Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT02738359
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2016-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-11', 'size': 908610, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-01-08T03:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3250}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2016-04-11', 'studyFirstSubmitQcDate': '2016-04-11', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complication rate', 'timeFrame': '3 years', 'description': 'Percentage of patient having experienced a significant complication from any screening strategy'}, {'measure': 'Comparison of the strategies cost', 'timeFrame': '3 years', 'description': 'Cumulative costs of each strategy compared to the detection of advanced neoplasia/cost per advanced neoplasia detected and cost/life-years gained.'}, {'measure': 'Quality assessment of colonoscopy and capsule endoscopy', 'timeFrame': '3 years', 'description': 'Quality assessment of colonoscopy and capsule endoscopy by analysing the rate of completion of colonoscopy and capsule endoscopy, and the caecal intubation rate.'}], 'primaryOutcomes': [{'measure': 'Prevalence of advanced colorectal neoplasia or cancer identified by each screening strategy (OC, CC and FIT)', 'timeFrame': '3 years', 'description': "The main objective of the study is to compare two alternative methods (CC anf FIT) to OC in term of non-inferiority for the detection of advanced colorectal neoplasia (adenoma \\> 1 cm, adenoma with high grade dysplasia) or cancer. The method of the unilateral confidence interval of the difference will be used to test the non-inferiority. The strategies will be considered to be equivalent if the 95% confidence interval of the difference or the detection of advanced neoplasia won't exceed ±3%."}], 'secondaryOutcomes': [{'measure': 'Rate of colorectal cancer identified by each screening strategy', 'timeFrame': '3 years', 'description': 'The rate of colorectal cancer identified by each strategy (= number of cancer identified by the strategy/number of patients for the strategy) will be calculated at the different steps of the study (t = first exam, t = yearly follow-up and/or interval colonoscopy, t = 3 years upon control colonoscopy) and over the full duration of the study. The rate of initial colorectal cancer, interval colorectal cancer, colorectal cancer at t=3 years and colorectal cancer identified over the duration of the study, respectively, have the same unit, i.e. the number of cancer identified by the strategy/number of patients for the strategy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colon cancer', 'rectum cancer', 'colonoscopy', 'fecal immunological test', 'colon capsule'], 'conditions': ['Colon Cancer', 'Rectum Cancer']}, 'descriptionModule': {'briefSummary': 'Efficacy of colonoscopy, colon capsule and fecal immunological test for colorectal cancer screening, in first degree relatives of patients with colorectal neoplasia: a prospective randomized study.', 'detailedDescription': 'Fecal immunological test (FIT) is the reference screening method in average risk patient. FIT is proposed every 2 years to all asymptomatic subjects with average risk aged from 50 to 74 years in France. Optical colonoscopy (OC) is the gold standard examination for patients at increased risk of colorectal cancer, like those with a first degree relative with colorectal cancer (relative risk between 2 and 4 times that of the general population). Colonoscopy should be performed in this high risk group before 50 years or 5 to 10 years before the earliest case of colorectal cancer. Optical colonoscopy has important limitations: complications (perforation, bleeding), need to use general anesthesia (in France 95% of colonoscopy are performed under general anesthesia), and low acceptability for screening even in high risk persons (40% in the best cases). In this high risk population, there is a potentially important place for alternative methods. FIT could be one of them, with already a significant amount of data suggesting its interest. No data are available in high risk French patients. Colon capsule endoscopy (CC) is a more recent technique with sparse data in this high risk group, and no prospective comparison with optical colonoscopy in this indication. Capsule endoscopy has the advantage of high feasibility, very low risk, probably (but to be demonstrated) increased acceptability, and represents the closest examination as compared to colonoscopy. This justifies a prospective study comparing in a randomized methodology these 3 modalities for the identification of advanced neoplastic lesions of the colon in well characterized group of subjects at high risk of colorectal cancer. The investigators propose a prospective, randomized protocol of non-inferiority in order to compare the two new strategies to the reference strategy for the detection of advanced colorectal neoplasia (colon or rectal cancers, large adenoma \\> 1 cm or high grade dysplasia ; 1st arm: OC first; 2nd arm: CC first, OC at 3 years for those patients with negative initial CC; 3rd arm: annual FIT for 2 years (t0, t = 1 year, t = 2 years), colonoscopy at 3 years for those patients with negative FIT during the study). The new strategies will be considered non-inferior to the reference strategy if the study allows to conclude that the absolute reduction of the proportion of detected patients is not greater than 3% in comparison to the reference strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at high risk of colorectal cancer (first-degree relatives of patient with colorectal cancer) will be included prospectively in one of the 3 comparative arms.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* History of colorectal cancers (any age) in first-degree relatives (parents, children, siblings including half-brothers and sisters)\n* Age \\> or = 45 years\n* No previous colorectal cancer screening\n* Informed patient\n* Patient having signed the consent form\n* Patient affiliated to a social security system or recipient of such system\n\nExclusion criteria:\n\n* Any previous colorectal cancer screening:\n\n * History of blood tests in the stool (hemoccult, fecal immunological test, ...)\n * History of colonic capsule screening\n * History of colonoscopy\n* Any known advanced neoplasia or colorectal cancer\n* Known genetic predisposition to colorectal cancer (very high risk group)\n* Adults protected by law (under guardianship or trusteeship)\n* Other metastatic cancers\n* Life-threatening diseases'}, 'identificationModule': {'nctId': 'NCT02738359', 'acronym': 'FAMCAP', 'briefTitle': 'Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Edouard Herriot'}, 'officialTitle': 'Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening, in First Degree Relatives of Patients With Colorectal Neoplasia: a Prospective Randomized Study.', 'orgStudyIdInfo': {'id': 'FAMCAP'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1rst arm: optical colonoscopy (OC)', 'description': 't0: optical colonoscopy; Follow-up: yearly by phone call for three years', 'interventionNames': ['Procedure: optical colonoscopy']}, {'label': '2nd arm: colon capsule endoscopy (CC)', 'description': 't0: colon capsule endoscopy -\\> if positive: OC; At three years: OC for those patients with negative initial CC; Follow-up: yearly by phone call for 3 years', 'interventionNames': ['Procedure: optical colonoscopy', 'Procedure: colon capsule endoscopy']}, {'label': '3rd arm: fecal immunological test (FIT)', 'description': 'FIT yearly for two years:\n\nt0: FIT -\\> if positive : OC; t = 1 year: FIT -\\> if positive : OC; t = 2 years: FIT -\\> if positive : OC; At three years: OC for those patients with negative FIT during the study Follow-up: yearly by phone call for 3 years', 'interventionNames': ['Procedure: optical colonoscopy', 'Diagnostic Test: fecal immunological test (FIT)']}], 'interventions': [{'name': 'optical colonoscopy', 'type': 'PROCEDURE', 'description': 'optical colonoscopy', 'armGroupLabels': ['1rst arm: optical colonoscopy (OC)', '2nd arm: colon capsule endoscopy (CC)', '3rd arm: fecal immunological test (FIT)']}, {'name': 'colon capsule endoscopy', 'type': 'PROCEDURE', 'description': 'colon capsule endoscopy', 'armGroupLabels': ['2nd arm: colon capsule endoscopy (CC)']}, {'name': 'fecal immunological test (FIT)', 'type': 'DIAGNOSTIC_TEST', 'description': 'fecal immunological test (FIT)', 'armGroupLabels': ['3rd arm: fecal immunological test (FIT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68000', 'city': 'Colmar', 'state': 'Alsace', 'status': 'WITHDRAWN', 'country': 'France', 'facility': 'CH Colmar', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '33604', 'city': 'Pessac', 'state': 'Aquitaine', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'CHU de Bordeaux - Hôpital Haut-Lévêque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '69000', 'city': 'Lyon', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Christophe Saurin, Pr', 'role': 'CONTACT', 'email': 'jean-christophe.saurin@chu-lyon.fr', 'phone': '+33 (0)4 72 11 75 72'}, {'name': 'Olivier Vinet, PhD', 'role': 'CONTACT', 'email': 'olivier.vinet@chu-lyon.fr'}, {'name': 'Jean-Christophe Saurin, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Edouard Herriot - Hospices civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '42270', 'city': 'Saint-Priest-en-Jarez', 'state': 'Auvergne-Rhône-Alpes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie Del Tedesco, MD', 'role': 'CONTACT', 'email': 'emilie.deltedesco@chu-st-etienne.fr', 'phone': '+33 (0)4 77 82 90 78'}, {'name': 'Dupin Mélanie', 'role': 'CONTACT', 'email': 'Melanie.Dupin@chu-st-etienne.fr', 'phone': '+33 (0)4 77 82 88 75'}, {'name': 'Nicolas Williet, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emilie Del Tedesco, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Saint-Etienne - Hôpital nord', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '21000', 'city': 'Dijon', 'state': 'Bourgogne-Franche-Comté', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvain Manfredi, MD', 'role': 'CONTACT', 'email': 'sylvain.manfredi@chu-dijon.fr', 'phone': '+33 (0)3 80 39 34 07'}, {'name': 'Nora Perrot, IRC', 'role': 'CONTACT', 'email': 'nora.perrot@chu-dijon.fr', 'phone': '+33 (0)3 80 28 12 66'}, {'name': 'Sylvain Manfredi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Côme Lepage, Pr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '29200', 'city': 'Brest', 'state': 'Brittany Region', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'CHU de Brest - Hôpital de la Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '35000', 'city': 'Rennes', 'state': 'Brittany Region', 'status': 'WITHDRAWN', 'country': 'France', 'facility': 'CHU de Rennes - Hôpital Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '25030', 'city': 'Besançon', 'state': 'Franche-Comté', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane Koch, MD', 'role': 'CONTACT', 'email': 'skoch@chu-besancon.fr'}, {'name': 'Stéphane Koch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Besançon - Hôpital Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '87000', 'city': 'Limoges', 'state': 'Limousin', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérémie Jacques, MD', 'role': 'CONTACT', 'email': 'jeremiejacques@gmail.com', 'phone': '+33 (0)5 55 05 87 72'}, {'name': 'Jérémie Jacques, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Denis Sauterau, Pr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anne Le Sidaner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Romain Legros, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Limoges - Hôpital Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '31059', 'city': 'Toulouse', 'state': 'Midi-Pyrénées', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karl Barange, MD', 'role': 'CONTACT', 'email': 'barange.k@chu-toulouse.fr', 'phone': '+33 (0)5 61 77 25 27'}, {'name': 'Karl Barange, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '16000', 'city': 'Rouen', 'state': 'Normandy', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane Lecleire, MD', 'role': 'CONTACT', 'email': 'stephane.lecleire@chu-rouen.fr', 'phone': '+33 (0)2 32 88 85 58'}, {'name': 'Stéphane Lecleire, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Rouen - Hôpital Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '44000', 'city': 'Nantes', 'state': 'Pays de la Loire Region', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': "CHU de Nantes - Hôpital de l'Hôtel-Dieu", 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '84000', 'city': 'Avignon', 'state': "Provence-Alpes-Côte d'Azur Region", 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Slim Bramli, MD', 'role': 'CONTACT', 'email': 'sbramli@ch-avignon.fr', 'phone': '+33 (0)4 32 75 33 91'}, {'name': 'Marilyne Grinand', 'role': 'CONTACT', 'email': 'GRINAND.Marilyne@ch-avignon.fr', 'phone': '+33 (0)4 32 75 93 92'}, {'name': 'Jean-Pierre Arpurt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Slim Bramly, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Serge Bellon, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alban Benezech, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "CH d'Avignon", 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '13385', 'city': 'Marseille', 'state': "Provence-Alpes-Côte d'Azur Region", 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe Grandval, MD', 'role': 'CONTACT', 'email': 'philippe.grandval@ap-hm.fr', 'phone': '+33 (0)4 91 38 60 23'}, {'name': 'Philippe Grandval, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital de la Timone - AP-HM', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '06200', 'city': 'Nice', 'state': "Provence-Alpes-Côte d'Azure", 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Geoffroy Vanbiervliet, MD', 'role': 'CONTACT', 'email': 'vanbiervliet.g@chu-nice.fr', 'phone': '+33 (0)4 92 03 60 18'}, {'name': 'Céline Baud', 'role': 'CONTACT', 'email': 'baud.c@chu-nice.fr', 'phone': '+33 (0)4 92 03 59 72'}, {'name': 'Geoffroy Vanbiervliet, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Clément Fortier Beaulieu, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Nice - Hôpital Archet II', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '93000', 'city': 'Bobigny', 'state': 'Île-de-France Region', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Hôpital Avicenne - AP-HP', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '94000', 'city': 'Créteil', 'state': 'Île-de-France Region', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'CHI de Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '75012', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier Dray, Pr', 'role': 'CONTACT', 'email': 'xavier.dray@lrb.aphp.fr', 'phone': '+33 (0)1 49 28 21 60'}, {'name': 'Fouzia Djenadi', 'role': 'CONTACT', 'email': 'endoscopiesat.urcest@aphp.fr', 'phone': '+33 (0)1 49 28 22 02'}, {'name': 'Xavier Dray, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Saint-Antoine - Assistance publique-Hôpitaux de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stanislas Chaussade, Pr', 'role': 'CONTACT'}, {'name': 'Stanislas Chaussade, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Cochin - AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Jean-Christophe Saurin, Pr', 'role': 'CONTACT', 'email': 'jean-christophe.saurin@chu-lyon.fr', 'phone': '+33 (0)4 72 11 75 72'}, {'name': 'olivier vinet, PhD', 'role': 'CONTACT', 'email': 'olivier.vinet@chu-lyon.fr', 'phone': '0472110370'}], 'overallOfficials': [{'name': 'Jean-Christophe Saurin, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Edouard Herriot - Hospices civils de Lyon'}, {'name': 'Robert Benamouzig, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Avicenne - Assistance publique-Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Edouard Herriot', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute, France', 'class': 'OTHER_GOV'}, {'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jean Christophe Saurin', 'investigatorAffiliation': 'Hôpital Edouard Herriot'}}}}