[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pten\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pten":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100615786","pten-and-organ-specific-micrornas-in-metastatic-breast-cancer-100615786",false,"NCT07297134","PTEN and Organ-Specific microRNAs in Metastatic Breast Cancer","Serum PTEN Levels and Organ-Specific microRNA Signatures as Predictors of Metastatic Patterns in Breast Cancer: A Prospective Observational Study","PTEN-miR-MBC","Inclusion Criteria:\n\n* Female individuals aged ≥18 years\n* Ability to provide written informed consent\n* Group I (Metastatic BC): Histopathologically confirmed breast cancer and radiologically or clinically proven distant organ metastasis at the time of enrollment\n* Group II (Non-Metastatic BC): Histopathologically confirmed breast cancer with no evidence of distant metastasis\n* Group III (Healthy Controls): Women ≥18 years with no known breast disease and no personal history of malignancy\n\nExclusion Criteria:\n\n* History of any other primary malignancy\n* Known breast disease or breast cancer diagnosis in Group III\n* Immunosuppressive therapy that may alter immune or biomarker profiles\n* Active infection or inflammatory condition that may alter biomarker levels\n* Inability or unwillingness to provide informed consent\n* Severe hepatic, renal, or hematologic dysfunction\n* Current pregnancy or lactation",true,"FEMALE","18 Years",{"count":21,"type":22},160,"ESTIMATED","OBSERVATIONAL","This prospective observational study aims to evaluate serum levels of PTEN, a tumor suppressor gene, and organ-specific microRNAs (miRNAs) associated with metastatic patterns in breast cancer. Serum samples will be analyzed using quantitative reverse transcription polymerase chain reaction (qRT-PCR)-based miRNA profiling and enzyme-linked immunosorbent assay (ELISA)-based PTEN quantification. Three groups will be included: patients with metastatic breast cancer (n=80), patients with non-metastatic early-stage breast cancer (n=40), and healthy controls (n=40).\n\nThe primary objective is to identify serum biomarkers that differentiate metastatic from non-metastatic disease. Secondary analyses will evaluate correlations between biomarker levels and organ-specific metastatic involvement, including bone, lung, liver, and brain metastases. Findings from this study may support the development of a noninvasive serum-based tool for predicting metastatic patterns in breast cancer.",[26,27,28,29],"Breast Cancer","Metastatic Breast Cancer","miRNAs","PTEN",[26,27,28,29,31,32,33],"Breast Cancer Biomarkers","Organ Specific Metastasis","miRNA Profiling","RECRUITING","2026-01-26",{"date":37,"type":38},"2026-01-27","ACTUAL",{"date":40,"type":38},"2025-12-01",{"date":42,"type":22},"2026-12",{"name":44,"class":45},"Atlas University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":17,"sex":53,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":74,"locationsCount":76},"100244520","natural-history-study-of-individuals-with-autism-and-germline-heterozygous-pten-mutations-100244520","NCT02461446","Natural History Study of Individuals With Autism and Germline Heterozygous PTEN Mutations","Inclusion Criteria\n\n* Individuals above the age of 18 months old at the time of consent who have documentation of a clinical diagnosis of autism spectrum disorder and\u002For a verified PTEN mutation from a medical or mental health professional for inclusion in the PTEN ASD, PTEN no-ASD or ASD macrocephaly groups.\n* Macrocephaly (head circumference greater than or equal to 98th percentile) for inclusion in the ASD macrocephaly group.\n* For youths, consent from parents or legal guardian. For adults, consent from self or legal guardian.\n* Youths who are able (some young or severely impaired participants may not be able to provide assent) will be asked to provide assent as per IRB guidelines.\n* Families with multiple children who meet the above inclusion criteria will be permitted to have as many children participate as they wish. A separate consent form will be filled out for each child enrolled in the study.\n* Primary communicative language must be English\n\nExclusion Criteria\n\n* Unwilling or unable to comply with study procedures and assessments\n* Clinically significant medical disease that would prohibit participation in the study procedures.\n* For subjects ELIGIBLE FOR OPTIONAL imaging biomarker assessment: contraindications to 3T MRI scanning, such as metal implants\u002Fnon-compatible medical devices or medical conditions, including vagus nerve stimulator.\n* For subjects ELIGIBLE FOR EEG\u002FERP biomarker assessment: contraindications to EEG\u002FERP, such as uncooperative or destructive behaviors preventing lead placement or capture by ERP\u002FVEP equipment. Under age 2 or over 11 at the time of enrollment.","ALL","18 Months",{"count":56,"type":22},170,"The purpose of this study is to determine cross-sectional and longitudinal medical, behavioral, and cognitive differences between PTEN ASD and other groups, as well as to identify cognitive, neural systems, and molecular biomarkers specific to PTEN ASD. In addition, this study will be creating and maintaining a biorepository and linked phenotypic database for PTEN ASD.",[29,59,60,61,62],"ASD","Autism","Macrocephaly","PTEN Hamartoma Tumor Syndrome",[64,65,66,59,60,61,62,29,67],"germline heterozygous PTEN mutations","MRI","10q23.3","EEG","2024-10-24",{"date":70,"type":38},"2024-10-26",{"date":72,"type":4},"2015-05",{"date":42,"type":22},{"name":75,"class":45},"Boston Children's Hospital",5]