Tumors of the Central Nervous SystemNCT05641636
Cardiovascular Disorders and Risk Factors in Childhood Cranial and Craniospinal Tumors Survivors
An observational study of Tumors of the Central Nervous System and Childhood Cancer Survivors, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
The purpose of research is to study to adverse cardiovascular disorder and risks factors in childhood cranial and craniospinal tumors survivors. In this research the investigators investigate cardiological instrumental diagnostic, such as electrocardiography, echocardiography with the determination of global… Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumors of the Central Nervous System, Childhood Cancer Survivors
- What is being tested?
- 12-lead ECG, hormone and lipid blood tests, echocardiography (Echo-CG), cardiopulmonary exercise testing (CPET) and pulse wave analysis
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 11 Nov 2019to 28 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: childhood cancer survivals after complex management of cranial and craniospinal tumors formed the main group
Who may be able to join
- radiation and chemotherapy for cranial and craniospinal tumors in childhood or adolescence
- completion of the therapy at least one year before enrollment
- signed informed consent
- there were three separate types of informed consent - for adults, for minors and for their parents
- minors were signing informed consent in the presence of their parents.
Who cannot join
- standard contraindications to exercise testing
- anemia, pregnancy
- psychiatric disease
- alcohol or drug abuse
- active malignancy
- acute infection
Trial locations and contacts
1 site in 1 country.
Russia1 site
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow
About this study
The purpose of research is to study to adverse cardiovascular disorder and risks factors in childhood cranial and craniospinal tumors survivors. In this research the investigators investigate cardiological instrumental diagnostic, such as electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan for the prediction of cardiovascular complications after cranial and craniospinal radiotherapy and chemotherapy.
Read the detailed description
Cardiovascular disease, after recurrence of the original cancer and development of second primary cancers, has been reported to be the leading cause of premature mortality among long-term childhood cancer survivors. Childhood cancer survivors after chemotherapy and radiotherapy for cranial and craniospinal tumors are at increased risk of transient ischemic attack, ischemic stroke. The mechanisms of vascular damage are not well understood. Preventive measures are not developed.
The purpose of my research is to study to adverse cardiovascular disorder and risks factors in childhood cranial and craniospinal tumors survivors.
Cardiovascular risk factors monitoring and modification, development of nursing and follow-up guides of adult patients may improve outcomes in these patients after treatment for cranial and craniospinal tumors in childhood. Attempts to develop more individualized risk prediction for cardiovascular disease may help refine surveillance and counseling in the future.
This was an open prospective observational study. 68 people were enrolled in the study: 48 childhood cancer survivals after complex management of cranial and craniospinal tumors formed the main group, and 20 healthy people formed the control group.
Criteria of inclusion to the main group were: age 16-40 years, radiation and chemotherapy for cranial and craniospinal tumors in childhood or adolescence, completion of the therapy at least one year before enrollment, signed informed consent. There were three separate types of informed consent - for adults, for minors and for their parents. Minors were signing informed consent in the presence of their parents.
Criteria of inclusion to the control group for healthy volunteers were demographics comparable to the main group.
Criteria of exclusion were: standard contraindications to exercise testing, anemia, pregnancy, psychiatric disease, alcohol or drug abuse, active malignancy, acute infection.
The study has been approved by the local ethics committee. At baseline, all patients underwent comprehensive evaluation including collection of medical history, complete physical exam, 12-lead ECG, hormone and lipid blood tests, echocardiography (Echo-CG), cardiopulmonary exercise testing (CPET) and pulse wave analysis. Additional carotid duplex scanning was performed in patients after craniospinal radiation therapy.
Echocardiography Left ventricular (LV) systolic and diastolic function, cardiac chamber volumes, valve function and systolic pulmonary artery pressure were evaluated using conventional transthoracic 2D-echocardiography (Dimension/Vivid 7 PRO, General Electric Medical System, Norway) according to current guidelines. Left ventricle (LV) end diastolic volume (LVEDV), end systolic volume (LVESV) and ejection fraction (LVEF) were measured with the modified Simpson method.
Cardiopulmonary exercise testing CPET was conducted on a treadmill (Intertrack 8100, Schiller, Switzerland) with a breath-by-breath algorithm of gas exchange analysis (Cardiovit CS-200 Ergo-Spiro, Schiller, Switzerland), using Bruce, modified Bruce or Naughton protocols depending on the level of physical tolerance. The researchers evaluated VO2 peak (highest oxygen uptake attained during exercise) and METs as its derivative, percentage from predicted VO2 peak (based on age, sex, height, and weight), anaerobic threshold (AT, defined by the V-slope method as the level of oxygen uptake at the moment of dislinear rise in minute ventilation and CO2 output relative to VO2, reflecting the shift to anaerobic metabolism and bicarbonate buffering of increased lactic acid), O2 pulse (VO2 peak/peak heart rate), ventilatory equivalent for carbon dioxide (VE/VCO2 slope), end-tidal CO2 pressure at rest and at peak exercise (PetCO2 rest and PetCO2 peak). Patient's effort was considered substantial if the self-reported number using a 1-10 modified Borg scale was ≥ 7 points and respiratory exchange ratio (RER, defined as VCO2/VO2 ratio) was ≥1.0.
Endothelial function assessment Pulse wave characteristics were obtained using finger photopletysmography (PPG) (Angioscan-01, AngioScan-Electronics) from an infrared light sensor. The amount of light transmitted to the finger directly depends on the alterations in its blood flow. The signal obtained during PPG is displayed as a digital volume pulse (DVP) waveform. This wave usually demonstrates two deflections: an early systolic peak (a), reflecting a direct pressure wave propagation from the left ventricle to the finger, and the diastolic peak (b), that reflects backward pressure wave propagation to the aorta. The time between these two peaks (peak-to-peak time, PPT) is proportional to the subject's height. We measured large artery stiffness index (SI, a ratio between the length of aorta calculated automatically based on height to PPT), reflection index of small resistive arteries (RI, calculated as b/a x 100%), augmentation index (AI, defined as the ratio between late and early systolic pulse wave peaks, expressed as percent from the pulse pressure) and augmentation index normalized for pulse rate of 75 beats per minute (AIp75%) with regard to the fact that the heart rate has a major impact on the augmentation of pulse pressure. Endothelial function was also evaluated using occlusion index and shear rate during post-occlusive reactive hyperemia (PORH) representing the magnitude of limb reperfusion after a brief period of brachial artery occlusion. The probe was performed in the morning hours in supine position after 15 minutes of rest in a comfortable quiet warm environment according to a standardized protocol on subject preparation (fasting state, restriction of moderate-to-high physical activity, nicotine, alcohol, caffeine or other vasoactive drugs 24 hours before the probe).
Statistical analysis Microsoft Excel spreadsheet application was used for data storage and preparation for future analysis. Statistical analysis was performed using Prism 9.2.0 software. Python software was applied for multiple logistic regression models. The continuous data were expressed as a mean value (M) ± standard deviation (SD) with a 95% confidence interval (CI). Categorical variables were presented in absolute numbers and percentage and computed by using two-tailed Fischer's exact test. Normality of distribution for quantitative variables was tested using Anderson-Darling test as the first step and using Student t-test or Mann-Whitney U-test as the second step. Normality of distribution was initially evaluated as well before correlation analysis with a Pearson coefficient for normal data and with a Spearmen coefficient for non-normal data. Multiple regression models were performed considering multiple testing of hypotheses. The results of the study were presented as histograms with pairwise comparison of correlation matrices. P-value <0.05 was considered significant.
- Being tested
- 12-lead ECG, hormone and lipid blood tests, echocardiography (Echo-CG), cardiopulmonary exercise testing (CPET) and pulse wave analysis
- Keywords
- brain tumors in children, risk of cardiovascular disease, radiation therapy, dyslipidemia, endothelial dysfunction, cardiopulmonary testing
- Medical subject headings
- Central Nervous System Neoplasms, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-lead ECG, hormone and lipid blood tests, echocardiography (Echo-CG), cardiopulmonary exercise testing (CPET) and pulse wave analysisDiagnostic test
Echocardiography - standart protocol. Pulse wave characteristics were obtained using finger photopletysmography (PPG) (Angioscan-01, AngioScan-Electronics) from an infrared light sensor. Endothelial function was also evaluated using occlusion index and shear rate during post-occlusive reactive hyperemia (PORH). CPET was conducted on a treadmill (Intertrack 8100, Schiller, Switzerland) with a breath-by-breath algorithm of gas exchange analysis (Cardiovit CS-200 Ergo-Spiro, Schiller, Switzerland), using Bruce, modified Bruce or Naughton protocols depending on the level of physical tolerance.
| Study group | Role | What they receive |
|---|---|---|
| childhood cancer survivors - the main group | childhood cancer survivals after complex management of cranial and craniospinal tumors formed the main group Receives: Diagnostic Test: 12-lead ECG, hormone and lipid blood tests, echocardiography (Echo-CG), cardiopulmonary exercise testing (CPET) and pulse wave analysis | |
| the control group | healthy people formed the control group Receives: Diagnostic Test: 12-lead ECG, hormone and lipid blood tests, echocardiography (Echo-CG), cardiopulmonary exercise testing (CPET) and pulse wave analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyslipidemia
change сoncentration of total cholesterol >5 mmol/l, change сoncentration of LDL > 3 mmol/l, сoncentration of HDL <1,2 mmol/l, change сoncentration of TG >1,7 mmol/
Measured: At baseline and through study completion of 1 year
endotelian dysfunction
change in endothelial function by Angioscan
Measured: At baseline and through study completion of 1 year
change in exercise tolerance
change anaerobic threshold<14,0 ml/kg/min
Measured: At baseline and through study completion of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start11 Nov 2019
- Primary completion30 Dec 2021
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumors of the Central Nervous SystemStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641636
- Sponsor's protocol ID
- A-3011
- Status last verified
- Nov 2022
- First submitted
- 27 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Disorders and Risk Factors in Childhood Cranial and Craniospinal Tumors Survivors
- ClinicalTrials.gov ID
- NCT05641636
- Acronym / sponsor ID
- A-3011
- Keywords
- brain tumors in children, risk of cardiovascular disease, radiation therapy, dyslipidemia, endothelial dysfunction, cardiopulmonary testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 7 Dec 2022 (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.
The purpose of research is to study to adverse cardiovascular disorder and risks factors in childhood cranial and craniospinal tumors survivors. In this research the investigators investigate cardiological instrumental diagnostic, such as electrocardiography, echocardiography with the determination of global longitudinal strain, cardiopulmonary exercise test, and diagnostic of endothelial function by Angioscan for the prediction of cardiovascular complications after cranial and craniospinal radiotherapy and chemotherapy.
Detailed description
Cardiovascular disease, after recurrence of the original cancer and development of second primary cancers, has been reported to be the leading cause of premature mortality among long-term childhood cancer survivors. Childhood cancer survivors after chemotherapy and radiotherapy for cranial and craniospinal tumors are at increased risk of transient ischemic attack, ischemic stroke. The mechanisms of vascular damage are not well understood. Preventive measures are not developed.
The purpose of my research is to study to adverse cardiovascular disorder and risks factors in childhood cranial and craniospinal tumors survivors.
Cardiovascular risk factors monitoring and modification, development of nursing and follow-up guides of adult patients may improve outcomes in these patients after treatment for cranial and craniospinal tumors in childhood. Attempts to develop more individualized risk prediction for cardiovascular disease may help refine surveillance and counseling in the future.
This was an open prospective observational study. 68 people were enrolled in the study: 48 childhood cancer survivals after complex management of cranial and craniospinal tumors formed the main group, and 20 healthy people formed the control group.
Criteria of inclusion to the main group were: age 16-40 years, radiation and chemotherapy for cranial and craniospinal tumors in childhood or adolescence, completion of the therapy at least one year before enrollment, signed informed consent. There were three separate types of informed consent - for adults, for minors and for their parents. Minors were signing informed consent in the presence of their parents.
Criteria of inclusion to the control group for healthy volunteers were demographics comparable to the main group.
Criteria of exclusion were: standard contraindications to exercise testing, anemia, pregnancy, psychiatric disease, alcohol or drug abuse, active malignancy, acute infection.
The study has been approved by the local ethics committee. At baseline, all patients underwent comprehensive evaluation including collection of medical history, complete physical exam, 12-lead ECG, hormone and lipid blood tests, echocardiography (Echo-CG), cardiopulmonary exercise testing (CPET) and pulse wave analysis. Additional carotid duplex scanning was performed in patients after craniospinal radiation therapy.
Echocardiography Left ventricular (LV) systolic and diastolic function, cardiac chamber volumes, valve function and systolic pulmonary artery pressure were evaluated using conventional transthoracic 2D-echocardiography (Dimension/Vivid 7 PRO, General Electric Medical System, Norway) according to current guidelines. Left ventricle (LV) end diastolic volume (LVEDV), end systolic volume (LVESV) and ejection fraction (LVEF) were measured with the modified Simpson method.
Cardiopulmonary exercise testing CPET was conducted on a treadmill (Intertrack 8100, Schiller, Switzerland) with a breath-by-breath algorithm of gas exchange analysis (Cardiovit CS-200 Ergo-Spiro, Schiller, Switzerland), using Bruce, modified Bruce or Naughton protocols depending on the level of physical tolerance. The researchers evaluated VO2 peak (highest oxygen uptake attained during exercise) and METs as its derivative, percentage from predicted VO2 peak (based on age, sex, height, and weight), anaerobic threshold (AT, defined by the V-slope method as the level of oxygen uptake at the moment of dislinear rise in minute ventilation and CO2 output relative to VO2, reflecting the shift to anaerobic metabolism and bicarbonate buffering of increased lactic acid), O2 pulse (VO2 peak/peak heart rate), ventilatory equivalent for carbon dioxide (VE/VCO2 slope), end-tidal CO2 pressure at rest and at peak exercise (PetCO2 rest and PetCO2 peak). Patient's effort was considered substantial if the self-reported number using a 1-10 modified Borg scale was ≥ 7 points and respiratory exchange ratio (RER, defined as VCO2/VO2 ratio) was ≥1.0.
Endothelial function assessment Pulse wave characteristics were obtained using finger photopletysmography (PPG) (Angioscan-01, AngioScan-Electronics) from an infrared light sensor. The amount of light transmitted to the finger directly depends on the alterations in its blood flow. The signal obtained during PPG is displayed as a digital volume pulse (DVP) waveform. This wave usually demonstrates two deflections: an early systolic peak (a), reflecting a direct pressure wave propagation from the left ventricle to the finger, and the diastolic peak (b), that reflects backward pressure wave propagation to the aorta. The time between these two peaks (peak-to-peak time, PPT) is proportional to the subject's height. We measured large artery stiffness index (SI, a ratio between the length of aorta calculated automatically based on height to PPT), reflection index of small resistive arteries (RI, calculated as b/a x 100%), augmentation index (AI, defined as the ratio between late and early systolic pulse wave peaks, expressed as percent from the pulse pressure) and augmentation index normalized for pulse rate of 75 beats per minute (AIp75%) with regard to the fact that the heart rate has a major impact on the augmentation of pulse pressure. Endothelial function was also evaluated using occlusion index and shear rate during post-occlusive reactive hyperemia (PORH) representing the magnitude of limb reperfusion after a brief period of brachial artery occlusion. The probe was performed in the morning hours in supine position after 15 minutes of rest in a comfortable quiet warm environment according to a standardized protocol on subject preparation (fasting state, restriction of moderate-to-high physical activity, nicotine, alcohol, caffeine or other vasoactive drugs 24 hours before the probe).
Statistical analysis Microsoft Excel spreadsheet application was used for data storage and preparation for future analysis. Statistical analysis was performed using Prism 9.2.0 software. Python software was applied for multiple logistic regression models. The continuous data were expressed as a mean value (M) ± standard deviation (SD) with a 95% confidence interval (CI). Categorical variables were presented in absolute numbers and percentage and computed by using two-tailed Fischer's exact test. Normality of distribution for quantitative variables was tested using Anderson-Darling test as the first step and using Student t-test or Mann-Whitney U-test as the second step. Normality of distribution was initially evaluated as well before correlation analysis with a Pearson coefficient for normal data and with a Spearmen coefficient for non-normal data. Multiple regression models were performed considering multiple testing of hypotheses. The results of the study were presented as histograms with pairwise comparison of correlation matrices. P-value <0.05 was considered significant.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| childhood cancer survivors - the main group | – | Diagnostic Test: 12-lead ECG, hormone and lipid blood tests, echocardiography (Echo-CG), cardiopulmonary exercise testing (CPET) and pulse wave analysischildhood cancer survivals after complex management of cranial and craniospinal tumors formed the main group |
| the control group | – | Diagnostic Test: 12-lead ECG, hormone and lipid blood tests, echocardiography (Echo-CG), cardiopulmonary exercise testing (CPET) and pulse wave analysishealthy people formed the control group |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- childhood cancer survivals after complex management of cranial and craniospinal tumors formed the main group
Key inclusion criteria (5 listed)
- radiation and chemotherapy for cranial and craniospinal tumors in childhood or adolescence
- completion of the therapy at least one year before enrollment
- signed informed consent
- there were three separate types of informed consent - for adults, for minors and for their parents
- minors were signing informed consent in the presence of their parents.
Key exclusion criteria (6 listed)
- standard contraindications to exercise testing
- anemia, pregnancy
- psychiatric disease
- alcohol or drug abuse
- active malignancy
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 |
|---|---|---|
| 12-lead ECG, hormone and lipid blood tests, echocardiography (Echo-CG), cardiopulmonary exercise testing (CPET) and pulse wave analysisEchocardiography - standart protocol. Pulse wave characteristics were obtained using finger photopletysmography (PPG) (Angioscan-01, AngioScan-Electronics) from an infrared light sensor. Endothelial function was also evaluated using occlusion index and shear rate during post-occlusive reactive hyperemia (PORH). CPET was conducted on a treadmill (Intertrack 8100, Schiller, Switzerland) with a breath-by-breath algorithm of gas exchange analysis (Cardiovit CS-200 Ergo-Spiro, Schiller, Switzerland), using Bruce, modified Bruce or Naughton protocols depending on the level of physical tolerance. | Diagnostic test | childhood cancer survivors - the main group, the control group |
Primary outcome
Dyslipidemia
Time frame: At baseline and through study completion of 1 year
change сoncentration of total cholesterol >5 mmol/l, change сoncentration of LDL > 3 mmol/l, сoncentration of HDL <1,2 mmol/l, change сoncentration of TG >1,7 mmol/
endotelian dysfunction
Time frame: At baseline and through study completion of 1 year
change in endothelial function by Angioscan
change in exercise tolerance
Time frame: At baseline and through study completion of 1 year
change anaerobic threshold<14,0 ml/kg/min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- a special Abstract Supplement edition to the European Journal of Heart Failure, 2020; Vascular dysfunction and decreased exercise capacity in childhood cranial and craniospinal tumors survivors.Link provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumors of the Central Nervous System and Childhood Cancer Survivors, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 7 Dec 2022. 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 Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dyslipidemia (time frame: At baseline and through study completion of 1 year). The study lists 3 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 7 Dec 2022.