Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-26 @ 9:41 AM
Study NCT ID:
NCT04792892
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2021-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ANCA II - Quality of Life and Functional Outcome in Patients With Anal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001005', 'term': 'Anus Neoplasms'}], 'ancestors': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2035-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2021-03-10', 'studyFirstSubmitQcDate': '2021-03-10', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QoL', 'timeFrame': '3 months after diagnosis', 'description': 'Health related QoL at'}, {'measure': 'Urinary function', 'timeFrame': '3 months after diagnosis', 'description': 'Evaluate urinary dysfunction'}, {'measure': 'Bowel function', 'timeFrame': '3 months after diagnosis', 'description': 'Evaluate bowelfunction'}, {'measure': 'Sexual function', 'timeFrame': '3 months after diagnosis', 'description': 'Evaluate sexual function'}, {'measure': 'Toxicity related to treatment', 'timeFrame': '3 months after diagnosis', 'description': 'Number of patients with severe toxicity from the chemoradiotherapy'}], 'secondaryOutcomes': [{'measure': 'QoL', 'timeFrame': '12 months after diagnosis', 'description': 'QoL measured on a 7 point likert scale at 12 months'}, {'measure': 'Urinary function', 'timeFrame': '12 months after diagnosis', 'description': 'Urinary dysfuntion measured as incontinence at 12 months'}, {'measure': 'Bowel function', 'timeFrame': '12 months after diagnosis', 'description': 'Bowel dysfunction measured at 12 months'}, {'measure': 'Sexual function', 'timeFrame': '12 months after diagnosis', 'description': 'Sexual dysfunction measured at 12 months'}, {'measure': 'QoL', 'timeFrame': '3 years after diagnosis', 'description': 'QoL measured on a 7 point likert scale at 3 years'}, {'measure': 'Urinary function', 'timeFrame': '3 years after diagnosis', 'description': 'Urinary function at 3 years'}, {'measure': 'Bowel funcction', 'timeFrame': '3 years after diagnosis', 'description': 'Bowel dysfunction at 3 years'}, {'measure': 'Sexual function', 'timeFrame': '3 years after diagnosis', 'description': 'Sexual dysfunction at 3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anal Cancer']}, 'descriptionModule': {'briefSummary': 'Anal cancer is a rare disease, but the incidence is rising. About 200 patients will get this type of cancer yearly in Sweden. Curative treatment includes chemotherapy and radiotherapy. The prognosis is good, but some patients will have recurrent or persistent disease after concluded chemo-radiotherapy and will then be offered salvage surgery. Some patients develop distant metastases that can be treated with good results.\n\nThe aim of this study is to identify and describe functional outcome in patients diagnosed with anal cancer. We will study patients from diagnosis, try to identify early toxicity to treatment and then identify long-term morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with newly diagnosed anal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Anal squamous carcinoma diagnosed within the last 2 months\n\nExclusion Criteria:\n\n-No informed consent'}, 'identificationModule': {'nctId': 'NCT04792892', 'acronym': 'ANCAII', 'briefTitle': 'ANCA II - Quality of Life and Functional Outcome in Patients With Anal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'ANCA II - Quality of Life and Functional Outcome in Patients With Anal Cancer', 'orgStudyIdInfo': {'id': 'ANCA II'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with a new diagnosis of anal cancer', 'description': 'All patients identified at our national tumour board will be offered to participate', 'interventionNames': ['Other: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Patients will be answering questionnaires at 0, 3, 12, 36, 60 and 120 months', 'armGroupLabels': ['Patients with a new diagnosis of anal cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE 416 85', 'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Eva Angenete, MD,PhD', 'role': 'CONTACT', 'email': 'eva.angenete@vgregion.se', 'phone': '+46313438410'}], 'facility': 'Dept. of Surgery, Sahlgrenska University Hospital/Ostra', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Eva Angenete', 'role': 'CONTACT', 'email': 'eva.angenete@vgregion.se', 'phone': '0760514441'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eva Angenete', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}