Childhood and Adolescence Cancer (Survivors and Deceased)CVSSNCT02181049
Cardiac and Vascular Late Sequelae in Long-term Survivors of Childhood Cancer (CVSS)
An observational study of Childhood and Adolescence Cancer (Survivors and Deceased), run by CVSS study at 1 site in Germany.
Trial summary
Due to remarkable advances in childhood cancer therapy the 10-year survival rate increased to over 80% and late sequelae come to the fore. Childhood cancer survivors (CCS) suffer from significant excess in mortality risk associated with treatment-related complications at least for 25 years after the initial cancer… Read more about this study
- Who is it for?
- Ages 24 to 49 years
- Conditions the study is for
- Childhood and Adolescence Cancer (Survivors and Deceased)
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Oct 2028
- Phase
- Observational
- 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 24 to 49 years
- All sexes
- Adult
Study population: Survivors of a oncological disease according to ICCC-3 aged <15 years at diagnosis, diagnosed 1980-1990 while resident in Germany
Who may be able to join
- Survivors of oncological disease according to ICCC-3 aged <15 years at diagnosis, diagnosed 1980-1990 while resident in Germany
- Declaration of consent for storage of personal data at GCCR
Who cannot join
- Patient has refused contact with GCCR
- Current address not available
- Second malignant neoplasm
- Diagnosis Morbus Hodgkin
- Diagnosis WILMS tumor in 1990
- Former treating center recommends exclusion
- Insufficient knowledge of German language
- Inability to travel to the study center and participate in the examinations
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center of the Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Cardiac and Vascular Late Sequelae in Long-term Survivors of Childhood Cancer (CVSS): a Multidisciplinary Clinical, Epidemiological and Genetic Approach
Due to remarkable advances in childhood cancer therapy the 10-year survival rate increased to over 80% and late sequelae come to the fore. Childhood cancer survivors (CCS) suffer from significant excess in mortality risk associated with treatment-related complications at least for 25 years after the initial cancer diagnosis. In particular, the prevalence of cardiovascular disease seems to be elevated compared to the general population. The CVSS study is a multi-disciplinary cooperation project between the Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI) and the German Childhood Cancer Registry (GCCR), the Preventive Cardiology and Preventive Medicine and the Pediatric Hematology and Oncology all at the University Medical Center of the Johannes Gutenberg University Mainz. The central element is a thorough clinical cardiovascular examination of all patients, which permits detecting subclinical disease. Therapy data will be extracted retrospectively from various sources. The study intends to describe the current situation of a cohort of approximately 1000 CCS in Germany aged 24 to 49 years with respect to cardiovascular health. The role of risk factors (treatment related and classic cardiovascular risk factors), as well as related predisposing genetic factors is investigated. The results will contribute to recommendations to improve follow-up care.
- Keywords
- Childhood cancer survivors, Cardiac, Vascular, Cardiovascular, Late-sequelae
- Medical subject headings
- Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure
Measured: up to 35 years after exposure to childhood cancer therapy
Hypertension
Measured: up to 35 years after exposure to childhood cancer therapy
Secondary outcomes (3)
Myocardial infarction
Measured: up to 35 years after exposure to childhood cancer therapy
Late-occurring stroke
"late" is defined as 5 years or more after diagnosis of cancer
Measured: up to 35 years after exposure to childhood cancer therapy
Carotid artery disease
Measured: up to 35 years after exposure to childhood cancer therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2018
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood and Adolescence Cancer (Survivors and Deceased)Studies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- CVSS study
- Sponsor type
- University, hospital or other
- Collaborators
- Univ. Prof. Dr. med. Joerg Faber, Center for Pediatrics, Hematology, Oncology and Hemostaseology, Univ. Prof. Dr. med. Philipp S. Wild, MSc, Preventive Cardiology and Preventive Medicine, Center for Cardiology, Clinical Epidemiology, CTH, Dr. oec. troph. Hiltrud Merzenich, Insitute for Medical Biometry, Epidemiology and Informatics (IMBEI)
- Responsible party
- Sponsor-investigator, CVSS study, Johannes Gutenberg University Mainz
- Investigators
- Joerg Faber, Univ.-Prof. Dr. med., Principal investigator, Center for Pediatrics, Pediatric Hematology, Oncology and Hemostaseology, University Medical Center of the Johannes Gutenberg University MainzPhilipp S Wild, Univ.-Prof. Dr. med. MSc, Principal investigator, Preventive Cardiology and Preventive Medicine, Center for Cardiology, Clinical Epidemiology, Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University MainzHiltrud Merzenich, Dr. oec. troph., Principal investigator, Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center of the Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181049
- Sponsor's protocol ID
- CVSS-study
- Acronym
- CVSS
- Status last verified
- Mar 2024
- First submitted
- 27 Jun 2014
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Arnold N, Merzenich H, Wingerter A, Schulz A, Schneider A, Prochaska JH, Gobel S, Neu MA, Henninger N, Panova-Noeva M, Eckerle S, Spix C, Schmidtmann I, Lackner KJ, Beutel ME, Pfeiffer N, Munzel T, Faber J, Wild PS. Promotion of Arterial Stiffness by Childhood Cancer and Its Characteristics in Adult Long-Term Survivors. J Am Heart Assoc. 2021 Feb;10(5):e015609. doi: 10.1161/JAHA.119.015609. Epub 2021 Feb 24.
PubMed 33624513
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac and Vascular Late Sequelae in Long-term Survivors of Childhood Cancer (CVSS): a Multidisciplinary Clinical, Epidemiological and Genetic Approach
- ClinicalTrials.gov ID
- NCT02181049
- Acronym / sponsor ID
- CVSS / CVSS-study
- Keywords
- Childhood cancer survivors, Cardiac, Vascular, Cardiovascular, Late-sequelae
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- CVSS studyUniversity, hospital or other
- Collaborators
- Univ. Prof. Dr. med. Joerg Faber, Center for Pediatrics, Hematology, Oncology and Hemostaseology, Univ. Prof. Dr. med. Philipp S. Wild, MSc, Preventive Cardiology and Preventive Medicine, Center for Cardiology, Clinical Epidemiology, CTH, Dr. oec. troph. Hiltrud Merzenich, Insitute for Medical Biometry, Epidemiology and Informatics (IMBEI)
- Study start
- Oct 2013 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2028 (estimated)
- First posted
- 3 Jul 2014 (estimated)
- 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.
Due to remarkable advances in childhood cancer therapy the 10-year survival rate increased to over 80% and late sequelae come to the fore. Childhood cancer survivors (CCS) suffer from significant excess in mortality risk associated with treatment-related complications at least for 25 years after the initial cancer diagnosis. In particular, the prevalence of cardiovascular disease seems to be elevated compared to the general population. The CVSS study is a multi-disciplinary cooperation project between the Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI) and the German Childhood Cancer Registry (GCCR), the Preventive Cardiology and Preventive Medicine and the Pediatric Hematology and Oncology all at the University Medical Center of the Johannes Gutenberg University Mainz. The central element is a thorough clinical cardiovascular examination of all patients, which permits detecting subclinical disease. Therapy data will be extracted retrospectively from various sources. The study intends to describe the current situation of a cohort of approximately 1000 CCS in Germany aged 24 to 49 years with respect to cardiovascular health. The role of risk factors (treatment related and classic cardiovascular risk factors), as well as related predisposing genetic factors is investigated. The results will contribute to recommendations to improve follow-up care.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 24 to 49 years
- Sex
- All
- Age groups
- Adult
- Study population
- Survivors of a oncological disease according to ICCC-3 aged <15 years at diagnosis, diagnosed 1980-1990 while resident in Germany
Key inclusion criteria (2 listed)
- Survivors of oncological disease according to ICCC-3 aged <15 years at diagnosis, diagnosed 1980-1990 while resident in Germany
- Declaration of consent for storage of personal data at GCCR
Key exclusion criteria (8 listed)
- Patient has refused contact with GCCR
- Current address not available
- Second malignant neoplasm
- Diagnosis Morbus Hodgkin
- Diagnosis WILMS tumor in 1990
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart failure
Time frame: up to 35 years after exposure to childhood cancer therapy
Hypertension
Time frame: up to 35 years after exposure to childhood cancer therapy
3 secondary outcomes
Myocardial infarction
Time frame: up to 35 years after exposure to childhood cancer therapy
Late-occurring stroke
Time frame: up to 35 years after exposure to childhood cancer therapy
Carotid artery disease
Time frame: up to 35 years after exposure to childhood cancer therapy
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 6 Mar 2024.
- Derived from this study: PubMed 33624513Arnold N, Merzenich H, Wingerter A, Schulz A, Schneider A, Prochaska JH, Gobel S, Neu MA, Henninger N, Panova-Noeva M, Eckerle S, Spix C, Schmidtmann I, Lackner KJ, Beutel ME, Pfeiffer N, Munzel T, Faber J, Wild PS. Promotion of Arterial Stiffness by Childhood Cancer and Its Characteristics in Adult Long-Term Survivors. J Am Heart Assoc. 2021 Feb;10(5):e015609. doi: 10.1161/JAHA.119.015609. Epub 2021 Feb 24.
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.
Joerg Faber, Univ.-Prof. Dr. med. principal investigator
Center for Pediatrics, Pediatric Hematology, Oncology and Hemostaseology, University Medical Center of the Johannes Gutenberg University Mainz
Philipp S Wild, Univ.-Prof. Dr. med. MSc principal investigator
Preventive Cardiology and Preventive Medicine, Center for Cardiology, Clinical Epidemiology, Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University Mainz
Hiltrud Merzenich, Dr. oec. troph. principal investigator
Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center of the Johannes Gutenberg University Mainz
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 Childhood and Adolescence Cancer (Survivors and Deceased), run by CVSS study at 1 site in Germany.
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 2 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2024. 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 Germany. 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?
Heart failure (time frame: up to 35 years after exposure to childhood cancer therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02181049, which also lists 1 linked publication.
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 6 Mar 2024.