Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-28 @ 9:00 PM
Study NCT ID:
NCT04049357
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2019-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Care for Colon 2015
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D000236', 'term': 'Adenoma'}], '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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The investigators will include 124.214 consecutive citizens from the Region of Southern Denmark when they are invited for screening. The participants will be randomized into two groups using an automated randomization tool provided by Odense Patient data Explorative Network (OPEN). The randomization will be based on Zelen's pre-randomization principle and will take place prior to citizens receiving the invitation. The individuals are randomized into 62.107 people allocated in the intervention group and 62.107 allocated in the control group."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2031}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2019-08-05', 'studyFirstSubmitQcDate': '2019-08-07', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CCE detection rate of polyps compared to OC', 'timeFrame': 'Within 30 days', 'description': 'The investigators aim to conduct a large scale randomized trial to investigate the implementation of CCE as part of the Danish screening protocol.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Camera Capsule Endoscopy', 'Colorectal cancer screening', 'Optical colonoscopy', 'Colorectal cancer'], 'conditions': ['Colorectal Cancer', 'Adenoma']}, 'referencesModule': {'references': [{'pmid': '37364794', 'type': 'BACKGROUND', 'citation': 'Deding U, Boggild H, Baatrup G, Kaalby L, Hjelmborg J, Thygesen MK, Schelde-Olesen B, Kobaek-Larsen M; CareForColon2015 study group. Socioeconomic differences in expected discomfort from colonoscopy and colon capsule endoscopy. Prev Med. 2023 Aug;173:107593. doi: 10.1016/j.ypmed.2023.107593. Epub 2023 Jun 24.'}, {'pmid': '39100485', 'type': 'BACKGROUND', 'citation': 'Deding U, Boggild H, Kaalby L, Hjelmborg J, Kobaek-Larsen M, Thygesen MK, Schelde-Olesen B, Bjorsum-Meyer T, Baatrup G; CareForColon2015 study group. Socioeconomic differences in discrepancies between expected and experienced discomfort from colonoscopy and colon capsule endoscopy. Heliyon. 2024 Jul 8;10(14):e34274. doi: 10.1016/j.heliyon.2024.e34274. eCollection 2024 Jul 30.'}, {'pmid': '40210462', 'type': 'BACKGROUND', 'citation': 'Baatrup G, Bjorsum-Meyer T, Kaalby L, Schelde-Olesen B, Kobaek-Larsen M, Koulaouzidis A, Kroijer R, Al-Najami I, Buch N, Hogh A, Qvist N, Thygesen MK, Deding U; CareForColon2015 study group. Choice of colon capsule or colonoscopy versus default colonoscopy in FIT positive patients in the Danish screening programme: a parallel group randomised controlled trial. Gut. 2025 Sep 8;74(10):1616-1623. doi: 10.1136/gutjnl-2024-333687.'}, {'pmid': '34790535', 'type': 'BACKGROUND', 'citation': 'Deding U, Bjorsum-Meyer T, Kaalby L, Kobaek-Larsen M, Thygesen MK, Madsen JB, Kroijer R, Baatrup G. Colon capsule endoscopy in colorectal cancer screening: Interim analyses of randomized controlled trial CareForColon2015. Endosc Int Open. 2021 Nov 12;9(11):E1712-E1719. doi: 10.1055/a-1546-8727. eCollection 2021 Nov.'}, {'pmid': '32601101', 'type': 'BACKGROUND', 'citation': 'Kaalby L, Deding U, Kobaek-Larsen M, Havshoi AV, Zimmermann-Nielsen E, Thygesen MK, Kroeijer R, Bjorsum-Meyer T, Baatrup G. Colon capsule endoscopy in colorectal cancer screening: a randomised controlled trial. BMJ Open Gastroenterol. 2020 Jun;7(1):e000411. doi: 10.1136/bmjgast-2020-000411.'}, {'pmid': '39449979', 'type': 'DERIVED', 'citation': 'Schelde-Olesen B, Koulaouzidis A, Deding U, Toth E, Dabos KJ, Eliakim A, Carretero C, Gonzalez-Suarez B, Dray X, de Lange T, Beaumont H, Rondonotti E, Kopylov U, Ellul P, Perez-Cuadrado-Robles E, Robertson A, Stenfors I, Bojorquez A, Piccirelli S, Raabe GG, Margalit-Yehuda R, Barba I, Scardino G, Ouazana S, Bjorsum-Meyer T. Bowel cleansing quality evaluation in colon capsule endoscopy: what is the reference standard? Therap Adv Gastroenterol. 2024 Oct 23;17:17562848241290256. doi: 10.1177/17562848241290256. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The investigatior believe that implementing camera capsule endoscopy as a filter test to colonoscopy will increase screening participation, increase the number of individuals with detected intermediate- high risk adenomas or cancer, reduce the colonoscopy demand and reduce the number of complications.', 'detailedDescription': 'The Danish national colorectal cancer screening program includes all citizens aged 50-74 years, who are invited biennially to a fecal test for invisible blood in the stool. If the test is positive the citizen is invited for a colonoscopy. 90% of the test-positive undergo colonoscopy. The detected cancers are at a significant earlier stage and survival from screening detected cancer is higher. It is also expected that cancer incidence will drop due to removal of the advanced adenomas before they develop into cancer. Although initial results are positive, there is room for improvement. Additionally there are rare but serious complications to colonoscopy in the form of bleeding or bowel perforation.\n\nThrough four years the investigators have tested the colon capsule endoscopy method, and find that the investigation is associated with significantly less discomfort and that the diagnostic ability to find polyps \\> 1 cm is better than colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in the Danish colorectal screening program\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04049357', 'acronym': 'CFC2015', 'briefTitle': 'Care for Colon 2015', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Colon Capsule Endoscopy in Bowel Cancer Screening. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The intervention group', 'description': 'If the FIT test is returned and positive the individual can choose either Camera Capsule Endoscopy (CCE) or Optical colonoscopy (OC) as the primary bowel investigation. If OC is chosen, it is performed as standard and the participant outcomes remains analyzed in the intervention group as intention to treat.\n\nIf CCE is chosen an out-clinic CCE will be done at one of four regional sites. Overall and segmental bowel preparation grade (Leighton-Rex 1-4) and all pathological findings are reported. If the anal verge is identified without video blackout in the colon the transit is considered complete. Any incomplete CCE investigation will be followed by standard optical endoscopy to the extent needed to investigate the proportion of the colon not visualized by the capsule and remove any detected polyps. If the CCE is complete with complete transit and adequate preparation, individuals with more than two polyps or one polyp over 9 mm will be referred for colonoscopy.', 'interventionNames': ['Device: Camera Capsule Endoscopy/ PillCam']}, {'type': 'NO_INTERVENTION', 'label': 'The control group', 'description': 'The control group will be invited to screening as usual. The intervention group will be informed that if the fecal test is returned and positive they can either choose to have an initial colon capsule endoscopy, and only colonoscopy if significant findings are made or an initial colonoscopy as usual.'}], 'interventions': [{'name': 'Camera Capsule Endoscopy/ PillCam', 'type': 'DEVICE', 'description': 'Camera Capsule Endoscopy in screening', 'armGroupLabels': ['The intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5700', 'city': 'Svendborg', 'country': 'Denmark', 'facility': 'Odense University Hospital, Svendborg Sygehus', 'geoPoint': {'lat': 55.05982, 'lon': 10.60677}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}