Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-02 @ 9:04 AM
Study NCT ID:
NCT06845618
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}, {'id': 'D000092225', 'term': 'Tuberculosis, Extrapulmonary'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Biological specimens will be collected, processed, stored and shipped in concordance with established standard operating procedures. Blood will be collected following best practice venepuncture technique. Blood samples will be transferred by vehicle to the main SMRU laboratory in a cool box within six hours.\n\nThe leftover blood samples will be stored and may be used for future studies for up to 30 years. Anonymised samples may be shared with collaborators internationally for further analysis. Consent will be obtained from participants for sample storage and future use of specimen. Any proposed plans to use samples other than for those investigations detailed in this protocol will be submitted to the relevant ethics committees prior to any testing.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-02-19', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mtb-cfDNA trajectories', 'timeFrame': 'Day 0 - 168 (or end of treatment)', 'description': 'Rate of Mtb-cfDNA clearance derived from serial Mtb-cfDNA measurements'}, {'measure': 'Percentage of participants completing sampling schedule', 'timeFrame': 'Day 0 - 168 (or end of treatment)'}], 'secondaryOutcomes': [{'measure': 'Exploratory analysis is planned and will compare Mtb-cfDNA levels to clinical, microbiological and radiological features', 'timeFrame': 'Day 0 - 168 (or end of treatment)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cfDNA'], 'conditions': ['Mycobacterium Tuberculosis', 'Tuberculosis, Pulmonary', 'Tuberculosis, Extra-Pulmonary']}, 'descriptionModule': {'briefSummary': 'Tuberculosis (TB) is a leading infectious cause of death worldwide. Current strategies for monitoring TB treatment response are culture dependent and insensitive. New methods of assessing treatment response in vivo could inform new drug development and other treatment strategies. Cell-free DNA (cfDNA) - small circulating fragments of DNA - is widely used in maternofetal medicine and oncology for diagnosis and assessment of treatment response. This study aims to investigate whether pathogen derived Mycobacterium tuberculosis-specific cfDNA (Mtb-cfDNA) can be used to monitor TB treatment response.\n\nThis feasibility study will take place at Mae RaMat TB Center in Thailand and includes two study groups:\n\n1. Assay Development and Validation\n2. Longitudinal Assessment of Mtb-cfDNA levels', 'detailedDescription': 'This study is funded by the Wellcome Trust; grant reference number: 223099/Z/21/Z'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Group 1: Assay development and validation. In this group, sampling will be performed at tuberculosis diagnosis. Tuberculosis participants (n = 20) will have blood sampling performed at day 0. Healthy participants (n = 20) without clinical evidence of tuberculosis will have blood sampling performed at a single timepoint.\n\nGroup 2: Longitudinal Assessment. In this group, tuberculosis participants (n= 120) will have longitudinal sampling performed from diagnosis to the end of treatment. This will help to establish the feasibility of dynamic Mtb-cfDNA measurements.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants with a new diagnosis of tuberculosis\n\n* Aged ≥ 18 years old\n* Newly microbiologically confirmed (culture or nucleic acid amplification test) diagnosis of Mycobacterium tuberculosis (Mtb.) infection (of any site)\n* Has not yet commenced antituberculosis therapy\n* Able to understand study procedures and requirements and is able to give informed consent\n\nFor healthy volunteers:\n\n* Aged ≥ 18 years old\n* Healthy as judged by a responsible physician\n* Able to understand study procedures and requirements and is able to give informed consent\n\nExclusion Criteria:\n\nParticipants with a new diagnosis of tuberculosis\n\n* Exposure to antituberculosis treatment in the last 8 weeks (or Mycobacterium tuberculosis (Mtb.) active fluoroquinolone)\n* Known history of underlying malignancy\n* Pregnancy\n* Transfusion dependent anaemia\n\nFor healthy volunteers:\n\n* History of tuberculosis infection or latent tuberculosis infection\n* Household, or other close contact, of a person living with tuberculosis disease\n* Chest radiograph (CXR) changes suggestive of pulmonary tuberculosis\n* Presence of symptoms which would otherwise indicate screening for tuberculosis (cough \\> 2 weeks duration, fever, weight loss, night sweats)\n* Other major medical comorbidity\n* Pregnancy\n* Known malignancy'}, 'identificationModule': {'nctId': 'NCT06845618', 'acronym': 'Mtb-Dynamic', 'briefTitle': 'Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Mycobacterium Tuberculosis Complex Cell-free DNA (Mtb-cfDNA) for the Pharmacometric Assessment of Anti-tuberculosis Treatment: a Proof-of-concept Study', 'orgStudyIdInfo': {'id': 'MYC24003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: Assay development and validation', 'description': 'Twenty participants with a new diagnosis of tuberculosis will have venous blood collected prior to treatment initiation. Twenty participants without clinical evidence of tuberculosis infection will be recruited from the local community as a control during assay validation. This group of the study participants will be assessed at day zero only.'}, {'label': 'Group 2: Longitudinal Assessment', 'description': 'In this group, tuberculosis participants (n= 120) will have longitudinal sampling performed from diagnosis to the end of treatment. This will establish the feasibility of dynamic Mtb-cfDNA measurements for the assessment of tuberculosis treatment response.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tak', 'country': 'Thailand', 'contacts': [{'name': 'Htet Ko Ko Aung, Dr', 'role': 'CONTACT', 'email': 'htetkoko@shoklo-unit.com', 'phone': '055 581 135', 'phoneExt': '109'}, {'name': 'François Nosten, Professor', 'role': 'CONTACT', 'email': 'francois@tropmedres.ac', 'phone': '055 532026'}], 'facility': 'Shoklo Malaria Research Unit (SMRU)', 'geoPoint': {'lat': 16.86968, 'lon': 99.12898}}], 'centralContacts': [{'name': 'Htet Ko Ko Aung, Dr', 'role': 'CONTACT', 'email': 'htetkoko@shoklo-unit.com', 'phone': '055 581 135', 'phoneExt': '109'}, {'name': 'François Nosten, Professor', 'role': 'CONTACT', 'email': 'francois@tropmedres.ac', 'phone': '055 532026'}], 'overallOfficials': [{'name': 'Timothy Seers, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "The data generated in this study belongs to the study group as a whole. The final database will be shared amongst the PI and key members of the research team.\n\nWith participant's consent, clinical data and results from blood analyses stored in the database may be shared with researchers not directly involved in this study but only after the main paper has been published and in accordance with MORU guidelines on data sharing.\n\nThe results of the study will be summarised in lay language, in both English and the language(s) commonly spoken at the study site, and disseminated to participants and the community.\n\nThe Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study. Authorship will be determined in accordance with the International Committee of Medical Journal Editors (ICMJE) guidelines and other contributors will be acknowledged."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}