- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04671693
A Post-treatment Program to Identify and Manage Complications Related to Oncology or Hematology Treatments in Cancer Survivors. (PASCA)
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.
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.
METHOD: 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, 22 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.
DISCUSSION: 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Romain BUONO, PharmD, MPH
- Phone Number: +33469856358
- Email: romain.buono@lyon.unicancer.fr
Study Contact Backup
- Name: Meyssane DJEBALI, Msc
- Phone Number: +33469856358
- Email: meyssane.djebali@lyon.unicancer.fr
Study Locations
-
-
-
Lyon, France, 69373
- Recruiting
- Centre Léon Bérard
-
Sub-Investigator:
- Armelle VINCENEUX
-
Sub-Investigator:
- Mehdi BRAHMI
-
Sub-Investigator:
- Amine BELHABRI
-
Sub-Investigator:
- Yann GUILLERMIN
-
Sub-Investigator:
- Laure LEBRAS
-
Sub-Investigator:
- Anne-Sophie MICHALLET
-
Sub-Investigator:
- Franck-Emmanuel NICOLINI
-
Sub-Investigator:
- Philippe REY
-
Sub-Investigator:
- Clemence SANTANA
-
Contact:
- Mauricette MICHALLET, MD
- Phone Number: +33469856358
- Email: mauricette.michallet@lyon.unicancer.fr
-
Sub-Investigator:
- Thomas BACHELOT
-
Sub-Investigator:
- Helen BOYLE
-
Sub-Investigator:
- Aude FLECHON
-
Sub-Investigator:
- Christelle DE LA FOUCHARDIERE
-
Sub-Investigator:
- Pierre-Etienne HEUDEL
-
Sub-Investigator:
- Pierre SAINTIGNY
-
Sub-Investigator:
- Olivier TREDAN
-
Sub-Investigator:
- Philippe TOUSSAINT
-
Sub-Investigator:
- Alice BONNEVILLE-LEVARD
-
Sub-Investigator:
- Béatrice FERVERS
-
Sub-Investigator:
- Marie Adele DAMMACCO
-
Sub-Investigator:
- Christelle FAURE
-
Sub-Investigator:
- Jean-François BRANTUS
-
Sub-Investigator:
- Mellie HEINEMANN
-
Sub-Investigator:
- Léa ROSSI
-
Sub-Investigator:
- Violette MESDAG
-
Sub-Investigator:
- Raphaelle PICARD
-
Sub-Investigator:
- Nicolas CHOPIN
-
Sub-Investigator:
- Mélodie CARBONNAUX
-
Sub-Investigator:
- Emmanuelle NICOLAS-VIRELIZIER
-
Sub-Investigator:
- Souad ASSAAD
-
Sub-Investigator:
- Benoite MERY
-
Sub-Investigator:
- Jessica SERRAND
-
Sub-Investigator:
- Séverine RACADOT
-
Sub-Investigator:
- Waisse WAISSI
-
Sub-Investigator:
- Aude VISY
-
Sub-Investigator:
- Paul POU
-
Sub-Investigator:
- Clémence BONDU
-
Sub-Investigator:
- Ronan TANGUY
-
Sub-Investigator:
- Cécile LAUDE
-
Sub-Investigator:
- Coralie MONCHARMONT
-
Sub-Investigator:
- Christian CARRIE
-
Sub-Investigator:
- Pierre MEEUS
-
Sub-Investigator:
- François GOUIN
-
Sub-Investigator:
- Armelle DUFRESNE
-
Sub-Investigator:
- Jean-Yves BLAY, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years old and ≤ 65 years old.
- Follow-up at the Léon Bérard center
Treated by chemotherapy for one of the following pathologies, and confirmed by the reference diagnostic technique :
- acute myeloid leukemia;
- Hodgkin's lymphoma;
- aggressive non-Hodgkin's lymphoma;
- primary non-metastatic invasive breast carcinoma;
- testicular germ cell tumor treated with at least 3 courses of BEP (bleomycin, etoposide, cisplatin), 4 courses of EP (etoposide, cisplatin) or 4 courses of VIP (etoposide, ifosfamide, cisplatin) received;
- high-grade soft tissue sarcoma, osteosarcoma or Ewing's sarcoma.
- As a complete response at the end of treatment consultation. If end-of-treatment evaluation is not available at the time of inclusion: as an assumed complete response in the opinion of the investigator based on the previous assessment of response.
- Whose capacity to practice an adapted physical activity will have been certified by a medical certificate issued by the investigating physician, the general practitioner or the referring physician.
- Able to understand, read and write French.
- Available and willing to participate in the project throughout the duration of the study.
- Living in the Auvergne-Rhône-Alpes region or in the department of Saône-et-Loire
- Affiliated with a health insurance plan.
- Having declared an attending physician.
- Having signed and dated the informed consent.
Exclusion Criteria:
- With a history of malignancy other than basal cell skin cancer.
- Cannot be followed for medical, social, family, geographical or psychological reasons for the duration of the study.
- Participating in other studies that could impact on the evaluation of the judgement criteria.
- Deprived of liberty by judicial or administrative decision.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PASCA intervention
|
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. Management 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of social precariousness
Time Frame: Month 1
|
Diagnosed by a social worker
|
Month 1
|
Change from Baseline return to work issues incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
Diagnosed by a social worker
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline cognitive problems incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
Diagnosed by a neurologist
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline anxiety crises incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
Diagnosed by a psychologist or psychiatrist
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline depressive events incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
Questionnaire "HADS-D" (Hospital Anxiety and Depression scale)
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline chronic fatigue incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
Questionnaire "MFI-20" (Multidimensional Fatigue Inventory)
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline physical deconditioning incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
A value below the lower limit on at least two of the following physical tests
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline overweight/obesity incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline chronic pain incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline dermatological disorders incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
Common Terminology Criteria for Adverse Events (CTCAE) v5
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline gastrointestinal disorders incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
Common Terminology Criteria for Adverse Events (CTCAE) v5
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline sexual disorders incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
Questionnaire "Sexualité VICAN5"
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline hypogonadism incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
Presence of clinical signs as defined by the International Society for Sexual Medicine A value below the lower limit on at least one of the following blood assay:
|
Month 1, Month 6, Month 24, Month 60
|
Change from 24 months premature ovarian failure incidence at 60 months
Time Frame: Month 24, Month 60
|
|
Month 24, Month 60
|
Change from Baseline osteoporosis incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline chronic kidney failure incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
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.
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline heart failure incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
Diagnosed by a cardiologist with an echocardiography performing the Left Ventricular Ejection Fraction (LVEF) estimate
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline coronary heart disease incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
Diagnosed by a cardiologist conducting at least an interrogation with clinical examination, an estimation of pre-test probability of coronary artery disease
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline respiratory failure incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline hypothyroidism incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline lymphedema incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
Diagnosed by a vascular physician with a perimetric measurement of arms and forearms
|
Month 1, Month 6, Month 24, Month 60
|
Change from Baseline second primary cancers incidence at 60 months
Time Frame: Month 1, Month 6, Month 24, Month 60
|
Pathology report recorded in the patient file.
|
Month 1, Month 6, Month 24, Month 60
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the PASCA program: referrals made through the network
Time Frame: Month 6, Month 24, Month 60
|
Number of referrals made through the network (attending physicians, specialist physicians, supportive care services or other health professionals)
|
Month 6, Month 24, Month 60
|
Evaluate the PASCA program: time between patient referral and completion of the first consultation
Time Frame: Month 6, Month 24, Month 60
|
Average time (days) between patient referral and completion of the first consultation
|
Month 6, Month 24, Month 60
|
Evaluate the PASCA program: patient characteristics
Time Frame: Month 1, Month 6, Month 24, Month 60
|
|
Month 1, Month 6, Month 24, Month 60
|
Evaluation of the impact of program adherence on the evolution of the number of complications detected over time
Time Frame: Month 6, Month 24, Month 60
|
Measurement of the association between program adherence rate and the number of complications detected over time
|
Month 6, Month 24, Month 60
|
Evaluation of the impact of program adherence on quality of life.
Time Frame: Month 6, Month 24, Month 60
|
Measurement of the association between program adherence rate and the overall score on the secondary dimensions of quality of life.
|
Month 6, Month 24, Month 60
|
Description of the PASCA network : characteristics of health professionals sensitive to the post-treatment issues.
Time Frame: Month 6, Month 24, Month 60
|
|
Month 6, Month 24, Month 60
|
Identification of risk factors associated with complications occurring during follow-up.
Time Frame: Month 1, Month 6, Month 24, Month 60
|
Measurement of the association between suspected risk factors and the occurrence of a type of complication, during the duration of follow-up.
|
Month 1, Month 6, Month 24, Month 60
|
Description of the Global Longitudinal Strain
Time Frame: Month 6, Month 24, Month 60
|
Evolution of the Global Longitudinal Strain in absolute value, relative to a later value
|
Month 6, Month 24, Month 60
|
Description of the Left Ventricular Ejection Fraction
Time Frame: Month 6, Month 24, Month 60
|
Evolution of the Left Ventricular Ejection Fraction relative to a later value
|
Month 6, Month 24, Month 60
|
Description of the troponin I level
Time Frame: Month 6, Month 24, Month 60
|
Evolution of the troponin I level relative to a later value
|
Month 6, Month 24, Month 60
|
Description of the Glomerular Filtration Rate
Time Frame: Month 6, Month 24, Month 60
|
Evolution of the Glomerular Filtration Rate estimated by the CKD-EPI equation relative to a later value
|
Month 6, Month 24, Month 60
|
Description of spirometry values
Time Frame: Month 6, Month 24, Month 60
|
Evolution of spirometry values relative to later values :
|
Month 6, Month 24, Month 60
|
Incidence of diabetes mellitus
Time Frame: Month 6, Month 24, Month 60
|
Level of fasting blood glucose
|
Month 6, Month 24, Month 60
|
Incidence of untreated high blood pressure
Time Frame: Month 6, Month 24, Month 60
|
Measure of systolic blood pressure
|
Month 6, Month 24, Month 60
|
Incidence of hypertriglyceridemia
Time Frame: Month 6, Month 24, Month 60
|
Level of triglyceridemia
|
Month 6, Month 24, Month 60
|
Incidence of hyper-LDL-cholesterolemia
Time Frame: Month 6, Month 24, Month 60
|
Level of LDL-cholesterolemia
|
Month 6, Month 24, Month 60
|
Incidence of low level of physical activity
Time Frame: Month 6, Month 24, Month 60
|
Questionnaire "Godin-Shephard Leisure-Time Physical Activity"
|
Month 6, Month 24, Month 60
|
Incidence of insufficiency / deficiency of 25(OH) vitamin D (D2+D3)
Time Frame: Month 6, Month 24, Month 60
|
Level of 25(OH) vitamin D (D2+D3)
|
Month 6, Month 24, Month 60
|
Description of carcinogenic products consumption (tobacco, alcohol, cannabis)
Time Frame: Month 1, Month 6, Month 24, Month 60
|
|
Month 1, Month 6, Month 24, Month 60
|
Evaluation of the Progression-free survival
Time Frame: Month 6, Month 24, Month 60
|
Evaluation of the Progression-free survival
|
Month 6, Month 24, Month 60
|
Evaluation of the Survival without an increase in the number of complications, among those studied
Time Frame: Month 6, Month 24, Month 60
|
Evaluation of the Survival without an increase in the number of complications, among those studied
|
Month 6, Month 24, Month 60
|
Evaluation of the event-free survival
Time Frame: Month 6, Month 24, Month 60
|
Evaluation of the event-free survival
|
Month 6, Month 24, Month 60
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mauricette MICHALLET, PhD, MD, Centre Léon Bérard
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Breast Diseases
- Leukemia
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Lymphoma
- Sarcoma
- Neoplasms, Germ Cell and Embryonal
- Breast Neoplasms
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Hodgkin Disease
- Lymphoma, Non-Hodgkin
- Sarcoma, Ewing
- Osteosarcoma
Other Study ID Numbers
- PASCA
- 2020-A01130-39 (Registry Identifier: IDRCB - French Agency for the Safety of Health Products)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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