[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t-cells\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t-cells":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100470888","phase-2-a-phase-iia-randomized-double-blinded-clinical-trial-of-naproxen-or-aspirin-for-cancer-immune-interception-in-lynch-syndrome-100470888",false,"NCT05411718","A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome","Inclusion Criteria:\n\n* Participants must have Lynch syndrome defined as meeting any of the following:\n\n  1. \"Mutation-Positive Lynch syndrome\": carriers or obligate carriers (by pedigree) of a pathogenic mutation in one of the DNA mismatch repair (MMR) genes (i.e., MLH1, MSH2\u002FEPCAM, MSH6, or PMS2).\n  2. \"Mutation-Negative Lynch syndrome\": patients with a personal history of a non-sporadic MMR deficient premalignant lesion (i.e., polyp) or a non-sporadic MMR deficient malignant tumor (where \"non-sporadic MMR deficient\" is defined by: microsatellite-instability high by either immunohistochemistry or MSI testing or both, but no evidence of MLH1 promoter methylation in cases with loss of both MLH1 and PMS2, and\u002For no evidence of BRAF mutation in cases with loss of both MLH1 and PMS2) but germline MMR genetic testing showed either a variant of unknown significance or mutation negative result or had declined germline MMR genetic test-ing.\n* Participants must not have evidence of active\u002Frecurrent malignant disease for 6 months.\n* Participants must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or radiation).\n* Participants must have endoscopically accessible distal colon and\u002For rectal mucosa (i.e., partici-pants must have at least part of the descending\u002Fsigmoid colon and\u002For rectum intact).\n* Participants must consent to one standard of care lower GI endoscopy (flexible sigmoidoscopy or colonoscopy) with biopsies and one flexible sigmoidoscopy with biopsies that will be 12 months (+14 days) apart.\n* Participants must consent to refrain from using aspirin or NSAIDs or COX-inhibitors for the du-ration of the trial\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the long-term use of naproxen or aspirin in patients \\\u003C18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable.\n* ECOG performance status ≤1 OR Karnofsky ≥70%; see Appendix A.\n* Participants must have normal organ and marrow function as defined below:\n\nHemoglobin \\>10 g\u002FdL or Hematocrit \\> 30 % Leukocyte count ≥3,000\u002Fmicroliter Platelet count ≥100,000\u002Fmicroliter Absolute neutrophil count ≥1,500\u002Fmicroliter Creatinine ≤1.5 x institutional ULN (OR GFR \\>30ml\u002Fmin\u002F1.73m2) Total bilirubin ≤2 x institutional ULN AST (SGOT) ≤2.5 × institutional ULN ALT (SGPT) ≤2.5 × institutional ULN\n\n* The effects of naproxen on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because NSAIDs are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation. Should a woman become pregnant or suspect she is pregnant at the time of study entry or while participating in this study, she should inform her study physician immediately. Women of childbearing potential must agree to base-line and pre-drug pregnancy tests.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Willing and able to adhere to the prohibitions and restrictions specified in the final approved pro-tocol.\n* Willing to undergo yearly standard of care screening colonoscopy for the duration of the clinical trial.\n\nExclusion Criteria:\n\n* Individuals with presence of two somatic mutations\u002Floss of heterozygosity (LOH) in one of the four MMR genes (MLH1, MSH2, MSH6, and PMS2) in MMR-deficient neoplasm (defined as a tumor with MSI-H by PCR analysis or loss of staining in one of the four MMR proteins).\n* Individuals who received scheduled NSAIDs or COX-inhibitors of any kind for \\>3 days during anytime within the 2 weeks prior to baseline eligibility screening visit. By exception, individuals receiving cardio-protective aspirin (e.g., 81 mg PO daily) will be eligible provided they are will-ing to stop no less than 7 days prior to starting on naproxen or aspirin in this study.\n* Individuals who are status post total proctocolectomy (i.e., removal of all colon and rectum).\n* Individuals with active gastroduodenal ulcer disease in the preceding 5 years.\n* Individuals with any history of transfusion-dependent gastrointestinal bleeding, gastrointestinal perforation or gastrointestinal obstruction. If any of these events had been due to a malignancy of the GI tract and the malignancy has since been removed, the patient is eligible.\n* Individuals with history of myocardial infarction, stroke, coronary-artery bypass draft, invasive coronary revascularization in the preceding 5 years.\n* Individuals taking the drugs listed below may not be randomized unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less than 7 days prior to starting naproxen or aspirin on this study. Consultation with the participant's primary care provider may be obtained but is not required. The use of the following drugs or drug classes is prohibited during naproxen\u002Faspirin treatment:\n\n  * Investigational agents;\n  * NSAIDs: such as ketorolac, sulindac, ibuprofen, and others;\n  * COX-2 inhibitors: such as Celecoxib, Rofecoxib and other COX-2;\n  * Antiplatelet agents: such as aspirin, clopidogrel, ticlopidine, dipyridamole, abciximab, tirofi-ban, eptifibatide and prasugrel;\n  * Anticoagulants:\n\n    * Heparin;\n    * Heparinoids: such as fondaparinux, danaparoid and other heparinoids;\n    * Low-molecular weight heparins: such as enoxaparin, dalteparin, parnaparin, reviparin, tinzaparin, ardeparin, certoparin, lepidurin, bivalidurin;\n    * Other anticoagulants: argatroban, apixaban, dabigatran, rivaroxaban, warfarin, aceno-coumarol, dicumarol, phenindione and other anticoagulants;\n  * Lithium;\n  * Selective serotonin and norepinephrine reuptake inhibitors: minalcipran, fluoxetine, paroxe-tine, nefazadine, citalopram, clovoxamine, escitalopram, flesinoxan, femoxitene, duloxetine, venlafaxine, vilazodone, sibutramine, desvenlafaxine;\n  * Anticonvulsants: phenytoin, parakdehyde, valproic acid, carbamazepine, trimethadione, phenobarbital, diazepam, chlormethiazole, mephenytoin, ethotoin, paramethadione, phenac-emide, mephobarbital, oxcarbazepine, zonisamide, piracetam, vigabatrin, felbamate, gabapentin, beclamide, phosphenytoin, stripentol, tiagabine, topiramate, pregabalin, lacosa-mide, rufinamide, caramiphen;\n  * Antibiotics and antifungals:\n\n    o Fluorquinolones: such as ofloxacin, norfloxacin, levofloxacin;\n  * Other agents: teriflunomide, cyclosporine, tacrolimus, ginkgo, gossypol, meadowsweet, fe-verfew, beta glucan, pentosan, pentoxifylline, cilostazol, erlotinib, pemetrexed, methotrex-ate, pralatrexate.\n* Individuals with uncontrolled renal insufficiency or renal failure.\n* History of allergic reactions attributed to naproxen or aspirin.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncon-trolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac ar-rhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study require-ments.\n* Pregnant, breast-feeding, or women of childbearing potential unwilling to use a reliable contra-ceptive method. Pregnant women are excluded from this study because Naproxen\u002FNSAIDs is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with naproxen or aspirin, breastfeeding should be discontinued if the mother is treated with naproxen.\n\nInclusion of Women and Minorities:\n\n-Participants will be adult men and women of all races and ethnic groups, who are at least 18 years old, and who are deemed eligible for this trial. Children will not be recruited to the trial.\n\nOur minority recruitment strategies will include identifying participants through the University of Texas MD Anderson Cancer Center Familial High-Risk Gastrointestinal Cancer Clinic and Weill Cornell Med-ical College. We will advertise the study on minority and other national websites.","ALL","18 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","To learn about the effects of naproxen and aspirin on the normal colon in people with Lynch Syndrome.",[25,26,27],"T Cells","Colorectal Cancer","Lynch Syndrome","RECRUITING","2026-05-28",{"date":31,"type":32},"2026-06-01","ACTUAL",{"date":34,"type":32},"2023-03-21",{"date":36,"type":19},"2026-11-30",{"name":38,"class":39},"M.D. Anderson Cancer Center","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":40},"100583449","study-of-the-cellular-response-induced-after-vaccination-against-the-hepatitis-b-virus-100583449","NCT06876467","Study of the Cellular Response Induced After Vaccination Against the Hepatitis B Virus","Etude de la réponse Cellulaire Induite Post-vaccination Contre le Virus de l'hépatite B","HBVax","Inclusion Criteria:\n\n* Adults ≥18 years\n* Pre-vaccination HBV serology carried out within 4 weeks prior to vaccination\n* Collection of no objection\n\nExclusion Criteria:\n\n* Opposition of the person or inability to give opposition\n* Pregnant or breast-feeding women\n* Chronic illnesses affecting the individual's immune system (asplenia; hyposplenia; haematological cancer; auto-immune disease requiring immunosuppressive treatment, HIV infection).\n* Non-affiliation with a social security scheme, Universal Medical Coverage or any equivalent scheme",true,{"count":51,"type":19},115,"OBSERVATIONAL","296 million people worldwide are infected with the hepatitis B virus (HBV), despite the existence of an effective prophylactic vaccine. Current treatments (nucleoside analogues and pegylated interferon-α) do not prevent chronic hepatitis B (CHB) patients from developing liver fibrosis or hepatocellular carcinoma.\n\nVaccination is the best way to prevent HBV infection. The first generation of plasma-based vaccines, introduced in the 1980s, has now been superseded by protein vaccines, which are the only ones authorized in France. They are safe and effective. After an initial series of three out of four doses, protective levels of antibodies to the HBV surface antigen (anti-HBsAg; ≥10 IU\u002FmL) are achieved in over 95% of infants, children and young adults.\n\nHBV antigen (Ag)-specific CD4+ and CD8+ T lymphocytes play a major role in the control of HBV infection, contributing to viral clearance and the pathophysiology of acute hepatitis B. However, during HBC, these HBV-specific T cells develop a dysfunctional phenotype and become 'exhausted'. T lymphocytes directed against surface protein antigens (HBsAg) are the most affected by depletion mechanisms - these disappear completely in chronically infected patients, suggesting an important role for these T lymphocytes in infection control. Interestingly, recent studies of rare patients undergoing functional recovery from chronic infection following antiviral treatment have shown a re-emergence of T lymphocytes directed against HBsAg, confirming the importance of these cells in controlling viral replication. Although the protection induced by hepatitis B vaccination has mainly been attributed to the humoral response, a few studies have documented the presence of HBsAg-specific T lymphocytes. These could contribute to the maintenance of a long-term post-vaccination humoral response. The aim of this study is therefore to determine the frequency of healthy individuals receiving HBV vaccination who have a detectable HBsAg-specific T-cell response post-vaccination. We will also study the potential correlation between the frequency of HBsAg-specific T lymphocytes and the level of serum anti-HBsAg antibodies, and we will finely characterize the functional phenotype of these cells using cutting-edge methods and technologies (spectral cytometry, sequencing of mRNA and TCRs). These data will contribute to a better understanding of the biological mechanisms associated with HBV vaccine-induced protection.",[55,56,25],"Hepatitis B Vaccination","Immune Response",[58,59,60,61],"PBMCs isolation","Serology","Spectral cytometry","RNA sequencing","2026-04-22",{"date":64,"type":32},"2026-04-23",{"date":66,"type":32},"2025-08-11",{"date":68,"type":19},"2028-12-11",{"name":70,"class":39},"Assistance Publique - Hôpitaux de Paris",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":20,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":40},"100621807","will-a-pre-therapy-exercise-intervention-improve-the-outcomes-of-patients-with-advanced-oesophageal-cancer-100621807","NCT07375420","Will a Pre-therapy Exercise Intervention Improve the Outcomes of Patients With Advanced Oesophageal Cancer?","Optimising Prehabilitation Exercise to Enhance Tumour Outcomes in Advanced Oesophageal Cancer","OPTIMUS","Inclusion Criteria:\n\n* Adults with resectable oesophageal adenocarcinoma who are planned for neoadjuvant chemotherapy followed by surgery\n\nExclusion Criteria:\n\n* Inability to carry out CPET or exercise due to underlying health conditions\n* pregnancy\n* \\\u003C18 years old",{"count":80,"type":19},50,[82],"NA","Background\n\nRegular exercise can significantly improve physical and mental health during cancer treatment and reduce the time needed in the hospital. Animal studies suggest that exercise training can also reduce the number of cancer cells. For example, exercise training in mice produces more immune cells in the tumour. These immune cells in the tumour contribute to the destruction and reduction of the size of the tumour and are a vital component of effective immunotherapy (cancer treatment that helps the immune system fight cancer).\n\nIn humans, exercise training and the immune response in tumours are less understood. Only 1 study has investigated the effect of a single exercise session before surgical removal of the prostate in prostate cancer patients. As the benefits of exercise are gained from weeks\u002Fmonths of exercise, no effect on the immune cells in the tumours were found.\n\nThe investigators have carried out a previous study looking at how exercise affects fitness before major surgery. After this they used state-of-the-art methods to detect and visualise immune cells within the tumour. Compared with the patients who did not exercise, the exercise group had significantly more immune cells in their tumours, consisting of a group of cells that are important for killing cancerous cells called CD8+ T cells. CD8+ T cells in tumours are associated with improved survival outcomes.\n\nImportantly, they found a link between changes in fitness and the amount of these cells in the tumour. This suggests that if there is increase in fitness, there also an increase in the frequency of these cells in the tumour. Therefore, the investigators propose performing a clinical trial to find out the best level of exercise patients need to sustain before surgery to produce this improved immune response.\n\nThe trial will aim to understand how this happens and how the entry of immune cells into the tumour changes the environment around a tumour. The investigators consist of a team of exercise immunologists, tumour immunologists and clinicians working with the Human Performance Institute at the University of Surrey in collaboration with the Royal Surrey NHS Trust.\n\nHow it will be done\n\nThe investigators will assess immune cell response in blood samples obtained from oesophageal cancer patients before, during and after a high or low intensity exercise programme. Following the exercise programme, tumour tissue removed at surgery from these patients will be used to investigate the the presence and quantity of these immune cells.\n\nPotential impact\n\nA better understanding of this is important, as current anti-cancer immune-based therapeutics work best when there is a an immune response within the patient's tumour. Generating evidence that exercise can improve the immune response against the tumour in patients with oesophageal cancer would provide significant justification for introducing \"personalised\" exercise programmes to improve treatment outcomes.",[85,25,86,87],"Oesophageal Adenocarcinoma","Tumor Microenvironment","Exercise",[89,90,91],"oesophageal cancer","exercise","tumour microenvironment","2026-01-29",{"date":94,"type":32},"2026-02-02",{"date":96,"type":32},"2024-04-26",{"date":98,"type":19},"2028-10-30",{"name":100,"class":39},"University of Surrey"]