Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT05328960
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2022-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Pandemic's Effect on Diagnosis and Treatment of Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'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': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2022-04-13', 'studyFirstSubmitQcDate': '2022-04-13', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Yearly incidence of rectal cancer', 'timeFrame': '2019-2022', 'description': 'The number of patients diagnosed yearly 2019, 2020, 2021 and 2022'}], 'secondaryOutcomes': [{'measure': 'Symptoms at diagnosis', 'timeFrame': '6 months prior diagnosis', 'description': 'Symptoms at diagnosis as reported by patients'}, {'measure': "Patient's delay", 'timeFrame': '12 months prior diagnosis', 'description': 'Delay from symptoms until doctors appointment'}, {'measure': "Doctor's delay", 'timeFrame': '12 months prior diagnosis', 'description': "Delay from doctor's appointment until diagnosis"}, {'measure': 'Treatment changes', 'timeFrame': 'Diagnosis and 12 months following', 'description': 'Any changes from the treatment plan due to covid-19'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer']}, 'descriptionModule': {'briefSummary': 'Colorectal cancer is common with an annual prevalence of 6000. The majority can be cured and the five year survival rate is over 60%. In december 2019 reports came in about SARS-Cov-2, which later was named Covid-19. The World Health Organization classified it as a pandemic in March 2020. In Sweden the number of patients with Covid-19 increased mainly in the urban areas in March 2020. Care for patients with other diseases were affected and local changes from guidelines were adopted. In some regions and countries the indications for adjuvant and neoadjuvant treatment for colorectal cancer were somewhat changed. The number of patients diagnosed with colorectal cancer also decreased, as well as other types of cancer. The true effect on outcome with a delayed diagnosis remains unknown.\n\nThe aim of this study is to evaluate the effects of the Covid-19 pandemic on the diagnosis, treatment and survival of patients with colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients that are diagnosed with rectal cancer and identified in the Swedish ColoRectal Cancer Registry will be included. They will be contacted by phone and mail regarding a questionnaire.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rectal cancer diagnosis 2019-2022\n\nExclusion Criteria:\n\n* No rectal cancer diagnosis 2019-2022'}, 'identificationModule': {'nctId': 'NCT05328960', 'acronym': 'CovidRC', 'briefTitle': "The Pandemic's Effect on Diagnosis and Treatment of Rectal Cancer", 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'An Analysis of Covid-19 Effect on Patients With Colorectal Cancer - Follow-up Regarding Tumour Stage, Neoadjuvant Treatment, Delay and Long-term Survival', 'orgStudyIdInfo': {'id': 'CovidRC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients diagnosed before, during or after the pandemic', 'description': 'Patients with rectal cancer', 'interventionNames': ['Other: Diagnosed during or not during the pandemic']}], 'interventions': [{'name': 'Diagnosed during or not during the pandemic', 'type': 'OTHER', 'description': 'We will create a group of patients that are diagnosed before and after the pandemic and one group diagnosed during the pandemic', 'armGroupLabels': ['Patients diagnosed before, during or after the pandemic']}]}, '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'}, {'name': 'Anette Wedin, RN', 'role': 'CONTACT'}], 'facility': 'Dept. of Surgery, Sahlgrenska University Hospital/Ostra', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Eva Angenete, MD. PhD', 'role': 'CONTACT', 'email': 'eva.angenete@vgregion.se', 'phone': '0760514441'}, {'name': 'Anette Wedin, RN', 'role': 'CONTACT', 'email': 'anette.wedin@vgregion.se'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eva Angenete', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}