Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 3:49 AM
Study NCT ID:
NCT04671693
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2020-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Post-treatment Program to Identify and Manage Complications Related to Oncology or Hematology Treatments in Cancer Survivors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D012516', 'term': 'Osteosarcoma'}, {'id': 'D012512', 'term': 'Sarcoma, Ewing'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients in the study will benefit from the PASCA post-treatment program with 4 visits : at 1 month (T1), 6 month (T2), 24 month (T3) and 60 month (T4) after the end of treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-04-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2020-12-03', 'studyFirstSubmitQcDate': '2020-12-11', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of social precariousness', 'timeFrame': 'Month 1', 'description': 'Diagnosed by a social worker'}, {'measure': 'Change from Baseline return to work issues incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': 'Diagnosed by a social worker'}, {'measure': 'Change from Baseline cognitive problems incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': 'Diagnosed by a neurologist'}, {'measure': 'Change from Baseline anxiety crises incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': 'Diagnosed by a psychologist or psychiatrist'}, {'measure': 'Change from Baseline depressive events incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': 'Questionnaire "HADS-D" (Hospital Anxiety and Depression scale)'}, {'measure': 'Change from Baseline physical deconditioning incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': 'A value below the lower limit on at least two of the following physical tests\n\n* Six-Minute Walk Test (6MWT) (meters)\n* Hand Grip Strength Test (Kg)\n* Five Times Sit to Stand Test (number)\n* Flamingo Test (sec)'}, {'measure': 'Change from Baseline overweight/obesity incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': '* BMI\n* Waist circumference'}, {'measure': 'Change from Baseline chronic pain incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': '* Duration of pain\n* Questionnaire "DN4" (Douleur Neuropathique en 4 questions)'}, {'measure': 'Change from Baseline dermatological disorders incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) v5'}, {'measure': 'Change from Baseline gastrointestinal disorders incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) v5'}, {'measure': 'Change from Baseline sexual disorders incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': 'Questionnaire "Sexualité VICAN5"'}, {'measure': 'Change from Baseline hypogonadism incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': 'Presence of clinical signs as defined by the International Society for Sexual Medicine\n\nA value below the lower limit on at least one of the following blood assay:\n\n* level of total testosterone\n* level of bioavailable testosterone'}, {'measure': 'Change from 24 months premature ovarian failure incidence at 60 months', 'timeFrame': 'Month 24, Month 60', 'description': '* level of Follicle stimulating hormone\n* level of estradiol'}, {'measure': 'Change from Baseline osteoporosis incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': 'T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur'}, {'measure': 'Change from Baseline chronic kidney failure incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': 'Diagnosed on the basis of 2 blood tests within 3 months using the same technique showing a decrease in GFR to \\< 60ml/min/1.73m2, estimated from creatinine levels using the CKD-EPI equation (Chronic Kidney Disease EPIdemiology collaboration, Levey, 2009), albuminuria or proteinuria positive, hematuria, leukocyturia \\> 10/mm3, or morphological abnormality on renal ultrasound.'}, {'measure': 'Change from Baseline heart failure incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': 'Diagnosed by a cardiologist with an echocardiography performing the Left Ventricular Ejection Fraction (LVEF) estimate'}, {'measure': 'Change from Baseline coronary heart disease incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': 'Diagnosed by a cardiologist conducting at least an interrogation with clinical examination, an estimation of pre-test probability of coronary artery disease'}, {'measure': 'Change from Baseline respiratory failure incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': '* Forced Vital Capacity\n* Forced expiratory volume in 1 second\n* Vital capacity\n* Tiffeneau ratio\n* Peak expiratory flow\n* Total lung capacity\n* Diffusing Capacity Of The Lungs For Carbon Monoxide'}, {'measure': 'Change from Baseline hypothyroidism incidence at 60 months', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': '* level of thyroid-stimulating hormone\n* level of total thyroxine'}], 'secondaryOutcomes': [{'measure': 'Evaluate the PASCA program: referrals made through the network', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': 'Number of referrals made through the network (attending physicians, specialist physicians, supportive care services or other health professionals)'}, {'measure': 'Evaluate the PASCA program: time between patient referral and completion of the first consultation', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': 'Average time (days) between patient referral and completion of the first consultation'}, {'measure': 'Evaluate the PASCA program: patients description', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': '* Comorbidities at diagnosis\n* Tumor classification\n* types and doses of each cancer treatments\n* ratio of the number of patients included / number of eligible patients'}, {'measure': 'Evaluation of the patient adherence', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': 'Ratio of the number of prescriptions issued for referral consultations /number of referral consultations actually attended by the patient'}, {'measure': 'Description of the PASCA network : characteristics of health professionals sensitive to the post-treatment issues.', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': '* number of health professionals affiliated with the network\n* type of health professionals affiliated with the network\n* distribution over the Auvergne-Rhône-Alpes region according to medical speciality and department'}, {'measure': 'Identification of risk factors associated with complications occurring during follow-up.', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': 'Measurement of the association between suspected risk factors and the occurrence of a type of complication, during the duration of follow-up.'}, {'measure': 'Description of the Global Longitudinal Strain', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': 'Evolution of the Global Longitudinal Strain in absolute value, relative to a later value'}, {'measure': 'Description of the troponin I level', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': 'Evolution of the troponin I level relative to a later value'}, {'measure': 'Description of the Glomerular Filtration Rate', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': 'Evolution of the Glomerular Filtration Rate estimated by the CKD-EPI equation relative to a later value'}, {'measure': 'Description of spirometry values', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': 'Evolution of spirometry values relative to later values :\n\n* Forced Vital Capacity\n* Forced expiratory volume in 1 second\n* Vital capacity\n* Tiffeneau ratio\n* Peak expiratory flow'}, {'measure': 'Incidence of diabetes mellitus', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': 'Level of fasting blood glucose'}, {'measure': 'Incidence of untreated high blood pressure', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': 'Measure of systolic blood pressure'}, {'measure': 'Incidence of hypertriglyceridemia', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': 'Level of triglyceridemia'}, {'measure': 'Incidence of hyper-LDL-cholesterolemia', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': 'Level of LDL-cholesterolemia'}, {'measure': 'Incidence of low level of physical activity', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': 'Questionnaire "Godin-Shephard Leisure-Time Physical Activity"'}, {'measure': 'Incidence of insufficiency / deficiency of 25(OH) vitamin D (D2+D3)', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': 'Level of 25(OH) vitamin D (D2+D3)'}, {'measure': 'Description of carcinogenic products consumption (tobacco, alcohol, cannabis)', 'timeFrame': 'Month 1, Month 6, Month 24, Month 60', 'description': '* Number of packages years\n* Questionnaire "DETA-Cage"'}, {'measure': 'Evaluation of the Progression-free survival', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': 'Evaluation of the Progression-free survival'}, {'measure': 'Evaluation of the Survival without an increase in the number of complications, among those studied', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': 'Evaluation of the Survival without an increase in the number of complications, among those studied'}, {'measure': 'Evaluation of the event-free survival', 'timeFrame': 'Month 6, Month 24, Month 60', 'description': 'Evaluation of the event-free survival'}, {'measure': 'identification of demographiccs, clinical cancer, treatment-related parameters associated with complications occuring during follow-up', 'timeFrame': 'Month 1, Month 6, Month 24 and Month 60', 'description': 'measurement of the association between demographics, clinical cancer and treatment-related parameters and the occurence of a type of complication during the follow-up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Late Effects', 'Survivors', 'Adults', 'Screening', 'Tertiary prevention', 'Testicular Germ Cell Tumor Mixed', 'Non-Metastatic Breast Carcinoma', 'Soft Tissue Sarcoma', 'Osteosarcoma', "Ewing's Sarcoma", 'Acute Myeloid Leukemia', 'Hodgkin Disease', 'Non Hodgkin Lymphoma'], 'conditions': ['Late Effects', 'Testicular Germ Cell Tumor Mixed', 'Non-Metastatic Breast Carcinoma', 'Soft Tissue Sarcoma, Adult, Stage IIC', 'Osteosarcoma', "Ewing's Sarcoma", 'Acute Myeloid Leukemia', 'Hodgkin Disease', 'Non Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': "INTRODUCTION: Approximately 44% of cancer survivors experience a deteriorated quality of life 5 years after diagnosis due to late onset of complications related to cancer treatments. The objective of the study is to evaluate the incidence rates of treatment-related complications, identify sub-clinical abnormalities and risk factors in patients participating in the PASCA post-treatment program.\n\nMETHOD: PASCA is a single-center, interventional cohort study of adult patients who received at least chemotherapy and with a complete remission to a testicular germ cell tumor, primary non-metastatic invasive breast carcinoma, high-grade soft tissue sarcoma, osteosarcoma, Ewing's sarcoma, acute myeloid leukemia, Hodgkin's or aggressive non-Hodgkin's lymphoma. Four assessment visits will be scheduled at 1 month (T1), 6 months (T2), 24 months (T3) and 60 months (T4) after completion of treatment. During these visits, 19 complications will be screened and follow-up care will be systematically offered to the health professional concerned by the complication in case of a positive result. The screening will contain the following elements: screening self-questionnaires, quality of life questionnaire, 12 biological parameters, a urinalysis evaluating hematuria, proteinuria, and leukocyturia, a spirometry, an electrocardiogram, 5 tests evaluating physical condition, vital signs and the perimetric measurement between both arms.\n\nDISCUSSION: This systematic screening could highlight a number of complications occurring after cancer treatments. Sub-clinical abnormalities and new risk factors could also be identified. This new organization of care could improve the quality of life of adult cancer survivors."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "1. males and females aged 18-65 years;\n2. Diagnosis and management at CLB for one of the following cancers: Hodgkin's lymphoma, aggressive non-Hodgkin's lymphoma, acute myeloid leukemia and primary non metastatic invasive breast cancer (BC), TGCT, or Sarcoma (Soft Tissue Sarcoma, Osteosarcoma, and Ewing's Sarcoma);\n3. receiving first-line intensive chemotherapy;\n4. with a complete response status at the end of the last treatment, which may include chemotherapy (excluding maintenance and hormone therapy), radiotherapy or adjuvant surgery, depending on the last scheduled treatment;\n5. No contraindications to adapted physical activity (APA) at inclusion;\n6. no medical, social, family, or psychological barriers against study participation.\n\nPatients will be excluded if they have a history or coexistence of another primary cancer (except basal cell skin cancer), are participating in another study affecting the primary outcome, are deprived of liberty, or reside outside the Auvergne-Rhône-Alpes region or the Saône-et-Loire department."}, 'identificationModule': {'nctId': 'NCT04671693', 'acronym': 'PASCA', 'briefTitle': 'A Post-treatment Program to Identify and Manage Complications Related to Oncology or Hematology Treatments in Cancer Survivors.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Leon Berard'}, 'officialTitle': 'Study of Complications Related to Treatments in Adults Aged 18 to 65 Years Old Responding to a First Treatment in Oncology or Onco-hematology and Participating in the PASCA (PArcours de Santé au Cours du CAncer) Post-treatment Program.', 'orgStudyIdInfo': {'id': 'PASCA'}, 'secondaryIdInfos': [{'id': '2020-A01130-39', 'type': 'REGISTRY', 'domain': 'IDRCB - French Agency for the Safety of Health Products'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PASCA intervention', 'interventionNames': ['Other: PASCA intervention']}], 'interventions': [{'name': 'PASCA intervention', 'type': 'OTHER', 'description': "At each study visit (T1 = 1 month, T2 = 6 months, T3 = 24 months, T4 = 60 months), an exhaustive screening of complications as well as associated sub-clinical abnormalities and risk factors previously identified as such in the literature, will be conducted.\n\nManagement of complications consists of referring the patient to a healthcare professional belonging to the PASCA network based on the test results. Referral is defined by referring to pre-established decision trees. It is made to a specialist physician, a health professional from the paramedical field or the patient's general practitioner who confirms the diagnosis if necessary and initiates the patient's care and follow-up. These patients also receive their usual follow-up in the context of their tumor pathology in oncology and onco-hematology.", 'armGroupLabels': ['PASCA intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Mauricette MICHALLET, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Leon Berard'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Leon Berard', 'class': 'OTHER'}, 'collaborators': [{'name': 'Malakoff-Humanis', 'class': 'UNKNOWN'}, {'name': 'Fondation Apicil', 'class': 'OTHER'}, {'name': 'Fédération Leucémie Espoir', 'class': 'UNKNOWN'}, {'name': 'Biogaran', 'class': 'UNKNOWN'}, {'name': 'Le défi Anthony', 'class': 'UNKNOWN'}, {'name': 'Novartis', 'class': 'INDUSTRY'}, {'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}