[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Gene Solutions\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":177},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,79,105,130,151],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100533585","analysis-of-pd-l1-tmb-msi-and-ctdna-dynamics-to-predict-and-monitor-response-to-immunotherapy-in-metastatic-cancer-100533585",false,"NCT06227728","Analysis of PD-L1, TMB, MSI and ctDNA Dynamics to Predict and Monitor Response to Immunotherapy in Metastatic Cancer.","Analysis of PD-L1, TMB, CTDNA in Immunotherapy Response Monitoring and Prediction in Advancer Lung Cancer Treatment.","PTC-IMPACT","Inclusion Criteria:\n\n* 18 years and older, both genders.\n* Patients are diagnosed with stage IV cancer (lung, colorectal, breast, liver, gastric…) and indicated for ICI (first or second line). Concurrent chemotherapy with ICI is allowed.\n* FFPE\u002FFNA sample is available.\n* Compliant with treatment protocol.\n* Patients consented to participate in the study.\n\nExclusion Criteria:\n\n* Patients already started ICI before enrollment.\n* Consolidation ICI (eg. Durvalumab).\n* Patients already started chemotherapy before enrollment.\n* Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol.\n* Patients did not agree to participate in the studies.","ALL","18 Years","80 Years",{"count":21,"type":22},50,"ESTIMATED","3 Years","OBSERVATIONAL","This is an observational clinical trial, aiming to investigate whether the ctDNA dynamics could predict early response to ICIs in patients with advanced-stage cancer. Moreover, conventional tumor markers PD-L1, TMB and MSI are to be investigated for their combined prognostic values in ICI treatment.",[27,28,29,30,31,32,33],"Non Small Cell Lung Cancer","Breast Cancer","Colorectal Cancer","Gastric Cancer","Liver Cancer","Advanced Cancer","Immune Checkpoint Inhibitor","RECRUITING","2026-01-14",{"date":37,"type":38},"2026-01-16","ACTUAL",{"date":40,"type":38},"2024-03-22",{"date":42,"type":22},"2026-12-31",{"name":44,"class":45},"Gene Solutions","INDUSTRY",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100522784","predicting-breast-cancer-response-to-neoadjuvant-therapy-by-ctdna-assessment-100522784","NCT06087120","Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment","Investigate the Prognostic and Predictive Value of Circulating Tumor DNA (ctDNA) During Neoadjuvant Chemotherapy for Breast Cancer.","BRAVA","Inclusion Criteria:\n\n* Female,18 years old and older,\n* Are diagnosed with stage II-III HER2+\u002FTriple Negative breast cancer and indicated for neoadjuvant chemotherapy,\n* FFPE sample is available at the time of diagnosis and operation,\n* Are voluntary to participate in the study.\n\nExclusion Criteria:\n\n* Recurrent breast cancer,\n* Other cancer metastasis to the breast,\n* Have been or are being treated for cancer,\n* Patients did not agree to participate in the studies.","FEMALE",{"count":57,"type":22},125,"This is a prospective and observational study, aiming to determine the detection rate and change of CtDNA in blood samples of cancer patients before, during and after neoadjuvant treatment.\n\n* Determine the rate of ctDNA positivity at the time before treatment,\n* Determine the rate of ctDNA positivity at the time during treatment,\n* Determine the rate of ctDNA positivity at the time after neoadjuvant therapy, whether there is a change in ctDNA expression of the study population during treatment.\n\nAnd aiming to investigate the relationship between ctDNA expression and MRI imaging with pCR response in neo-adjuvant therapy:\n\n* Correlation between ctDNA detection and pCR response. Determine the percentage of Positive Prediction Value - PPV, Negative Prediction Value - NPV of ctDNA,\n* Correlation between MRI imaging and pCR response. Determination of PPV, NPV of MRI\n* Combination of ctDNA detection and MRI imaging in the prognosis of pCR. Determination of PPV, NPV ratio of ctDNA combined with MRI.",[60,61,62,63,64],"Breast Cancer Female","Stage II Breast Cancer","Stage III Breast Cancer","HER2-positive Breast Cancer","Triple Negative Breast Cancer",[66,67,68,69],"Liquid Biopsy","Circulating Tumour DNA","Vietnam","Indonesia","2025-09-18",{"date":72,"type":38},"2025-09-23",{"date":74,"type":38},"2023-09-16",{"date":76,"type":22},"2025-12-31",{"name":44,"class":45},3,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":19,"enrollmentInfo":87,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100602677","validation-of-the-spot-mas-lung-test-using-circulating-tumor-dna-for-the-detection-of-lung-cancer-100602677","NCT07126626","Validation of the SPOT-MAS Lung Test Using Circulating Tumor DNA for the Detection of Lung Cancer","Multi-center Prospective Validation of the SPOT-MAS Lung Test Using Circulating Tumor DNA for the Detection of Lung Cancer","Inclusion Criteria:\n\nCohort A\n\n1. Volunteers (participants) aged 50-80 years at the time of consent.\n\n   1. 50% smokers with a smoking history of 20 pack-years who currently smoke or have quit within the past 15 years.\n   2. 50% never-smokers or light smokers (\\\u003C 20 pack-years or quit \\> 15 years) who are first- or second-degree relatives of LC patients.\n2. Willing to undergo LDCT\u002FNCCT of the chest for lung cancer screening.\n3. Willing to consent to an investigational blood draw during the index LDCT\u002FNCCT screening visit and before any invasive procedures or treatment for lung cancer diagnosis.\n4. Willing to consent to a 1-year follow-up and additional follow-ups as per protocol.\n\nCohort B\n\n1. Subjects aged 50-80 years at the time of consent.\n\n   1. 50% smokers with a smoking history of 20 pack-years who currently smoke or have quit within the past 15 years.\n   2. 50% never-smokers or light smokers (\\\u003C 20 pack-years or quit \\> 15 years) who are first- or second-degree relatives of LC patients.\n2. Have undergone LDCT\u002FNCCT of the chest for lung cancer screening\u002Fdiagnosis, including only high-risk lesions (LUNG-RADS 4).\n3. Willing to consent to an investigational blood draw before any invasive procedures (CECT\u002FPET-CT\u002Fbiopsy) or treatment for lung cancer diagnosis.\n4. Willing to consent to a 1-year follow-up and additional follow-ups as per protocol.\n\nExclusion Criteria for both Cohort A and Cohort B\n\n1. Subject has a health problem that substantially limits life expectancy and\u002For the ability or willingness to have curative lung surgery.\n2. Subject is undergoing CECT for investigation of highly suspicious symptoms for lung cancer.\n3. Pre-existing or history of lung cancer.\n4. History of any malignancy (subjects who have undergone surgical removal of skin squamous cell cancer may be enrolled provided the procedure was completed at least 12 months prior to the date of provision of informed consent for the study).\n5. Currently taking any anti-neoplastic or disease-modifying anti-rheumatic drugs.\n6. Currently receiving treatment for pneumonia.\n7. Any major physical trauma (e.g., disruption of tissue, surgery, organ transplant, blood product transfusion) within the 30 days leading up to the provision of informed consent.\n8. Known medical condition which, in the opinion of the investigator, should preclude enrollment into the study.\n9. Participation in a clinical research study in which an experimental medication and\u002For medical procedure has been administered or may be administered within the 30 days leading up to providing informed consent or may be administered through the time of subject screening.\n\n   \\-\n\n   Exclusion Criteria:\n\n   \\-","50 Years",{"count":88,"type":22},1184,"This is an observational clinical trial, aiming to evaluate the efficacy of the SPOTMAS LUNG (SML) test compared to Low dose CTScan (LDCT)\u002FNone contrast CTScan (NCCT) in two distinct risk populations:\n\n* Cohort A: To demonstrate that SML is concordant with LDCT\u002FNCCT in general population lung cancer screening, including low-risk (LRs0-1-2), intermediate-risk (LRs3), and high-risk (LRs4) groups.\n* Cohort B: To validate the sensitivity and specificity of SML in the high-risk group (LRs4).",[91,92],"Lung Diseases","Lung Cancer Screening",[94],"SPOT-MAS Lung Test","NOT_YET_RECRUITING","2025-08-10",{"date":98,"type":38},"2025-08-17",{"date":100,"type":22},"2025-08-18",{"date":102,"type":22},"2027-07-31",{"name":44,"class":45},1,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":113,"targetDuration":115,"studyType":24,"phases":4,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":104},"100587555","assessing-systemic-treatment-and-ctdna-monitoring-efficacy-in-metastatic-cancer-patients-using-k4care-testing-100587555","NCT06929910","Assessing Systemic Treatment and ctDNA Monitoring Efficacy in Metastatic Cancer Patients Using K4Care Testing.","Evaluation of Systemic Therapy and the Effectiveness of Circulating Tumor DNA (ctDNA) Assays in Monitoring Treatment Response in Patients With Metastatic Cancer Undergoing K4Care Testing","GS_ZKM","Inclusion Criteria:\n\n* Pathological and imaging confirmation of metastatic or progressive stage IV cancer.\n* Consent to the use of their clinical data.\n* Diagnosis of one of the following common solid tumor types: lung, colorectal, breast, gastric, or cancer of unknown primary origin.\n* Prior K4Care testing to identify tumor tissue (FFPE) mutations and consent to the use of their sequencing data.\n\nExclusion Criteria:\n\n* Refusal to participate in the study.\n* Absence of prior K4Care testing.\n* Diagnosis of early-stage cancer or hematologic malignancy.\n* Refusal to provide clinical information or blood samples.",{"count":114,"type":22},200,"12 Months","The goal of this observational study is to investigate the real-world treatment landscape of patients with metastatic cancer and determine the role of ctDNA in monitoring treatment response in patients with metastatic cancer who have undergone K4Care testing",[118],"Metastatic Cancers",[120,121],"ctDNA","metastatic cancer","2025-07-12",{"date":124,"type":38},"2025-07-16",{"date":126,"type":38},"2025-04-09",{"date":128,"type":22},"2027-06-30",{"name":44,"class":45},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":137,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":138,"conditions":139,"keywords":144,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":104},"100528952","analysis-of-circulating-tumor-dna-dynamics-to-predict-and-monitor-response-to-tki-in-patients-with-advanced-nsclc-100528952","NCT06167460","Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.","Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to Tyrosine Kinase Inhibitors in Patients With Advanced Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed.\n* FFPE\u002FFNA sample is available.\n* Compliant with treatment protocol.\n* Patients consented to participate in the study.\n\nExclusion Criteria:\n\n* Patients already started TKI before enrollment.\n* Patients already started chemotherapy before enrollment.\n* Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol.\n* Patients did not agree to participate in the studies.",{"count":21,"type":22},"This is an observational study, aiming to investigate whether the ctDNA dynamics analyzed by the K-TrackTM assay could predict early response to Tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC).\n\n1. Determine relationship between ctDNA dynamics and clinical response to TKI,\n\n   * No response\u002Fprogressive disease = ctDNA levels increase from baseline\n   * Partial response\u002Fstable disease = ctDNA levels decrease from baseline\n   * Complete response = ctDNA clearance.\n2. Compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.\n3. Determine relationship between ctDNA dynamics and progression free survival, overall survival.",[27,140,141,142,143],"Stage IIIB Non-small Cell Lung Cancer","Stage IIIC Non-Small Cell Lung Cancer","Stage IV Non-small Cell Lung Cancer","Tyrosine Kinase Inhibitors",[66,67,68],{"date":124,"type":38},{"date":147,"type":38},"2023-12-04",{"date":149,"type":22},"2025-12-01",{"name":44,"class":45},{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":158,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":160,"conditions":161,"keywords":165,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":104},"100561378","ctdna-monitoring-to-predict-the-efficacy-of-tnt-for-rectal-cancer-100561378","NCT06589388","ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer","ctDNA Monitoring to Predict the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer","Inclusion Criteria:\n\n* 18 years and older, both genders\n* Patients are diagnosed with stage II-III rectal cancer and indicated for total neoadjuvant therapy\n* Biopsy FFPE sample is available at the time of diagnosis\n* Patients consented to participate in the study\n\nExclusion Criteria:\n\n* Stage I rectal cancer, recurrent or metastatic cancer\n* Other cancer metastasis to the rectum\n* Patients are indicated for chemoradiation therapy only\n* Have been or are being treated for cancer\n* Patients do not agree to participate in the studies.",{"count":159,"type":22},100,"This is a prospective observational study with three primary objectives:\n\nObjective 1: Evaluate the detection rate and changes in circulating tumor DNA (ctDNA) levels in blood samples from colorectal cancer patients before, during, and after total neoadjuvant therapy (TNT).\n\nDetermine the detection rate and change of CtDNA in blood samples of cancer patients before, during, and after TNT then assess changes in ctDNA expression within the study population during treatment.\n\n* Determine the ctDNA positivity rate before treatment.\n* Determine the ctDNA positivity rate during TNT.\n* Determine the ctDNA positivity rate after TNT and assess ctDNA level changes during treatment.\n\nObjective 2: Investigate the relationship between ctDNA expression and MRI\u002FCT scan imaging with the pathological complete response (pCR) to neoadjuvant therapy :\n\n* Correlation between ctDNA detection and pCR\u002FTRG\u002FNAR score. Calculate the Positive Prediction Value - PPV, Negative Prediction Value - NPV of ctDNA,\n* Correlation between MRI\u002FCT scan imaging and pCR. Calculate the PPV and NPV of MRI\u002FCT scan\n* Combination of ctDNA detection and MRI\u002FCT scan imaging to predict pCR. Calculate the PPV and NPV of the combined markers.\n\nObjective 3: Evaluate the relationship between post-TNT ctDNA expression and disease-free survival in colorectal cancer patients.",[162,163,164],"Rectal Cancer","Rectal Cancer Stage II","Rectal Cancer Stage III",[166,167,68,168],"liquid biopsy","circulating tumor DNA","total neoadjuvant therapy","2024-09-05",{"date":171,"type":38},"2024-09-19",{"date":173,"type":38},"2024-05-21",{"date":175,"type":22},"2027-12",{"name":44,"class":45},""]