Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
Study NCT ID:
NCT03625661
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
2018-07-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522335', 'term': 'ferric carboxymaltose'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'cohort study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2018-07-04', 'studyFirstSubmitQcDate': '2018-08-09', 'lastUpdatePostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the quality of life of patients with iron deficiency with or without anemia during treatment for their cancer', 'timeFrame': '42 months', 'description': 'Obtained with the quality of life with the FACT-An questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Estimation of the proportion of absolute iron deficiency', 'timeFrame': '42 months', 'description': 'Absolute iron deficiency is defined by a ferritin level \\<300 μg / L and a transferrin saturation coefficient \\<20%.'}, {'measure': 'Estimation of the proportion of functional iron deficiency', 'timeFrame': '42 months', 'description': 'Functional iron deficiency is defined by a ferritin level \\<800 μg / L and a Transferrin Saturation Coefficient \\<20%.'}, {'measure': 'Estimation of the proportion of iron deficiency as a whole', 'timeFrame': '42 months', 'description': 'Addition of proportion of iron deficiency'}, {'measure': 'Estimation proportion of symptomatic anemia', 'timeFrame': '42 months', 'description': 'Symptomatic anemia is defined as hemoglobin \\<12 g / dL associated with pallor and anoxic functional symptoms'}, {'measure': 'Estimation of the proportion of asymptomatic anemia', 'timeFrame': '42 months', 'description': 'Asymptomatic anemia is defined as hemoglobin \\<12 g / dL without clinical signs.'}, {'measure': 'Estimation of the proportion of anemia as a whole', 'timeFrame': '42 months', 'description': 'Addition of proportion of asymptomatic anemia and symptomatic anemia'}, {'measure': 'Estimation of the proportion of undernourished patients', 'timeFrame': '42 months', 'description': 'The diagnosis of malnutrition will be done by calculating BMI (\\<18.5 si - 70 years old and \\<21 from 70 years old)'}, {'measure': 'Estimation of the evolution of the functional capacities of the patient', 'timeFrame': '42 months', 'description': 'Estimated by functional questionnaire (Berg Balanced Scale test)'}, {'measure': 'Estimation of the evolution of the functional capacities of the patient', 'timeFrame': '42 months', 'description': 'Estimated by functional questionnaire (the Tinetti test)'}, {'measure': 'Estimation of the evolution of the functional capacities of the patient', 'timeFrame': '42 months', 'description': 'Estimated by functional questionnaire (the Timed Up and Go test)'}, {'measure': 'Estimation of the evolution of the functional capacities of the patient', 'timeFrame': '42 months', 'description': 'Estimated by functional questionnaire (the 6-minute walk test)'}, {'measure': 'Estimation of the evolution of the functional capacities of the patient', 'timeFrame': '42 months', 'description': 'Estimated by functional questionnaire (the 1-minute sit-stand test)'}, {'measure': 'Estimation of the evolution of the functional capacities of the patient', 'timeFrame': '42 months', 'description': 'Estimated by functional questionnaire (the climb and descent test of a staircase for 1 minute)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Treatment Related Cancer,iron deficiency'], 'conditions': ['Iron Deficiency Anemia']}, 'referencesModule': {'references': [{'pmid': '35380718', 'type': 'DERIVED', 'citation': 'Gluszak C, de Vries-Brilland M, Seegers V, Baroin C, Kieffer H, Delva R, Cornuault-Foubert D. Impact of Iron-Deficiency Management on Quality of Life in Patients with Cancer: A Prospective Cohort Study (CAMARA Study). Oncologist. 2022 Apr 5;27(4):328-333. doi: 10.1093/oncolo/oyac005.'}]}, 'descriptionModule': {'briefSummary': 'In oncology, anemia is a frequent symptom, leading to complication of patient management for, more or less, a long term but often poorly evaluated by medical teams.\n\nIn oncology, anemia is induced by multiple causes. Iron deficiency appears to be a leading cause of anemia, especially in people with solid cancer. Iron deficiency is characterized by a low level of iron . Iron is a trace element required for life. It is a major component of hemoglobin allowing the transport of oxygen in red blood cells. There are in fact 2 types of iron deficiency: an absolute iron deficiency with a deficiency of true iron and a functional iron deficiency. Since end of January 2014, intravenous iron-based injections have been reclassified for cancer patients at ICO Paul Papin. The monitoring of iron deficiency with or without anemia is currently done in our institute, the ICO-Paul Papin. There is a procedure for the management of anemia with or without iron deficiency but there is still no traceability of treatments performed, their compliance or even their impact on the rate hemoglobin and the quality of life of patients during their treatment. This observatory also makes it possible to evaluate the impact of this treatment on the quality of life of the patients and thus allows them a personalized care of the tiredness during their treatment', 'detailedDescription': 'The study is for patients with iron deficiency and / or anemia during treatment for cancer These patients will receive ferinject. Patients will perform functional assessments and complete quality of life questionnaires, when the ferinject will be injected, then at 1 month and 6 months.\n\nPatients will be followed for 6 months in the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient with cancer regardless of the location\n* Patient with specific treatment (chemotherapy +/- targeted therapy and / or radiotherapy, hormone therapy or surgery)\n* Patient with Functional Iron Deficiency or absolute with or without anemia\n* Having given written informed consent prior to any procedure related to the study.\n\nExclusion Criteria:\n\n* Patient in a palliative situation not receiving specific treatment for their cancer\n* Patient is willing and able to comply with the protocol for the duration of the study including all scheduled treatment, visits and examinations\n* Patient with myeloproliferative disease\n* Contraindication to treatments for iron deficiency and / or anemia\n* Pregnant woman, parturient or nursing mothers\n* Patient has no valid health insurance\n* Disorder precluding understanding of trial information or informed consent'}, 'identificationModule': {'nctId': 'NCT03625661', 'acronym': 'CAMARA', 'briefTitle': 'Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'Impact and Evaluation of the Management of Iron Deficiency With or Without Anemia in Patients With Cancer', 'orgStudyIdInfo': {'id': 'ICO-A-2013-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm with Ferinject', 'description': 'Ferinject will be administered once at inclusion', 'interventionNames': ['Drug: Ferinject']}], 'interventions': [{'name': 'Ferinject', 'type': 'DRUG', 'otherNames': ['carboxymaltose ferrique'], 'description': 'Ferinject 50mg/ml, one injection', 'armGroupLabels': ['Arm with Ferinject']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': "Institut de Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'DELPHINE CORNUAULT-FOUBERT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut de Cancérologie de l'Ouest"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}