Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT04714203
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2021-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of the Prevalence of Sarcopenia in Early Palliative Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2021-01-15', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of sarcopenia', 'timeFrame': '1 month', 'description': 'Number of patients with sarcopenia in the numerator out of the total number of patients included in the study in the denominator'}], 'secondaryOutcomes': [{'measure': 'Prevalence of undernutrition', 'timeFrame': '1 month', 'description': 'Number of patients with nutritional disorders at inclusion in numerator out of the number of patients followed in denominator'}, {'measure': 'Overall survival', 'timeFrame': '6 months', 'description': 'Time between the inclusion date and the date of death regardless of the cause or the date of the latest news if the patient is censored'}, {'measure': 'Progression free survival', 'timeFrame': '6 months', 'description': 'Time between the inclusion date and the date of the first examination showing Time disease progression or the date of death if the patient is deceased or the date of the latest news if the patient is censored'}, {'measure': 'Event free survival', 'timeFrame': '6 months', 'description': 'Time between the date of inclusion and the date of the first event identified or the date of death if the patient is deceased or the date of the latest news if the patient is censored'}, {'measure': 'Correlation between PRONOPALL score and sarcopenia', 'timeFrame': '1 months', 'description': 'Calculation of PRONOPALL score (high score corresponds to a worse situation)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Cancer']}, 'descriptionModule': {'briefSummary': "Cancer is one of the leading causes of death in the world after cardiovascular disease (8.7 million deaths in 2015 for 17.5 million cases) 1. Despite a great deal of progress in disease detection and treatment, the incidence of cancer is steadily increasing (+ 33% in 2015) and particularly in certain locations (pancreas, lungs, brain and stomach), including risk factors are not always identified.\n\nAdvanced stage cancer (= metastatic) is most often incurable with the exception of germ cell tumors. Palliative care is then most often offered. Palliative care favors the patient's quality of life as a whole (medical, physical, psychological and social).\n\nThe symptoms most often reported by patients are: pain, fatigue, decreased appetite, nausea, and are directly related to phenomena such as cachexia, loss of autonomy and deterioration of psychological state, resulting in decreased overall survival. Chemotherapies and targeted therapies (immunotherapy, hormonal therapy, participation in a clinical trial) can provide a benefit in quality of life and survival only in the early phase (little benefit in the terminal phase).\n\nOther prognostic factors can impact the quality of life and overall survival in these situations: sarcopenia and disorders of nutritional status (obesity, undernutrition).\n\nThe study of sarcopenia by CT scan of patients in a palliative situation is still too scarce. Sarcopenia is an often underestimated event and is associated with older age, co-morbidities, increased infectious complications, and early mortality.\n\nThe study of the prevalence of sarcopenia by CT scan would confirm its prognostic impact in a palliative situation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population will include all patients diagnosed with metastatic disease (either present at diagnosis or occurring after an initially localized cancer).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\> 18 years old,\n* patient with solid cancer diagnosed with metastatic disease,\n* having had a biological assessment and a CT scan in the month preceding the medical consultation,\n* and whose prognosis is considered palliative\n\nExclusion Criteria:\n\n* age \\<18 years old,\n* adults under guardianship measure,\n* pregnancy or breastfeeding in progress,\n* malignant hemopathies,\n* metastatic germ cell tumors,\n* non-metastatic disease'}, 'identificationModule': {'nctId': 'NCT04714203', 'acronym': 'SPACE', 'briefTitle': 'Assessment of the Prevalence of Sarcopenia in Early Palliative Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Weprom'}, 'officialTitle': 'Assessment of the Prevalence of Sarcopenia in Early Palliative Cancer Patients', 'orgStudyIdInfo': {'id': 'WP-2019-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cohort', 'description': 'Sarcopenia assessment', 'interventionNames': ['Other: sarcopenia assessment']}], 'interventions': [{'name': 'sarcopenia assessment', 'type': 'OTHER', 'description': 'evaluation of sarcopenia status', 'armGroupLabels': ['cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72000', 'city': 'Le Mans', 'country': 'France', 'facility': 'Clinique Victor Hugo / Centre Jean Bernard', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}], 'overallOfficials': [{'name': 'Katell LE DU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Victor Hugo/Centre Jean Bernard'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weprom', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}