[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,58],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":38,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100574403","phase-2-total-neoadjuvant-therapy-and-organ-preservation-versus-surgery-for-rectal-cancer-100574403",false,"NCT06758830","Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer.","Total Neoadjuvant Therapy for Rectal Cancer - a New Standard of Care?","Part One\n\nInclusion Criteria:\n\n* Over 18 years of age.\n* Participants who agreed to participate in the study signed an informed consent form.\n* The Eastern Cooperative Oncology Group (ECOG) score ranges from 0 to 2.\n* Pathologically confirmed rectal adenocarcinoma.\n* Tumor up to 10 cm from the anus.\n* Magnetic resonance imaging (MRI) of the pelvis and computed tomography (CT) of the thorax and abdomen were performed to confirm the diagnosis.\n* cT1N1, T2-T3 N0 - 1, M0, MRF -, EMVI -.\n* Normal bone marrow function: blood leucocytes \\> 3.5 × 10⁹\u002Fl, neutrophils \\> 1.5 × 10⁹\u002Fl, platelets \\> 100 × 10⁹\u002Fl.\n* Normal renal function: creatinine within 1,5 × normal.\n* Normal liver function: blood bilirubin levels within 1,5 times normal, AST, ALT levels within 2,5 times the upper limit.\n\nExclusion Criteria:\n\n* Prior ST or Ch.\n* Participants who are not eligible for pelvic MRI.\n* Participants who have had a malignancy in the last 5 years, except for treatment for basal cell or squamous cell skin cancer or in situ cervical cancer.\n* ECOG status ≥ 3.\n* Distant metastases detected.\n* Participants with uncontrolled therapeutic or psychiatric conditions.\n* Infectious diseases requiring antibiotic treatment.\n\nPart Two\n\nInclusion Criteria:\n\n* Over 18 years of age.\n* Participants who agreed to participate in the study signed an informed consent form.\n* ECOG score between 0 and 2.\n* Pathological confirmed rectal adenocarcinoma.\n* Stage I to III rectal cancer confirmed.\n* The tumor is localized up to 12 cm from the anus.\n* Participants who refused to participate in the first part of the study or did not meet the inclusion criteria for the first part.\n* Participants have received preoperative CRT or TNT or are in the planning stages of neoadjuvant treatment.\n\nExclusion Criteria:\n\n* New cancer two years after CRT.\n* Stage IV cancer before treatment.\n* Participants refusing to participate in the study or unable to sign the informed consent.","ALL","18 Years",{"count":19,"type":20},400,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This study hypothesizes that approximately 50% of rectal cancer patients can preserve their rectum using a watch-and-wait strategy if they achieve a complete or near-complete clinical response to total neoadjuvant therapy (TNT). The objective is to determine whether the complications, quality of life, and survival rates of rectal cancer patients who have achieved a complete or near-complete clinical response to TNT, followed by a watch-and-wait approach, are comparable to those of patients who undergo surgery first. Additionally, the study aims to identify potential prognostic and predictive markers for rectal cancer and examine survival rates and factors influencing responses to chemoradiotherapy (CRT) or TNT.\n\nThe study is divided into two parts:\n\n\\*\\*Part One:\\*\\* Participants with cT1N1, T2-T3 N0-1 rectal cancer, MRF-, and EMVI-, with surgery as one of the possible first-line treatment options, will be randomized into two groups. The experimental group will consist of participants receiving TNT, including CRT and consolidation chemotherapy (Ch). If these participants achieve a complete or near-complete clinical response, they will be observed using a watch-and-wait strategy, which is a non-operative approach. The control group will consist of participants who undergo surgical treatment initially.\n\n\\*\\*Part Two:\\*\\* All participants with rectal cancer who have received CRT or TNT will be included. Additionally, participants diagnosed with rectal cancer who are scheduled for CRT or TNT but declined to participate in Part One or do not meet the inclusion criteria will also be included.",[27,28,29,30,31,32,33,34,35,36,37],"Rectal Cancer","Total Neoadjuvant Treatment","Neoadjuvant Therapy","Radiotherapy","Chemotherapy","Organ Preservation","Radiotherapy Side Effect","Chemotherapy Side Effects","Chemoradiotherapy","Low Anterior Resection Syndrome","Quality of Life",[39,28,40,30,31,35,32,33,41,42,43,44,36],"Rectal cancer","Neoadjuvant therapy","Chemotherapy side effects","Quality of Lifte","Fatigue","Postoperative complications","RECRUITING","2026-05-06",{"date":48,"type":49},"2026-05-11","ACTUAL",{"date":51,"type":49},"2025-01-06",{"date":53,"type":20},"2029-12-27",{"name":55,"class":56},"National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos","OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":5},"100555554","pathogenesis-of-postoperative-infections-and-biomarkers-for-early-diagnosis-of-it-100555554","NCT06513598","Pathogenesis of Postoperative Infections and Biomarkers for Early Diagnosis of it","New Studies of the Pathogenesis of Postoperative Infections and Development of Biomarkers for Early Diagnosis of Postoperative Complications","Inclusion Criteria:\n\n1. The patient is scheduled to undergo a major resection-type abdominal surgery due to cancer of the esophagus, stomach, pancreas, liver, bile ducts, colon or rectum.\n2. Patient is willing to participate.\n3. Age ≥ 18 years.\n\nExclusion Criteria:\n\n1. Pregnancy.\n2. Previous surgical resection of the digestive tract, excluding appendectomy and\u002For cholecystectomy.\n3. Anticipated operation with preventive ileostomy.\n4. The operation is planned to be performed as a matter of urgency.\n5. Antibiotic therapy ≤1 month. before surgery.\n6. Chronic inflammatory bowel disease (non-specific ulcerative colitis, Crohn's disease) or radiation or other colitis of origin.\n7. During the last year, the patient suffered from Cl. difficile colitis or was Cl. difficile carrier, had salmonellosis or others intestinal infections.\n8. During the last year, the patient used (\\> 3 months) pre-\u002Fpro-\u002F(syn)biotics.\n9. During the last year, the patient has been taking proton pump inhibitors continuously (\\> 6 months).",true,{"count":67,"type":20},200,"OBSERVATIONAL","Infections remain a prevalent complication after major abdominal surgery. The common belief that most surgical site infections (SSIs) following elective surgery with modern antiseptic techniques are due to intraoperative contamination is still not confirmed. Therefore, alternative mechanisms for SSI development, such as the Trojan Horse theory-which suggests that pathogens from distant sites like the gastrointestinal tract may cause postoperative infections-should be explored. This study aims to analyze the preoperative microbiome of surgical patients' gut and oral cavities and assess whether microorganisms found there are present at the infection site. Additionally, this study will investigate a panel of biomarkers for predicting postoperative infections.",[71,72],"Complication of Surgical Procedure","Infections",[74,75,76,77,78],"microbiota","surgical oncology","gastrointestinal cancer","postoperative complications","biomarkers","2024-07-30",{"date":81,"type":49},"2024-08-01",{"date":83,"type":49},"2024-07-01",{"date":85,"type":20},"2029-05-01",{"name":55,"class":56},""]