Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-26 @ 4:37 AM
Study NCT ID:
NCT06291259
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mpox Prospective Observational Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045908', 'term': 'Mpox, Monkeypox'}], 'ancestors': [{'id': 'D011213', 'term': 'Poxviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018419', 'term': 'Primate Diseases'}, {'id': 'D000820', 'term': 'Animal Diseases'}, {'id': 'D012376', 'term': 'Rodent Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Acute phase:\n\n1. Blood\n2. Urine\n3. Nasopharyngeal swab\n4. Throat swab\n5. Rectal swab\n6. Semen sample or vaginal swab, as applicable\n7. Skin lesions (see below)\n8. Breastmilk, if lactating\n\nConvalescent phase:\n\n1. Rectal swab\n2. Semen sample/vaginal swab (as applicable)\n3. Breastmilk (if applicable).\n\nSamples are collected for testing of mpox PCR and serology.\n\nParticipants will be asked to consent to storage of these samples for future testing as well (e.g. biobanking)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of clinical manifestation', 'timeFrame': '12 weeks', 'description': 'Clinical manifestations of mpox infection during the Canadian outbreak, including symptom duration and spectrum, complications, natural history and sources of variability in clinical manifestations'}, {'measure': 'Psychosocial impact', 'timeFrame': '12 weeks', 'description': 'Describe the psychosocial impacts of mpox-related illness and isolation requirements, including financial insecurity, psychological distress and perceived and enacted stigma'}, {'measure': 'Transmission-related aspects of mpox infection', 'timeFrame': '12 weeks', 'description': 'Types and timing of human and animal contacts prior to mpox infection, as well as quantifying the detectability of mpox viral DNA in the immediate environment of people ultimately diagnosed with the infection, including physical surfaces and air samples'}, {'measure': 'Virologic aspects of mpox infection over time', 'timeFrame': '12 weeks', 'description': 'Detectability of mpox viral DNA by polymerase chain reaction (PCR) along with the associated cycle threshold, as well as titers of infectious virus, in different anatomic compartments and examining the viral genomic sequence. Outcomes also include characterizing the host response to mpox infection including host gene and cytokine expression and antibody titers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mpox'], 'conditions': ['Monkeypox']}, 'descriptionModule': {'briefSummary': "The goal of this multicentre prospective observational cohort study is to shed light on the following unknowns:\n\n1. The clinical manifestations of Mpox infection since the 2022 outbreak in Canada.\n2. The social and psychological impacts of Mpox infection since the 2022 outbreak in Canada\n3. The transmissibility of Mpox infection\n4. Viral shedding over time in infected individuals\n\nThe study is divided into Part 1 (corresponding to the acute phase of illness) and Part 2 (corresponding to the convalescent phase of the illness); part 2 will be optional. Participants enrolled during the acute phase of illness will complete part 1 of the study and will be invited to participate in Part 2 as well. Part 1 of the study will include the following three core components, at baseline and weekly (±3 days) until one week after the resolution of all symptoms (i.e. one week after complete healing of skin lesions):\n\n1. Collection of clinical data through chart review and research staff interviews with study participants\n2. Participant self-administered online questionnaires at baseline and a thrice-weekly 'acute phase participant diary'\n3. Specimen collection for Mpox-related testing Optional components for Part 1 include baseline-only, questionnaire-only, and frequent sampling.\n\nOther optional components for all participants include in the Image Atlas, an online database of clinical images of mpox, designed to provide clinicians and community members of what mpox looks like in real life, and the biobank, which will store research samples for potential future studies.", 'detailedDescription': 'Mpox is caused by a virus that normally infects animals (rodents, monkeys, and others), but can sometimes infect humans. In the past, it was usually only seen in a few specific countries, but since the beginning of May 2022 it has been reported in many other countries, including Canada, where it has never been seen before. The virus can cause several symptoms, including "flu-like" symptoms (fever, headache, feeling tired, muscle pains, swollen glands, sore throat) and skin symptoms (spots, bumps, blisters, open sores, scabs). However, sometimes it can also cause very few symptoms, or no symptoms at all. Mpox can be spread from one person to another in a few ways, such as directly touching the affected skin areas of someone who has the infection, touching sheets or clothes that were used by someone with the infection, or breathing in particles of virus that came from the nose, mouth and lungs of someone with the infection ("respiratory droplets").\n\nIn the cases seen around the world since May 2022, doctors and patients have noticed many things that are unusual for mpox infection. Some of these relate to the symptoms people have had (for example, the order in which people get different symptoms might be changing), and the ways in which it has been spread from person to person (for example, we do not know if it can be spread through sex). There is also worry that the infection could have bad effects on people\'s financial situation and emotional wellness, especially because people with mpox have to self-isolate at home for several days or weeks until the infection is completely over, to protect public health. Finally, there is also a lot that doctors and scientists still do not yet know about the virus itself, including the specific parts of the body where it can be found, the amount of time that it stays in those parts of the body, and its biology (e.g. its "genetic sequence" or genes).\n\nThe purpose of this study is to learn more about 1) the symptoms people have, 2) the ways mpox is spread, 3) the effects on people\'s lives, and 4) the virus itself, including the places in the body and surrounding environment where it can live. Canada is currently experiencing an outbreak and the outlined purposes are critical and relevant to clinical and public health control efforts.\n\nThe study is divided into Part 1 (corresponding to the acute phase of illness) and Part 2 (corresponding to the convalescent phase of the illness); part 2 will be optional. Participants enrolled during the acute phase of illness will complete part 1 of the study and will be invited to participate in Part 2 as well. Part 1 of the study will include the following three core components, at baseline and weekly (±3 days) until one week after the resolution of all symptoms (i.e. one week after complete healing of skin lesions):\n\n1. Collection of clinical data through chart review and research staff interviews with study participants\n2. Participant self-administered online questionnaires at baseline and a thrice-weekly \'acute phase participant diary\'\n3. Specimen collection for Mpox-related testing Optional components for Part 1 include baseline-only, questionnaire-only, and frequent sampling.\n\nOther optional components for all participants include in the Image Atlas, an online database of clinical images of mpox, designed to provide clinicians and community members of what mpox looks like in real life, and the biobank, which will store research samples for potential future studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Our overarching goal is to characterize key clinical and epidemiologic aspects of Mpox infection in Canada in the context of the rapidly emerging outbreak. As such we will deliberately include people both with (n=250) and without (number to be determined based on accrual of confirmed cases) the condition of interest because it is important to have a comparison group of people who are ultimately confirmed not to have the infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPart 1:\n\n• Being investigated for Mpox infection by a clinician based on clinical (i.e. symptoms) and/or epidemiologic (i.e. exposure to confirmed case) grounds;\n\nPart 2:\n\n* Clinically confirmed to be in the convalescent phase (i.e. confirmed for Mpox infection previously)\n* Within 12 weeks of symptom onset\n\nExclusion Criteria\n\n• None'}, 'identificationModule': {'nctId': 'NCT06291259', 'acronym': 'MPOCS', 'briefTitle': 'Mpox Prospective Observational Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Mpox Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': 'CTO 4081'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Confirmed positive for mpox', 'description': 'Participants with laboratory test results confirming the diagnosis of Mpox. This includes the total number of unique participants who complete the main part 1 study, those who complete the baseline visit only, those who agree to frequent sampling, and those who only participate in part 2.'}, {'label': 'Confirmed negative for mpox', 'description': 'Participants in whom the clinician feels that the diagnosis of Mpox has been clearly ruled out.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Brody Lyon', 'role': 'CONTACT', 'email': 'blyons@bccfe.ca', 'phone': '604-682-2344', 'phoneExt': '66230'}, {'name': 'Mark Hull, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'BC Centre For Excellence', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5B 1T8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Shreya Shah', 'role': 'CONTACT', 'email': 'shreya.khera@unityhealth.to', 'phone': '416-360-4000', 'phoneExt': '77312'}, {'name': 'Darrell HS Tan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Unity Health Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Asmaa Mabrouk', 'role': 'CONTACT', 'email': 'Asmaa.mabrouk@uhn.ca', 'phone': '416-340-4800', 'phoneExt': '2240'}, {'name': 'Sharon Walmsley, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Abby Li', 'role': 'CONTACT', 'email': 'abby.li@unityhealth.to', 'phone': '416-360-4000', 'phoneExt': '77426'}], 'overallOfficials': [{'name': 'Darrell HS Tan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}