Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT06256068
Eligibility Criteria:
Study group Inclusion criteria
1. age 8-18 years,
2. diagnosis of, and completed treatment for, cancer \>1 year and \<5 years ago,
3. remission of the cancer,
4. treatment involving use of anthracyclines, kinase inhibitors targeting BRC-ABL, hemopoietic stem cell transplantation, and radiotherapy (TBI or mediastinum irradiation),
5. at least 6 weeks since the last signs or symptoms of an infection,
6. written consent signed by the parents/guardians and by patients aged ≥16 years. Control group
a. the same as for the experimental group and, b. cancer treatment without use of anthracyclines, kinase inhibitors targeting BRC-ABL, hemopoietic stem cell transplantation, and radiotherapy (TBI or mediastinum irradiation).
Both groups Exclusion criteria
1. history of another cancer and its treatment with or without the use of anthracyclines, kinase inhibitors targeting BRC-ABL, hemopoietic stem cell transplantation, and radiotherapy (TBI or mediastinum irradiation),
2. significant physical disability or a muscosceletal disorder at the time of the enrollment (congenital or as a consequence of treatment, especially neurological complications and lower extremities conditions and amputation),
3. excessive malaise (at the time of the enrollment),
4. intellectual disability (on the level that disenables the participant from understanding and cooperation during the CPET procedure or ALPHA test),
5. active acute inflammatory disease including the following: autoimmunological, neurological, pulmonological, endocrinological, cardiovascular, and gastrointestinal,
6. platelet count \< 20 G/L,
7. hemoglobin concentration \< 9g /dL,
8. severe residual changes (protein loss syndrome, peritoneal, pericardial or pleural effusion, arrhythmia, metabolic disorders),
9. previously diagnosed congenital heart defects or other heart diseases (including cardiomyopathy, heart failure, arrythmia),
10. relapse of the cancer at the time of enrollment to the study,
11. severe malnutrition \<3 standard deviation (SD) body mass index (BMI) weight for age,
12. chronic concomitant diseases that could affect the CPET outcome, especially endocrinological, neurological, gastrointestinal, and pulmonological\*,
13. lack of patient cooperation.
* endocrinological - decompensated thyroid disease, decompensated diabetes with hypoglycemia; neurological - conditions disabling the CPET performance due to musculoskeletal system alteration, uncontrolled epilepsy, myopathy; gastrointestinal - marasmus, decompensated hepatic insufficiency; pulmonological - asthma, interstitial lung disease, post-infection bronchiolitis obliterans (PIBO) - additionally, pulmonary embolism, lower extremity phlebitis, kidney failure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT06256068
Study Brief:
Protocol Section:
NCT06256068