Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2026-04-21 @ 1:10 PM
Study NCT ID:
NCT02675166
Status:
COMPLETED
Last Update Posted:
2018-10-22
First Post:
2016-01-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2016-01-22', 'studyFirstSubmitQcDate': '2016-02-04', 'lastUpdatePostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medical complications (post cancer treatment)', 'timeFrame': '15 years after the end of the cancer treatment', 'description': 'The investigators note the medical complications from the end of their cancer treatment to the inclusion visit. Theses complications depend on the type of treatment received.'}], 'secondaryOutcomes': [{'measure': 'MINI questionnaire score', 'timeFrame': '15 years after the end of the cancer treatment', 'description': 'The investigators measured the psychological complications (post cancer treatment) by MINI questionnaire score.'}, {'measure': 'MINI questionnaire score', 'timeFrame': '17 years after the end of the cancer treatment', 'description': 'The investigators measured the psychological complications (post cancer treatment) by MINI questionnaire score.'}, {'measure': 'Quality of life : SF-36 scale', 'timeFrame': '15 years after the end of the cancer treatment', 'description': 'Researchers will focus on the quality of life (measured with the SF-36 scale).'}, {'measure': 'Quality of life : SF-36 scale', 'timeFrame': '17 years after the end of the cancer treatment', 'description': 'Researchers will focus on the quality of life (measured with the SF-36 scale).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Childhood cancer', 'Sequels', 'Complications', 'Surgery', 'Radiotherapy', 'Chemotherapy', 'Cancer'], 'conditions': ['Pediatric Cancer', 'Sequels', 'Complications']}, 'referencesModule': {'references': [{'pmid': '35049375', 'type': 'DERIVED', 'citation': 'Tardy F, Casagranda L, Protiere A, Buisson-Papet G, Garcin A, Trombert-Paviot B, Freycon C, Marec-Berard P, Massoubre C, Berger C. Long-Term Clinical and Psychiatric Complications of Young Adults Cured of a Pediatric Bone Tumor Diagnosed Between 1987 and 1999 in Rhone: Alpes Region (France). J Adolesc Young Adult Oncol. 2022 Dec;11(6):571-579. doi: 10.1089/jayao.2021.0145. Epub 2022 Jan 18.'}]}, 'descriptionModule': {'briefSummary': 'Children cancers are rare and survival rate are around 75%. 1 French adult out of 850 is estimated as a children-cancer-survivor. Chemotherapy, radiotherapy or surgical complications can lead to a late risk of death. A regularly support, a therapeutic education, a support of the psychological difficulties have a positive impact on the quality of life and on long-term health for patients surviving to a cancer.\n\nThe ARCERRA exists, registering around 150 new cases a year. They coordinated, from 2011 to 2014, a multicentric study with a long term follow up in oncology (SALTO). 150 patients diagnosed between 1987 and 1992 were included, and the study demonstrated the feasibility and utility for patients and their physicians of a long-term follow-up coupled with an interview with a psychologist in Rhône-Alpes-Auvergne.\n\nThe primary objective of SALTO-2 project is to know the becoming of young adults that survived to pediatric cancer, diagnosed in Rhône-Alpes between 1993 and 1999. The second objective is in one hand to study the psychological becoming and on another hand, to ameliorate their lifestyle thanks to different documents created specially for them.', 'detailedDescription': "Children cancers are rare and survival rate are around 75%. 1 French adult out of 850 is considered as a children-cancer-survivor. Chemotherapy, radiotherapy or surgical complications can lead to a late risk of death estimated in literature at 14%. A regularly support, a therapeutic education, a support of the psychological difficulties have a positive impact on the quality of life and on long-term health for patients surviving to a cancer. Many countries developed structures able to take care for a long term this kind of patients. In France, such structures are going to be developed.\n\nThe register of cancers concerning children of Rhône-Alpes (ARCERRA) exists since 1987, registering around 150 new cases a year. They coordinated, from 2011 to 2014, a multicentric study with a long term follow up in oncology (SALTO). 150 patients diagnosed between 1987 and 1992 were included, and the study demonstrated the feasibility and utility for patients and their physicians of a long-term follow-up coupled with an interview with a psychologist in Rhône-Alpes-Auvergne.\n\nThe primary objective of SALTO-2 project is to know the becoming of young adults that survived to pediatric cancer, diagnosed in Rhône-Alpes between 1993 and 1999. The second objective is in one hand to study the psychological becoming and on another hand, to ameliorate their lifestyle thanks to different documents created specially for them.\n\nThis is a prospective cohort study of patients surviving cancer (excluding leukemia) diagnosed between 1993 and 1999 in the Rhône- Alpes region before age 15 years. A questionnaire concerning their general situation and their professional life, their shape, and their quality of life will be sent to them. A consultation with an oncologist and an internist if possible will be planned. The two physicians will adapt the consultation according to the SFCE (French society of struggle against cancers and leukemia of children and teenagers) recommendations. They will give the two SFCE's documents.\n\nAfter that, a consultation with a psychologist will be proposed, with a questionnaire MINI evaluating psychological aspect.\n\nTwo years later, a new questionnaire will be delivered to the patients, to check the new events during this period. It will be added to a satisfaction survey, allowing the measure of documents' impact.\n\nThe results will allow the description of the long term impacts for these patients, to answer their eventually questions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is composed of 544 patients registered in the ARCERRA documùent. They survived at a pediatric cancer, diagnosed in Rhône-Alpes between January the 1st 1993 and December the 31st 1999. They were less than 15 years old during this period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had a cancer diagnostic between January the 1st 1993 and December the 31st 1999, before the age of 15 years old, in Rhône-Alpes\n* Being a beneficiary of health insurance\n* Having signed the informed consent form\n\nExclusion Criteria:\n\n* Having been diagnosed with leukemia as a primary cancer'}, 'identificationModule': {'nctId': 'NCT02675166', 'acronym': 'SALTO-2', 'briefTitle': 'Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'SALTO -2 ( Long Term Monitoring In Oncology ) : Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes, Multicentric Study', 'orgStudyIdInfo': {'id': '1508056'}, 'secondaryIdInfos': [{'id': '2015-A00656-43', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric cancer young adult survivors', 'description': '544 patients alive and that are min 18 years old, included in the ARCERRA population register, for a primary cancer (not leukemia), diagnosed between 15 years old, between January the 1st 1993, and December the 31st 1999, in Rhône-Alpes.', 'interventionNames': ['Other: Pediatric cancer young adult survivors']}], 'interventions': [{'name': 'Pediatric cancer young adult survivors', 'type': 'OTHER', 'otherNames': ['Long term follow up'], 'description': 'Patients will receive a questionnaire, a consultation with an oncologist and a psychologist will be planned, and two years later, patients will have to answer again to the questionnaire.', 'armGroupLabels': ['Pediatric cancer young adult survivors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'Chu Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '69000', 'city': 'Lyon', 'country': 'France', 'facility': 'IHOP1 de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'CH Lyon Sud - Pierre Bénite', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '42100', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'BERGER Claire, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}, {'name': 'Léonie CASAGRANDA, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}