Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-06 @ 6:05 PM
Study NCT ID:
NCT02727894
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2016-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Colorectal Cancer: Screening vs. Non-Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D000072662', 'term': 'Margins of Excision'}], 'ancestors': [{'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jan.kral@centrum.cz', 'phone': '+420605273008', 'title': 'Jan Král', 'organization': 'Institution for Clinical and Experimental Medicine'}, 'certainAgreement': {'otherDetails': 'Results can be published exclusively by the main investigator or after main investigator approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Adverse event data were not collected because data were mainly obtained at the time of diagnosis or at the time of treatment plan setting.\n\nStudy was focused on comparing screening group and non-screening group at the time of diagnosis and confirm the efficiency of the screening programme.', 'eventGroups': [{'id': 'EG000', 'title': 'Screening Group', 'description': 'Patients with colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after FOBT).', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-screening Group', 'description': 'Symptomatic CRC was defined as carcinoma detected by CT, MR or sonography and then verified by colonoscopy.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Colorectal Cancer Stage (pTNM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening Group', 'description': 'Patients with colorectal cancer diagnosed by screening procedures (primary screening colonoscopy, colonoscopy after iFOBT).'}, {'id': 'OG001', 'title': 'Non-Screening Group', 'description': 'Symptomatic CRC was defined as cancer diagnosed in symptomatic patients by colonoscopy, or by CT, MRI or ultrasonography before verification by colonoscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at time of diagnosis', 'description': 'Differences between colorectal cancer stage (0,I,II) in screening vs. non-screening group.\n\n* 0\\. stage (Tis N0 M0)\n* I. stage (T1-2 N0 M0)\n* II. stage (T3-4 N0 M0)\n* III. stage (T1-4 N1-2 M0)\n* IV. stage (T1-4 N1-2 M1)\n\nStages 0,I II were considered to have better outcome', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Colorectal Cancer Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening Group', 'description': 'Patients with colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after iFOBT).'}, {'id': 'OG001', 'title': 'Non-screening Group', 'description': 'Symptomatic CRC (non-screening group) was defined as cancer diagnosed in symptomatic patients by colonoscopy, or by CT, MRI or ultrasonography before verification by colonoscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'after surgery was performed', 'description': 'Differences between colorectal cancer grade in screening vs. non-screening group.\n\n* GX (cannot be identified)\n* G1 (well diff.)\n* G2 (moderately diff.)\n* G3 (poorly diff.)\n* G4 (undifferentiated)\n\nGrades 1,2 were considered to have connection with lower stage', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Colorectal Cancer Resection Margins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening Group', 'description': 'Patients with colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after iFOBT).'}, {'id': 'OG001', 'title': 'Non-screening Group', 'description': 'Symptomatic CRC was defined as cancer diagnosed in symptomatic patients by colonoscopy, or by CT, MRI or ultrasonography before verification by colonoscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'after surgery was performed', 'description': 'Difference between colorectal cancer resection margins (RX, R0, R1, R2) in screening vs. non-screening group.\n\n* RX: cannot be identified\n* R0: no cancer cells seen microscopically at the resection margin\n* R1: cancer cells present microscopically at the resection margin (microscopic positive margin)\n* R2: gross examination by the naked eye shows tumor tissue present at the resection margin (macroscopic positive margin)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Colorectal Cancer Metastasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening Group', 'description': 'Patients with colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after iFOBT).'}, {'id': 'OG001', 'title': 'Non-Screening Group', 'description': 'Symptomatic CRC was defined as cancer diagnosed in symptomatic patients by colonoscopy, or by CT, MRI or ultrasonography before verification by colonoscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at time of diagnosis', 'description': 'Differences between occurrence of colorectal cancer metastasis (MX, M0, M1) between screening vs. non-screening group.\n\n* MX: cannot be measured\n* M0: cancer has not spread to other parts of the body\n* M1: cancer has spread to other parts of the body', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Colorectal Cancer Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening Group', 'description': 'Patients with colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after iFOBT).'}, {'id': 'OG001', 'title': 'Non-Screening Group', 'description': 'Symptomatic CRC was defined as cancer diagnosed in symptomatic patients by colonoscopy, or by CT, MRI or ultrasonography before verification by colonoscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '35'}, {'value': '21.5', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'time between diagnosis and surgery, measured after surgery was performed', 'description': 'Median time between diagnosis and surgery.', 'unitOfMeasure': 'Number of day betw. diagnosis and surg.', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Colorectal Cancer and Palliative Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Screening Group', 'description': 'Patients with colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after iFOBT).'}, {'id': 'OG001', 'title': 'Non-Screening Group', 'description': 'Symptomatic CRC was defined as cancer diagnosed in symptomatic patients by colonoscopy, or by CT, MRI or ultrasonography before verification by colonoscopy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during treatment plan setting', 'description': 'Differences between neoadjuvant, adjuvant and systemic palliative therapy in screening vs. non-screening group.\n\nNumber of patients treated with palliative therapy in both groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Screening Group', 'description': 'CRC diagnosed by screening was defined as cancer diagnosed by primary screening colonoscopy, or colonoscopy after a positive immunochemical based faecal occult blood test (iFOBT) in patients without symptoms invited to examination according to the national screening programme policy'}, {'id': 'FG001', 'title': 'Non-screening Group', 'description': 'Symptomatic CRC was defined as cancer diagnosed in symptomatic patients.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'March 2013', 'groupId': 'FG000', 'numSubjects': '73'}, {'comment': 'March 2013', 'groupId': 'FG001', 'numSubjects': '192'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'September 2015', 'groupId': 'FG000', 'numSubjects': '73'}, {'comment': 'September 2015', 'groupId': 'FG001', 'numSubjects': '192'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'From March 2013 till September 2015 in 12 centres across the Czech Republic 276 patients were enrolled.', 'preAssignmentDetails': 'Patients with diagnosed colorectal carcinoma were enrolled (276). 11 patients were excluded because of the inability to categorise those patients into the screening or non-screening group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Screening', 'description': 'Patients with colorectal cancer diagnosed by screening procedures (primary screening colonoscopy, colonoscopy after FOBT).'}, {'id': 'BG001', 'title': 'Others', 'description': 'Patients with colorectal cancer diagnosed by other diagnostic procedures (diagnostic colonoscopy, CT, magnetic resonance, ultrasonography, urgent surgery, etc.)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age (years, median)', 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '91'}, {'value': '70', 'groupId': 'BG001', 'lowerLimit': '33', 'upperLimit': '91'}, {'value': '68', 'groupId': 'BG002', 'lowerLimit': '33', 'upperLimit': '91'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 276}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-03', 'studyFirstSubmitDate': '2016-03-30', 'resultsFirstSubmitDate': '2017-08-19', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-03', 'studyFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colorectal Cancer Stage (pTNM)', 'timeFrame': 'at time of diagnosis', 'description': 'Differences between colorectal cancer stage (0,I,II) in screening vs. non-screening group.\n\n* 0\\. stage (Tis N0 M0)\n* I. stage (T1-2 N0 M0)\n* II. stage (T3-4 N0 M0)\n* III. stage (T1-4 N1-2 M0)\n* IV. stage (T1-4 N1-2 M1)\n\nStages 0,I II were considered to have better outcome'}], 'secondaryOutcomes': [{'measure': 'Colorectal Cancer Grade', 'timeFrame': 'after surgery was performed', 'description': 'Differences between colorectal cancer grade in screening vs. non-screening group.\n\n* GX (cannot be identified)\n* G1 (well diff.)\n* G2 (moderately diff.)\n* G3 (poorly diff.)\n* G4 (undifferentiated)\n\nGrades 1,2 were considered to have connection with lower stage'}, {'measure': 'Colorectal Cancer Resection Margins', 'timeFrame': 'after surgery was performed', 'description': 'Difference between colorectal cancer resection margins (RX, R0, R1, R2) in screening vs. non-screening group.\n\n* RX: cannot be identified\n* R0: no cancer cells seen microscopically at the resection margin\n* R1: cancer cells present microscopically at the resection margin (microscopic positive margin)\n* R2: gross examination by the naked eye shows tumor tissue present at the resection margin (macroscopic positive margin)'}, {'measure': 'Colorectal Cancer Metastasis', 'timeFrame': 'at time of diagnosis', 'description': 'Differences between occurrence of colorectal cancer metastasis (MX, M0, M1) between screening vs. non-screening group.\n\n* MX: cannot be measured\n* M0: cancer has not spread to other parts of the body\n* M1: cancer has spread to other parts of the body'}, {'measure': 'Colorectal Cancer Surgery', 'timeFrame': 'time between diagnosis and surgery, measured after surgery was performed', 'description': 'Median time between diagnosis and surgery.'}, {'measure': 'Colorectal Cancer and Palliative Therapy', 'timeFrame': 'during treatment plan setting', 'description': 'Differences between neoadjuvant, adjuvant and systemic palliative therapy in screening vs. non-screening group.\n\nNumber of patients treated with palliative therapy in both groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Screening', 'pTNM', 'Metastasis', 'Chemotherapy', 'Resection Margins', 'Colorectal Cancer'], 'conditions': ['Colorectal Cancer', 'Screening']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after immunochemical based faecal occult blood test) has more favourable clinical-pathological characteristics than colorectal cancer diagnosed for symptoms. We aimed to compare these two groups of patients at the time of diagnosis and confirm the efficiency of the screening programme.', 'detailedDescription': "Multicentre prospective observational study. 12 centres across the Czech rep. included. Study approved by Ethical Committee.\n\nAll participants gave their informed signed consent. Each centre was assigned a unique ID number to distinguish between the locations in which patients were enrolled.\n\nPatients informations were stored under identification number in secure internet database (RedCap) run by The International Clinical Research Center of St. Anne's University Hospital Brno.REDCap is a secure, web-based application designed to support data capture for research studies.\n\nStatistical analysis was done with SAS, ver. 9.3. Descriptive statistics such as absolute and relative frequencies and median with 95 % confidence intervals were used. Differences between the screening and non-screening groups were compared using the Chi-square test or Fisher's exact test (categorical parameters) and Mann-Whitney test (continuous parameters). Results with a p-value \\< 0.05 were considered statistically significant"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinics, university hospitals, private practices', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newly diagnosed colorectal cancer\n\nExclusion Criteria:\n\n* unsigned informed consent\n* mental disorder'}, 'identificationModule': {'nctId': 'NCT02727894', 'acronym': 'CRC', 'briefTitle': 'Colorectal Cancer: Screening vs. Non-Screening', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute for Clinical and Experimental Medicine'}, 'officialTitle': 'Colorectal Cancer Screening Detects Tumors at Earlier Stages Improving Clinical Outcomes', 'orgStudyIdInfo': {'id': '00023001-2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Screening Group', 'description': 'CRC diagnosed by screening was defined as cancer diagnosed by primary screening colonoscopy, or colonoscopy after a positive immunochemical based faecal occult blood test i(FOBT) in patients without symptoms invited to examination according to the national screening programme policy'}, {'label': 'Non-screening Group', 'description': 'Symptomatic CRC was defined as cancer diagnosed in symptomatic patients.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14021', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Institute for Clinical and Experimental Medicine', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Jan Král, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Clinical and Experimental Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Clinical and Experimental Medicine', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Private practice at Hluboká nad Vltavou', 'class': 'UNKNOWN'}, {'name': 'Klaudian Hospital Mladá Boleslav', 'class': 'UNKNOWN'}, {'name': 'Masaryk Hospital Usti nad Labem', 'class': 'OTHER'}, {'name': 'Brno University Hospital', 'class': 'OTHER'}, {'name': 'Medic Kral Ltd.', 'class': 'UNKNOWN'}, {'name': 'Chomutov Hospital', 'class': 'UNKNOWN'}, {'name': 'Tomas Bata Hospital, Czech Republic', 'class': 'OTHER'}, {'name': 'Military University Hospital, Prague', 'class': 'OTHER'}, {'name': 'Frýdek-Místek Hospital', 'class': 'UNKNOWN'}, {'name': 'The University Hospital Plzeň', 'class': 'UNKNOWN'}, {'name': 'Vitkovice Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Jan Král, MD', 'investigatorAffiliation': 'Institute for Clinical and Experimental Medicine'}}}}