[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bone-metastasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bone-metastasis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,79,104],{"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":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100635520","plasma-exosomal-rna-signature-for-prostate-cancer-bone-metastasis-100635520",false,"NCT07553754","Plasma Exosomal RNA Signature for Prostate Cancer Bone Metastasis","Plasma Exosomal RNA Signature for Predicting PSMA PET-Defined Bone Metastasis in Prostate Cancer: A Prospective, Multicenter Discovery, Development, and Validation Study","EXO-MET","Inclusion Criteria\n\n1. Patients with histologically confirmed prostate cancer who are scheduled to undergo baseline PSMA PET imaging.\n2. Patients who undergo PSMA PET imaging prior to any prostate cancer-related treatment (including androgen deprivation therapy, radiotherapy, or surgery).\n3. Patients who provide blood samples for plasma exosomal RNA analysis collected prior to any treatment AND prior to prostate biopsy (if applicable).\n\n   Whole blood samples (approximately 10 mL) will be collected in EDTA tubes at this specified time point. Samples will be processed within 2 hours to obtain plasma and stored at -80°C until analysis.This timing ensures circulating exosomal RNA profiles reflect tumor biology without biopsy-induced contamination.\n4. Patients who are willing to undergo prostate biopsy if clinically indicated (biopsy performed after blood collection).\n5. Patients who provide written informed consent to participate in the study.\n6. Age ≥18 years.\n\nExclusion Criteria\n\n1. Patients who have received any prior prostate cancer-related treatment before the baseline PSMA PET scan (including hormonal therapy, radiotherapy, chemotherapy, or surgery).\n2. Patients whose blood samples were collected after prostate biopsy.\n3. Patients with a history of other active malignancies within the past two years (excluding non-melanoma skin cancer).\n4. Patients with inadequate blood sample quality or quantity for exosomal RNA extraction and analysis (e.g., hemolysis, insufficient volume \\\u003C8 mL).\n5. Patients with severe comorbidities or conditions that, in the judgment of the investigator, could interfere with study compliance or pose significant risk.","MALE","18 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","Brief Summary:\n\nThis prospective, multicenter study aims to discover, develop, and validate a plasma exosomal RNA-based signature as a rule-out test for predicting bone metastasis in prostate cancer, using baseline treatment-naïve PSMA PET as the gold standard. The study is designed in four sequential phases:\n\nPhase 1 (Discovery, n=250): High-throughput sequencing of plasma exosomal RNAs to identify differentially expressed candidate RNAs.\n\nPhase 2 (Model Development, n=300): Digital droplet PCR (ddPCR) analysis of candidates in an independent cohort to construct and lock the final multi-RNA predictive signature using appropriate machine learning methods.\n\nPhase 3 (Internal Validation, n=300): Independent validation of the locked signature in a consecutive cohort reflecting natural disease prevalence.\n\nPhase 4 (External Validation, n=150): Final independent validation in a multi-center cohort enriched for bone metastasis.\n\nPrimary Outcome:\n\nTo evaluate the diagnostic performance of the signature as a rule-out test for PSMA PET-defined bone metastasis. The primary performance metrics are:\n\nSensitivity, with a prespecified target of ≥95% (to ensure minimal false negatives).\n\nSpecificity at the threshold that achieves the ≥95% sensitivity. A specificity of ≥30% will be considered supportive of clinical utility. A specificity of ≥30% (or a lower bound of the 95% confidence interval exceeding 20%) will be considered supportive of clinical utility.\n\nNeed:\n\nCurrent biomarkers lack sensitivity and specificity for early detection of bone metastasis. More importantly, existing tools lack adequate negative predictive value to safely rule out bone metastasis in low-risk patients, leading to over-imaging or delayed detection. There is an urgent need for a non-invasive rule-out test to safely defer PSMA PET\u002FCT in very-low-risk patients. Plasma exosomal RNAs offer a promising liquid biopsy approach, but prospective multicenter studies with rigorous validation are lacking.\n\nSecondary Outcomes:\n\n1. Secondary metrics include negative predictive value (NPV), positive predictive value (PPV), area under the ROC curve (AUC), calibration, and decision curve analysis.\n2. Correlation between exosomal RNA levels and number of bone metastatic lesions (PSMA PET).\n3. Association with PSA, PSMA PET SUVmax, and MRI findings.\n4. Tissue-plasma correlation to confirm tumor origin (exploratory).\n5. Mechanistic exploration of key candidates via in vitro\u002Fin vivo assays (exploratory).\n6. Subgroup analyses by hormone sensitivity, metastatic pattern, Gleason grade (exploratory).\n\nInclusion Criteria:\n\n1. Histologically confirmed prostate cancer scheduled for baseline PSMA PET.\n2. PSMA PET performed prior to any prostate cancer-related treatment.\n3. Blood samples collected prior to any treatment AND prior to prostate biopsy.\n4. Willing to undergo prostate biopsy if clinically indicated (after blood collection).\n5. Written informed consent.\n6. Age ≥18 years.\n\nExclusion Criteria:\n\n1. Any prior prostate cancer treatment before baseline PSMA PET.\n2. Blood samples collected after prostate biopsy.\n3. Other active malignancy within past two years (excluding non-melanoma skin cancer).\n4. Inadequate blood sample quality or quantity.\n5. Severe comorbidities interfering with study conduct.",[25,26,27,28,29,30,31],"Prostate Cancer (Diagnosis)","Bone Metastasis","PSMA PET","Liquid Biopsy","Exosomal RNA","Biomarker Discovery and Validation","Treament-naive",[33,26,27,28,29,34],"Prostate Cancer","Predictive Signature","RECRUITING","2026-04-20",{"date":38,"type":39},"2026-04-28","ACTUAL",{"date":41,"type":39},"2026-03-12",{"date":43,"type":21},"2027-12-31",{"name":45,"class":46},"Xijing Hospital","OTHER",9,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":5},"100584053","spinal-palliation-in-irradiation-for-neoplastic-analgesia-and-life-quality-100584053","NCT06884332","Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality","Étude de Non infériorité Sur l'Impact de la Diminution Des Volumes d'Irradiations vertébraux en Cas d'Irradiation Palliative Rachidienne métastatique Osseuse Sur l'efficacité Antalgique","SPINAL","Inclusion Criteria:\n\n* Patient with bone pain related to at least 1 or more bone metastases of spinal location, contiguous or not, cervical (excluding C1), thoracic, lumbar or sacral up to and including S2; a patient can be included even if he or she is irradiated concomitantly or not for analgesic purposes on another non-spinal bone metastatic site. Bone lesions are objective on an imaging examination less than 3 months old: CT and\u002For MRI and\u002For PET and\u002For bone scintigraphy;\n* Patient with at least moderate pain with EN ≥ 5;\n* Patient on analgesic drug treatment for at least 7 days or poor tolerance of analgesics;\n* Patient irradiated for palliative analgesic purposes. Post-cementoplasty irradiation is possible; an extension to the soft tissues is not a contraindication to inclusion;\n* Patient with a validated palliative bone irradiation plan: 8 Gy \u002F 1 fr or 20 Gy \u002F 5 fr;\n* Patient with planning only in static IMRT, arc therapy or helical tomotherapy;\n* Patient with a primary cancer or a haemopathy;\n* Patient currently undergoing or not a specific oncological systemic treatment, left to the discretion of the investigating physician;\n* Patient currently undergoing or not a treatment with bisphosphonates and denosumab, left to the discretion of the investigating physician;\n* WHO ≤ 2;\n* Patient with a life expectancy ≥ 3 months;\n* Patient able and agreeing to follow all study procedures in accordance with the protocol;\n* Patient having understood, signed and dated the consent form;\n* Patient affiliated to the social security system.\n\nExclusion Criteria:\n\n* Pediatric patient;\n* Patient undergoing stereotaxic irradiation;\n* Patient undergoing oligometastatic disease;\n* Patient undergoing re-irradiation unless the dose is not limiting to OARs;\n* Patient treated with RT2D (conventional 2-dimensional radiotherapy) or RT3D (conventional 3-dimensional radiotherapy);\n* Patient with MESCC (metastatic epidural spinal cord compression) except for a Bilsky grade \\\u003C 1b;\n* Patient who does not have a means of responding to online questionnaires;\n* Patient and their entourage who cannot read or express themselves in French;\n* Visually impaired patient;\n* Patient already included in another therapeutic trial with an experimental molecule;\n* Persons deprived of liberty or under guardianship (including curatorship).\n* Pregnant woman, likely to be pregnant, or breastfeeding","ALL",{"count":58,"type":21},598,"INTERVENTIONAL",[61],"NA","The goal of this clinical trial is to assess the impact of reducing the volume of palliative metastatic bone irradiation on analgesic effectiveness at day 30 and to evaluate the efficiency of telemonitoring in identifying patients who could benefit from Patient-Reported Outcomes (PROs) and require care.\n\nThese objectives will be addressed in a multicenter, randomized, prospective study with two arms:\n\nA standard arm with spinal irradiation without sparing the adjacent vertebrae. An experimental arm with spinal irradiation sparing the adjacent vertebrae. The results will determine whether reducing the irradiated volume can maintain effective pain relief while minimizing side effects.",[26,64],"Oncology Pain",[66,67,68,69],"Bone metastasis","Irradiation","Palliative","Analgesic","2025-09-22",{"date":72,"type":39},"2025-09-23",{"date":74,"type":39},"2025-07-02",{"date":76,"type":21},"2029-01-02",{"name":78,"class":46},"Institut de Cancérologie de Lorraine",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":59,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100585532","phase-2-non-steroidal-anti-inflammatory-drugs-in-the-prevention-of-bone-pain-flares-after-palliative-radiotherapy-100585532","NCT06903585","Non Steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy","Non-steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 years or older\n* Primary Solid tumor (Any type of solid tumor)\n* Painful bone metastases which are otherwise uncomplicated (no fracture and no neurologic symptoms due to nerve impingement or compression)\n* Baseline pain score on a numeric rating scale (0-10) of at least 2\n* Stable dose and schedule of narcotic medications prescribed\n\nExclusion Criteria:\n\n* Hematologic malignancy\n* Previously irradiated bone\n* Current use of steroids\n* Current use of NSAIDs which cannot be stopped before randomization\n* Contraindications for NSAIDs (hypersensitivity, PUD, prior GI bleed, CKD, HTN, HF, AERD\u002Fasthma)\n* Contraindications for PPIs",{"count":87,"type":21},385,[89],"PHASE2","Solid tumors have the tendency to spread to other organs in around 26% of cases, with many cases involving the bone causing severe bone destruction and pain that reduces patients' quality of life. Palliative radiation therapy is used as a standard of care to decrease cancer-related bone pain, as it has been proven to provide pain relief in many patients, either partially or totally, within only a few weeks. However, some patients experience worsening of bone pain especially within the first 10 days after radiation therapy, this is called bone pain flare, and its incidence is estimated to be around 40%. This pain flare tends to further reduce these patients' quality of life considering their main illness, which necessitates its prevention or alleviation.\n\nNon-Steroidal Anti-inflammatory Drugs (NSAIDs) which are a key component of the World Health Organization (WHO) analgesic options used to alleviate cancer pain have not had a good share of published trials in the prevention of bone pain flares.\n\nIn this light the investigators aim to conduct a double-blinded, placebo-controlled randomized controlled trial to investigate the effectiveness of NSAIDs, specifically Proxen, in preventing bone pain flares after palliative radiotherapy, and as a secondary endpoint they will compare the quality of life and side effects experienced by patients in either group.",[92,26],"Bone Pain Flare","NOT_YET_RECRUITING","2025-04-01",{"date":96,"type":39},"2025-04-04",{"date":98,"type":21},"2025-04",{"date":100,"type":21},"2029-04",{"name":102,"class":46},"American University of Beirut Medical Center",1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":59,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":103},"100578066","biomolecular-markers-of-bone-metastasis-100578066","NCT06806462","Biomolecular Markers of Bone Metastasis","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Patients with breast or lung or renal or gastroenteric tract or prostate with bone metastases\n* Patients who knowingly express willingness to participate in the study after signing the written informed consent\n\nExclusion Criteria:\n\n* None",{"count":111,"type":21},160,[61],"The goal of this clinical trial is to characterize the biomolecular profile of bone metastases to define the predisposing profiles of bone metastasis, in patients with breast or lung or renal carcinomas or of the gastroenteric or prostate tract with bone metastasis.\n\nThe main question it aims to answer is:\n\nIs it possible to predict the progression of bone metastasis by identifying biomarkers as risk factors for bone metastasis?",[26],[116,117,118],"bone","metastasis","biomolecular profile","2025-01-28",{"date":121,"type":39},"2025-02-04",{"date":123,"type":39},"2024-09-17",{"date":125,"type":21},"2026-09-17",{"name":127,"class":46},"IRCCS Azienda Ospedaliero-Universitaria di Bologna"]