Late EffectsPASCANCT04671693
A Post-treatment Program to Identify and Manage Complications Related to Oncology or Hematology Treatments in Cancer Survivors.
A study testing PASCA intervention in people with Late Effects and Testicular Germ Cell Tumor Mixed, run by Centre Leon Berard at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Late Effects, Testicular Germ Cell Tumor Mixed, Non-Metastatic Breast Carcinoma
- What is being tested?
- PASCA intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 24 Dec 2020to 24 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- males and females aged 18-65 years;
- 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);
- receiving first-line intensive chemotherapy;
- 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;
- No contraindications to adapted physical activity (APA) at inclusion;
- no medical, social, family, or psychological barriers against study participation.
Patients 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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, 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.
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.
- Conditions
- Late Effects, Testicular Germ Cell Tumor Mixed, Non-Metastatic Breast Carcinoma, Soft Tissue Sarcoma, Adult, Stage IIC, Osteosarcoma, Ewing's Sarcoma
- Being tested
- PASCA intervention
- 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
- Medical subject headings
- Sarcoma, Osteosarcoma, Sarcoma, Ewing, Leukemia, Myeloid, Acute, Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASCA interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PASCA intervention | Experimental | Not described Receives: Other: PASCA intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of social precariousness
Diagnosed by a social worker
Measured: Month 1
Change from Baseline return to work issues incidence at 60 months
Diagnosed by a social worker
Measured: Month 1, Month 6, Month 24, Month 60
Change from Baseline cognitive problems incidence at 60 months
Diagnosed by a neurologist
Measured: Month 1, Month 6, Month 24, Month 60
Change from Baseline anxiety crises incidence at 60 months
Diagnosed by a psychologist or psychiatrist
Measured: Month 1, Month 6, Month 24, Month 60
Change from Baseline depressive events incidence at 60 months
Questionnaire "HADS-D" (Hospital Anxiety and Depression scale)
Measured: Month 1, Month 6, Month 24, Month 60
Change from Baseline physical deconditioning incidence at 60 months
A value below the lower limit on at least two of the following physical tests
- Six-Minute Walk Test (6MWT) (meters)
- Hand Grip Strength Test (Kg)
- Five Times Sit to Stand Test (number)
- Flamingo Test (sec)
Measured: Month 1, Month 6, Month 24, Month 60
Change from Baseline overweight/obesity incidence at 60 months
- BMI
- Waist circumference
Measured: Month 1, Month 6, Month 24, Month 60
Change from Baseline chronic pain incidence at 60 months
- Duration of pain
- Questionnaire "DN4" (Douleur Neuropathique en 4 questions)
Measured: Month 1, Month 6, Month 24, Month 60
Change from Baseline dermatological disorders incidence at 60 months
Common Terminology Criteria for Adverse Events (CTCAE) v5
Measured: Month 1, Month 6, Month 24, Month 60
Change from Baseline gastrointestinal disorders incidence at 60 months
Common Terminology Criteria for Adverse Events (CTCAE) v5
Measured: Month 1, Month 6, Month 24, Month 60
Change from Baseline sexual disorders incidence at 60 months
Questionnaire "Sexualité VICAN5"
Measured: Month 1, Month 6, Month 24, Month 60
Change from Baseline hypogonadism incidence at 60 months
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:
- level of total testosterone
- level of bioavailable testosterone
Measured: Month 1, Month 6, Month 24, Month 60
Change from 24 months premature ovarian failure incidence at 60 months
- level of Follicle stimulating hormone
- level of estradiol
Measured: Month 24, Month 60
Change from Baseline osteoporosis incidence at 60 months
T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur
Measured: Month 1, Month 6, Month 24, Month 60
Change from Baseline chronic kidney failure incidence at 60 months
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.
Measured: Month 1, Month 6, Month 24, Month 60
Change from Baseline heart failure incidence at 60 months
Diagnosed by a cardiologist with an echocardiography performing the Left Ventricular Ejection Fraction (LVEF) estimate
Measured: Month 1, Month 6, Month 24, Month 60
Change from Baseline coronary heart disease incidence at 60 months
Diagnosed by a cardiologist conducting at least an interrogation with clinical examination, an estimation of pre-test probability of coronary artery disease
Measured: Month 1, Month 6, Month 24, Month 60
Change from Baseline respiratory failure incidence at 60 months
- Forced Vital Capacity
- Forced expiratory volume in 1 second
- Vital capacity
- Tiffeneau ratio
- Peak expiratory flow
- Total lung capacity
- Diffusing Capacity Of The Lungs For Carbon Monoxide
Measured: Month 1, Month 6, Month 24, Month 60
Change from Baseline hypothyroidism incidence at 60 months
- level of thyroid-stimulating hormone
- level of total thyroxine
Measured: Month 1, Month 6, Month 24, Month 60
Secondary outcomes (21)
Evaluate the PASCA program: referrals made through the network
Number of referrals made through the network (attending physicians, specialist physicians, supportive care services or other health professionals)
Measured: Month 6, Month 24, Month 60
Evaluate the PASCA program: time between patient referral and completion of the first consultation
Average time (days) between patient referral and completion of the first consultation
Measured: Month 6, Month 24, Month 60
Evaluate the PASCA program: patients description
- Comorbidities at diagnosis
- Tumor classification
- types and doses of each cancer treatments
- ratio of the number of patients included / number of eligible patients
Measured: Month 1, Month 6, Month 24, Month 60
Evaluation of the patient adherence
Ratio of the number of prescriptions issued for referral consultations /number of referral consultations actually attended by the patient
Measured: Month 1, Month 6, Month 24, Month 60
Description of the PASCA network : characteristics of health professionals sensitive to the post-treatment issues.
- number of health professionals affiliated with the network
- type of health professionals affiliated with the network
- distribution over the Auvergne-Rhône-Alpes region according to medical speciality and department
Measured: Month 6, Month 24, Month 60
Identification of risk factors associated with complications occurring during follow-up.
Measurement of the association between suspected risk factors and the occurrence of a type of complication, during the duration of follow-up.
Measured: Month 1, Month 6, Month 24, Month 60
Description of the Global Longitudinal Strain
Evolution of the Global Longitudinal Strain in absolute value, relative to a later value
Measured: Month 6, Month 24, Month 60
Description of the troponin I level
Evolution of the troponin I level relative to a later value
Measured: Month 6, Month 24, Month 60
Description of the Glomerular Filtration Rate
Evolution of the Glomerular Filtration Rate estimated by the CKD-EPI equation relative to a later value
Measured: Month 6, Month 24, Month 60
Description of spirometry values
Evolution of spirometry values relative to later values :
- Forced Vital Capacity
- Forced expiratory volume in 1 second
- Vital capacity
- Tiffeneau ratio
- Peak expiratory flow
Measured: Month 6, Month 24, Month 60
Incidence of diabetes mellitus
Level of fasting blood glucose
Measured: Month 6, Month 24, Month 60
Incidence of untreated high blood pressure
Measure of systolic blood pressure
Measured: Month 6, Month 24, Month 60
Incidence of hypertriglyceridemia
Level of triglyceridemia
Measured: Month 6, Month 24, Month 60
Incidence of hyper-LDL-cholesterolemia
Level of LDL-cholesterolemia
Measured: Month 6, Month 24, Month 60
Incidence of low level of physical activity
Questionnaire "Godin-Shephard Leisure-Time Physical Activity"
Measured: Month 6, Month 24, Month 60
Incidence of insufficiency / deficiency of 25(OH) vitamin D (D2+D3)
Level of 25(OH) vitamin D (D2+D3)
Measured: Month 6, Month 24, Month 60
Description of carcinogenic products consumption (tobacco, alcohol, cannabis)
- Number of packages years
- Questionnaire "DETA-Cage"
Measured: Month 1, Month 6, Month 24, Month 60
Evaluation of the Progression-free survival
Evaluation of the Progression-free survival
Measured: Month 6, Month 24, Month 60
Evaluation of the Survival without an increase in the number of complications, among those studied
Evaluation of the Survival without an increase in the number of complications, among those studied
Measured: Month 6, Month 24, Month 60
Evaluation of the event-free survival
Evaluation of the event-free survival
Measured: Month 6, Month 24, Month 60
identification of demographiccs, clinical cancer, treatment-related parameters associated with complications occuring during follow-up
measurement of the association between demographics, clinical cancer and treatment-related parameters and the occurence of a type of complication during the follow-up
Measured: Month 1, Month 6, Month 24 and Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start24 Dec 2020
- Primary completion24 Jan 2029 (estimated)
- Study completion24 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Malakoff-Humanis, Fondation Apicil, Fédération Leucémie Espoir, Biogaran, Le défi Anthony, Novartis, Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Mauricette MICHALLET, PhD, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671693
- Sponsor's protocol ID
- PASCA
- Other IDs
- 2020-A01130-39
- Acronym
- PASCA
- Status last verified
- Aug 2025
- First submitted
- 3 Dec 2020
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04671693
- Acronym / sponsor ID
- PASCA / PASCA
- Conditions
- Late Effects, Testicular Germ Cell Tumor Mixed, Non-Metastatic Breast Carcinoma, Soft Tissue Sarcoma, Adult, Stage IIC, Osteosarcoma, Ewing's Sarcoma
- Keywords
- Late Effects, Survivors, Adults, Screening, Tertiary prevention, Testicular Germ Cell Tumor Mixed, Non-Metastatic Breast Carcinoma, Soft Tissue Sarcoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Malakoff-Humanis, Fondation Apicil, Fédération Leucémie Espoir, Biogaran, Le défi Anthony, Novartis, Roche Pharma AG
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 24 Jan 2029 (estimated)
- Study completion
- 24 Apr 2029 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PASCA intervention | Experimental | Other: PASCA intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PASCA interventionAt 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. | Other | PASCA intervention |
Primary outcome
Incidence of social precariousness
Time frame: Month 1
Diagnosed by a social worker
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
Change from Baseline cognitive problems incidence at 60 months
Time frame: Month 1, Month 6, Month 24, Month 60
Diagnosed by a neurologist
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
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)
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 * Six-Minute Walk Test (6MWT) (meters) * Hand Grip Strength Test (Kg) * Five Times Sit to Stand Test (number) * Flamingo Test (sec)
Change from Baseline overweight/obesity incidence at 60 months
Time frame: Month 1, Month 6, Month 24, Month 60
* BMI * Waist circumference
Change from Baseline chronic pain incidence at 60 months
Time frame: Month 1, Month 6, Month 24, Month 60
* Duration of pain * Questionnaire "DN4" (Douleur Neuropathique en 4 questions)
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
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
Change from Baseline sexual disorders incidence at 60 months
Time frame: Month 1, Month 6, Month 24, Month 60
Questionnaire "Sexualité VICAN5"
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: * level of total testosterone * level of bioavailable testosterone
Change from 24 months premature ovarian failure incidence at 60 months
Time frame: Month 24, Month 60
* level of Follicle stimulating hormone * level of estradiol
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
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.
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
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
Change from Baseline respiratory failure incidence at 60 months
Time frame: Month 1, Month 6, Month 24, Month 60
* Forced Vital Capacity * Forced expiratory volume in 1 second * Vital capacity * Tiffeneau ratio * Peak expiratory flow * Total lung capacity * Diffusing Capacity Of The Lungs For Carbon Monoxide
Change from Baseline hypothyroidism incidence at 60 months
Time frame: Month 1, Month 6, Month 24, Month 60
* level of thyroid-stimulating hormone * level of total thyroxine
21 secondary outcomes
Evaluate the PASCA program: referrals made through the network
Time frame: 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
Evaluate the PASCA program: patients description
Time frame: Month 1, Month 6, Month 24, Month 60
Evaluation of the patient adherence
Time frame: Month 1, 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
Identification of risk factors associated with complications occurring during follow-up.
Time frame: Month 1, Month 6, Month 24, Month 60
Description of the Global Longitudinal Strain
Time frame: Month 6, Month 24, Month 60
Description of the troponin I level
Time frame: Month 6, Month 24, Month 60
Description of the Glomerular Filtration Rate
Time frame: Month 6, Month 24, Month 60
Description of spirometry values
Time frame: Month 6, Month 24, Month 60
Incidence of diabetes mellitus
Time frame: Month 6, Month 24, Month 60
Incidence of untreated high blood pressure
Time frame: Month 6, Month 24, Month 60
Incidence of hypertriglyceridemia
Time frame: Month 6, Month 24, Month 60
Incidence of hyper-LDL-cholesterolemia
Time frame: Month 6, Month 24, Month 60
Incidence of low level of physical activity
Time frame: 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
Description of carcinogenic products consumption (tobacco, alcohol, cannabis)
Time frame: 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 Survival without an increase in the number of complications, among those studied
Time frame: Month 6, Month 24, Month 60
Evaluation of the event-free survival
Time frame: Month 6, Month 24, Month 60
identification of demographiccs, clinical cancer, treatment-related parameters associated with complications occuring during follow-up
Time frame: Month 1, Month 6, Month 24 and Month 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauricette MICHALLET, PhD, MD principal investigator
Centre Leon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PASCA intervention in people with Late Effects and Testicular Germ Cell Tumor Mixed, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of social precariousness (time frame: Month 1). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.