Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 2:53 PM
Study NCT ID:
NCT07422805
Status:
COMPLETED
Last Update Posted:
2026-02-24
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circulating Tumor DNA in Melanoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of ctDNA With Clinical and Histopathological Prognostic Parameters', 'timeFrame': 'Baseline and during follow-up up to 24 months', 'description': 'Circulating tumor DNA (ctDNA) will be measured in peripheral blood plasma using a validated molecular assay (e.g., digital droplet PCR and/or next-generation sequencing). ctDNA will be reported as detectable vs. non-detectable and as ctDNA concentration (copies/mL). Correlation between ctDNA results and clinical/histopathological prognostic parameters (e.g., AJCC stage, Breslow thickness, ulceration status, and metastatic status) will be assessed.'}], 'secondaryOutcomes': [{'measure': 'Recurrence or Progression of Melanoma', 'timeFrame': 'From baseline up to 24 months', 'description': 'Melanoma recurrence or disease progression will be assessed based on clinical evaluation and imaging findings documented in the medical record. The outcome will be reported as the proportion of participants with recurrence/progression and correlated with ctDNA detectability and ctDNA concentration (copies/mL).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Circulating Tumor DNA', 'ctDNA', 'Melanoma'], 'conditions': ['Melanoma', 'Skin Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective observational study is to determine whether the presence and quantity of circulating tumor DNA (ctDNA) can serve as a predictive factor for recurrence or progression of melanoma. The study will evaluate the association between ctDNA detection and quantification and relevant clinical and histopathological prognostic parameters. The goal is to assess whether ctDNA may be useful as a biomarker for monitoring disease course and predicting outcomes in melanoma patients.', 'detailedDescription': 'This is a prospective observational cohort study designed to evaluate the clinical significance of circulating tumor DNA (ctDNA) detection and quantification in patients with melanoma. The main purpose of the study is to determine whether the presence and quantity of ctDNA may represent a predictive biomarker for melanoma recurrence or disease progression.\n\nThe study will assess the relationship between ctDNA levels and established clinical and histopathological prognostic factors. ctDNA detection and quantification will be performed and correlated with relevant patient and tumor characteristics. The study will also evaluate whether ctDNA measurement can contribute to improved monitoring of melanoma patients and prediction of treatment outcomes.\n\nThe study is conducted at the Institute of Oncology Ljubljana as a prospective cohort study and includes melanoma patients who are followed over time. The collected data will be analyzed to determine associations between ctDNA presence/quantity and recurrence or progression of melanoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients (≥ 18 years).\n* Patients with histologically confirmed melanoma.\n* Patients undergoing treatment and/or follow-up at the Institute of Oncology Ljubljana.\n* Availability of clinical follow-up data to assess recurrence or progression.\n* Ability to provide blood samples for ctDNA analysis.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients unable to provide blood samples.\n* Patients with missing clinical or histopathological data required for analysis.\n* Any condition that, in the investigator's opinion, makes the patient unsuitable for participation."}, 'identificationModule': {'nctId': 'NCT07422805', 'acronym': 'ctDNA', 'briefTitle': 'Circulating Tumor DNA in Melanoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Oncology Ljubljana'}, 'officialTitle': 'Significance of Detection and Quantification of Circulating Tumor DNA in the Treatment of Melanoma Patients', 'orgStudyIdInfo': {'id': 'ORI2025-40'}, 'secondaryIdInfos': [{'id': 'ERIDEK-0084/2021', 'type': 'OTHER', 'domain': 'Institute of Oncology Ljubljana (ali Ethics Committee of the Institute of Oncology Ljubljana)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ctDNA Monitoring Cohort', 'description': 'Melanoma patients monitored for presence and quantity of circulating tumor DNA (ctDNA) during follow-up in order to evaluate its association with recurrence or progression of disease.', 'interventionNames': ['Other: Blood Sampling for ctDNA Analysis']}], 'interventions': [{'name': 'Blood Sampling for ctDNA Analysis', 'type': 'OTHER', 'description': 'Collection of peripheral blood samples for detection and quantification of circulating tumor DNA (ctDNA) and evaluation of its association with clinical outcomes in melanoma patients.', 'armGroupLabels': ['ctDNA Monitoring Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Institute of Oncology Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Oncology Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}