophils \\\u003C1.5×10⁹\u002FL, platelets \\\u003C100×10⁹\u002FL, haemoglobin \\\u003C9 g\u002FdL, creatinine \\>1.5×ULN;\n7. Diagnosis of dementia;\n8. Participation in another clinical trial.","ALL","18 Years",{"count":20,"type":21},64,"ESTIMATED","INTERVENTIONAL",[24],"NA","In Portugal, approximately 2,424 new cases of head and neck cancer are diagnosed each year, of which 60% are already at an advanced stage, presenting with intense pain and dysphagia (difficulty swallowing). There is also marked social isolation due to communication difficulties, economic hardship, and facial disfigurement (altered facial appearance). As a result, patients frequently face challenges in accessing specialised palliative care services, encountering delays, fragmentation, or a complete absence of such care.\n\nThe i-CARE-HN study is the solution: investigators aim to integrate outpatient palliative care with oncological treatment -namely chemoradiotherapy -at an earlier stage of the disease-when it is still limited to the throat and neck region, without metastasis (spread to other organs). This means multidisciplinary support from the outset of oncological treatment - symptom control, psychological support, and quality of life - without delaying the cure. It is like giving the patient a 'shield' against suffering, enabling them to complete treatment more efficiently.\n\nIn the i-CARE-HN study, early palliative care aims to better manage patients' symptoms (such as pain, difficulty speaking, swallowing, breathing, dry mouth, loss of appetite, and anxiety), to clarify doubts, to support therapeutic decisions, and to strengthen communication between the patient and the team, without replacing the primary oncological treatment. Rather than waiting for symptoms to worsen before seeking help, this support will be provided throughout treatment with chemotherapy and radiotherapy. Through this simultaneous integration of outpatient palliative care into oncological treatment, investigators hope to improve patients' symptoms and quality of life, as well as clinical outcomes: fewer treatment interruptions, improved treatment tolerability, fewer emergency hospitalisations, and greater overall survival. Investigators will want to know how patients are feeling throughout the process, and to that end, will invite them to complete a survey at several points during the study. Responses to the questionnaires are critical to enabling the medical team to rapidly identify which participating patients present with the most significant symptoms and the greatest risk of complications.\n\nThis study plans to recruit 64 patients aged 18 years or older, with a recent diagnosis of locally advanced, inoperable cancer, being followed on an outpatient basis at the IPO de Coimbra, IPO do Porto, and ULS de Coimbra, who will be invited to participate in the study. Should the patient agree to participate, some baseline data will be collected, and patients will subsequently be randomly assigned to one of two groups: one group will receive isolated chemoradiotherapy (standard treatment: cisplatin 100 mg\u002Fm² every 3 weeks- days 1, 22, and 49- and daily radiotherapy 70 Gy in 35 fractions over 7 weeks) and the other group will receive chemoradiotherapy alongside palliative care, on an outpatient basis (access to palliative care consultations). Patients randomised to the standard treatment group (chemoradiotherapy without a structured early palliative care intervention) will not have palliative care appointments systematically scheduled. However, should a referral to palliative care be requested, the patient may be directed to that clinical department.",[27,28,29],"Head & Neck Cancer","Locally Advanced Head and Neck Cancer","Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)",[31,32,33,34,35,36,37],"chemoradiotherapy","Cancer","Palliative care","Locally advanced Head and neck cancer","Squamous Cell Carcinoma of the Head and Neck","Edmonton Symptom Assessment System (ESAS)","Head and neck Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-06-25",{"date":41,"type":42},"2026-06-26","ACTUAL",{"date":44,"type":21},"2026-10-01",{"date":46,"type":21},"2028-03-31",{"name":48,"class":49},"Portuguese Oncology Institute, Coimbra","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":50},"100569589","to-evaluate-the-best-metric-for-inspection-time-during-a-diagnostic-andor-surveillance-upper-gastrointestinal-endoscopy-age--18-years-informed-consent-between-total-inspection-time-versus-withdrawal-time-for-the-identification-of-malignant-lesions-100569589","NCT06696209","To Evaluate the Best Metric for Inspection Time During a Diagnostic and\u002For Surveillance Upper Gastrointestinal Endoscopy (Age ≥ 18 Years, Informed Consent), Between Total Inspection Time Versus Withdrawal Time, for the Identification of Malignant Lesions","Analysis of Withdrawal Time in Upper Gastrointestinal Endoscopy as Procedure Time: a Randomised, Parallel, Double-blinded, Multicenter, International Clinical Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnostic or surveillance upper gastrointestinal endoscopy for premalignant conditions\n* Informed consent for the execution of the upper gastrointestinal endoscopy and participation in the study\n\nExclusion Criteria:\n\n* Previous esophagus, stomach, or duodenum surgery\n* Known or suspected neoplasia\n* Therapeutic procedure (polypectomy, argon plasma coagulation, hemostasis, others)",true,{"count":60,"type":21},1290,[24],"Gastric cancer is the fifth cause of cancer-related mortality worldwide. Gastric carcinogenesis involves the progression from premalignant conditions such as atrophic gastritis and intestinal metaplasia to premalignant lesions like dysplasia, and ultimately carcinoma. Most diagnoses of gastric cancer are made at advanced stages, with a five-year relative survival rate of 36%. Therefore, early detection of premalignant conditions and lesions is crucial, as it allows for timely surveillance and treatment, which can improve patient survival.\n\nUpper gastrointestinal endoscopy (UGE) is the first-line examination for diagnosing upper gastrointestinal tract pathology, particularly oncological conditions. The European Society of Gastrointestinal Endoscopy (ESGE) and the United European Gastroenterology (UEG) have established that UGE quality is a priority, identifying specific quality parameters, such as the duration of the procedure, which is the most extensively studied parameter.\n\nAccording to ESGE recommendations, all UGE reports should include the procedure time (goal: ≥90% of reports), which should be seven minutes or longer for surveillance of intestinal metaplasia. This time threshold follows a study that established a causal relationship between longer procedures (≥ seven minutes) and a higher detection rate of premalignant gastric conditions and lesions. Subsequent observational studies have generally shown that setting a minimum procedure time increases the detection rate of lesions.\n\nThe definition of procedure time varies between studies, being described as the time from intubation to extubation, but also as the time for withdrawing the endoscope from the second portion of the duodenum (D2) to extubation, also known as withdrawal time.\n\nThe hypothesis under study is that a better definition of the most appropriate time for a diagnostic UGE could standardize reports, improve malignant lesion detection rates, and reduce the rate of undiagnosed cancers, without any additional risk to patients.\n\nExisting studies have been retrospective or comparative between different temporal cohorts, with no prospective or randomised comparative studies, nor any studies comparing the two existing metrics. Therefore, the aim of this study is to evaluate the best metric for inspection time during a diagnostic and\u002For surveillance UGE, between total inspection time versus withdrawal time, for the identification of malignant lesions.",[64,65,66,67,68],"Premalignant Conditions","Malignant Lesions","Gastric","Esophageal","Duodenal","RECRUITING","2025-06-01",{"date":72,"type":42},"2025-06-04",{"date":74,"type":42},"2025-03-07",{"date":76,"type":21},"2026-01-01",{"name":48,"class":49},""]