CancerNCT05062707
Early Ageing During Therapy in AYA Cancer Patients
An observational study of Cancer and Leukemia, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Longitudinal cohort study; measurements before start of systemic therapy and one year later. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer, Leukemia, Hodgkin Lymphoma
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Feb 2022to Jul 2025
- 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 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Study population: AYA patients who will start systemic treatment at the Department of Medical Oncology or Haematology of the University Medical Center Groningen are potential study participants. Patients will be informed about the study during a regular visit to the outpatient clinic or during their admission to the nursing ward. From the moment the study starts, the investigators aim to include all consecutive patients during a period of 2 years.
Who may be able to join
- Aged 18-39 years at cancer diagnosis
- Having a histologically and/or cytologically confirmed cancer diagnosis, including leukemia, (non-)Hodgkin lymphoma, testicular cancer, osteosarcoma, Ewing sarcoma, breast cancer, and cervical cancer.
- Scheduled to start systemic therapy with curative intent. Allowed treatments (concurrent or sequential) are: surgery, radiotherapy, chemotherapy, antibodies.
Who cannot join
- patients who are not able to understand the patient information letter and informed consent form
- patients who will be treated with immune checkpoint inhibitors or targeted therapy with inhibitors of angiogenesis
- patients who have been treated with systemic therapy or radiotherapy for a previous malignancy (exceptions: in situ carcinoma of the cervix or uterus and adequately treated basal and squamous cell carcinoma of the skin).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
J. Nuver, MD, PhD, +31 50 361 2821, j.nuver@umcg.nl
J. Nuver, MD, PhD
About this study
Official title: Longitudinal Assessment of Therapy-related Early Ageing in Adolescent and Young Adult (AYA) Cancer Patients
Longitudinal cohort study; measurements before start of systemic therapy and one year later.
Read the detailed description
Rationale:
Compared with survivors of childhood cancer, there is sparse knowledge about the long-term morbidity and mortality of adolescent and young adult (AYA) cancer patients, who are diagnosed at age 18-39 and have an 80% chance to survive. Following cancer treatment, many cancer survivors, including those at AYA age, have an increased risk of cardiovascular disease. Early ageing has been described in paediatric and certain adult cancer survivor populations. One of the responsible mechanisms behind biological ageing is cellular senescence, characterized by a stable arrest of the cell cycle which occurs in response to stress and damage. In all organisms the number of senescent cells increases with age and senescence has been associated with age-related diseases, like atherosclerosis and Alzheimer. Early ageing as a result of intensive cancer treatment with systemic therapy and radiation may result in early cardiovascular disease. However, information about senescence, early vascular ageing and related patient and tumour characteristics is missing for AYAs.
Objective:
to determine markers related to early ageing and senescence in AYA cancer patients before and after systemic therapy, in order to assess treatment-related early vascular ageing and associated tumour and patient characteristics.
Study design:
Longitudinal cohort study; measurements before start of systemic therapy and one year later.
Study population:
Patients aged 18-39 years, with a first histological and/or cytological diagnosis of a haematological or solid malignancy, scheduled to start systemic therapy with curative intent.
Main study parameters/endpoints:
Primary endpoint is change in senescence marker P16 between start of systemic therapy and one year later. Secondary endpoints are: changes in senescence-associated secretory phenotype (SASP) and vascular markers; prevalence of classical cardiovascular risk factors (smoking, lipids, body mass index (BMI), glucose); tumour (treatment) and patient (age, sex, pre-existent cardiometabolic status) factors related to the changes in senescence, SASP and cardiovascular risk factors.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Study measurements will be performed twice and consist of blood withdrawal and physical examination (weight, height, waist-hip ratio, and blood pressure).
- Conditions
- Cancer, Leukemia, Hodgkin Lymphoma, Testicular Cancer, Osteosarcoma, Ewing Sarcoma
- Being tested
- Blood sampling
- Medical subject headings
- Neoplasms, Leukemia, Hodgkin Disease, Testicular Neoplasms, Osteosarcoma, Sarcoma, Ewing, Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Study measurements will be performed twice and consist of blood withdrawal and physical examination (weight, height, waist-hip ratio, and blood pressure).
| Study group | Role | What they receive |
|---|---|---|
| AYA cancer patients | Patients aged 18-39 years, with a first histological and/or cytological diagnosis of a haematological or solid malignancy, scheduled to start systemic therapy with curative intent. Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in senescence marker P16
determine change in senescence marker P16 between start of systemic therapy and one year later.
Measured: at baseline and 1 year after start systemic therapy
Secondary outcomes (5)
Changes in SASPs and vascular markers
Determine changes in SASPs and vascular markers
Measured: at baseline and 1 year after start systemic therapy
Prevalence of classical cardiovascular risk factors (smoking, lipids, BMI, glucose)
Determine prevalence of classical cardiovascular risk factors (lipids, BMI, glucose)
Measured: at baseline and 1 year after start systemic therapy
Association between treatment type and change in senescence marker P16
Determine association between treatment type and change in senescence marker P16
Measured: at baseline and 1 year after start systemic therapy
Association between age and change in senescence marker P16
Determine association between age and change in senescence marker P16
Measured: at baseline and 1 year after start systemic therapy
Associations between senescence, inflammation, and cardiovascular risk factors
Determine associations between senescence, inflammation, and cardiovascular risk factors
Measured: at baseline and 1 year after start systemic therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start10 Feb 2022
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- UMCG Kanker Researchfonds
- Responsible party
- Sponsor
- Investigators
- J. Nuver, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062707
- Sponsor's protocol ID
- 202100484
- Status last verified
- May 2025
- First submitted
- 21 Sep 2021
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Therapy-related Early Ageing in Adolescent and Young Adult (AYA) Cancer Patients
- ClinicalTrials.gov ID
- NCT05062707
- Acronym / sponsor ID
- 202100484
- Conditions
- Cancer, Leukemia, Hodgkin Lymphoma, Testicular Cancer, Osteosarcoma, Ewing Sarcoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- UMCG Kanker Researchfonds
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 30 Sep 2021 (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.
Longitudinal cohort study; measurements before start of systemic therapy and one year later.
Detailed description
Rationale:
Compared with survivors of childhood cancer, there is sparse knowledge about the long-term morbidity and mortality of adolescent and young adult (AYA) cancer patients, who are diagnosed at age 18-39 and have an 80% chance to survive. Following cancer treatment, many cancer survivors, including those at AYA age, have an increased risk of cardiovascular disease. Early ageing has been described in paediatric and certain adult cancer survivor populations. One of the responsible mechanisms behind biological ageing is cellular senescence, characterized by a stable arrest of the cell cycle which occurs in response to stress and damage. In all organisms the number of senescent cells increases with age and senescence has been associated with age-related diseases, like atherosclerosis and Alzheimer. Early ageing as a result of intensive cancer treatment with systemic therapy and radiation may result in early cardiovascular disease. However, information about senescence, early vascular ageing and related patient and tumour characteristics is missing for AYAs.
Objective:
to determine markers related to early ageing and senescence in AYA cancer patients before and after systemic therapy, in order to assess treatment-related early vascular ageing and associated tumour and patient characteristics.
Study design:
Longitudinal cohort study; measurements before start of systemic therapy and one year later.
Study population:
Patients aged 18-39 years, with a first histological and/or cytological diagnosis of a haematological or solid malignancy, scheduled to start systemic therapy with curative intent.
Main study parameters/endpoints:
Primary endpoint is change in senescence marker P16 between start of systemic therapy and one year later. Secondary endpoints are: changes in senescence-associated secretory phenotype (SASP) and vascular markers; prevalence of classical cardiovascular risk factors (smoking, lipids, body mass index (BMI), glucose); tumour (treatment) and patient (age, sex, pre-existent cardiometabolic status) factors related to the changes in senescence, SASP and cardiovascular risk factors.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Study measurements will be performed twice and consist of blood withdrawal and physical examination (weight, height, waist-hip ratio, and blood pressure).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AYA cancer patients | – | Procedure: Blood samplingPatients aged 18-39 years, with a first histological and/or cytological diagnosis of a haematological or solid malignancy, scheduled to start systemic therapy with curative intent. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- AYA patients who will start systemic treatment at the Department of Medical Oncology or Haematology of the University Medical Center Groningen are potential study participants. Patients will be informed about the study during a regular visit to the outpatient clinic or during their admission to the nursing ward. From the moment the study starts, the investigators aim to include all consecutive patients during a period of 2 years.
Key inclusion criteria (3 listed)
- Aged 18-39 years at cancer diagnosis
- Having a histologically and/or cytologically confirmed cancer diagnosis, including leukemia, (non-)Hodgkin lymphoma, testicular cancer, osteosarcoma, Ewing sarcoma, breast cancer, and cervical cancer.
- Scheduled to start systemic therapy with curative intent. Allowed treatments (concurrent or sequential) are: surgery, radiotherapy, chemotherapy, antibodies.
Key exclusion criteria (3 listed)
- patients who are not able to understand the patient information letter and informed consent form
- patients who will be treated with immune checkpoint inhibitors or targeted therapy with inhibitors of angiogenesis
- patients who have been treated with systemic therapy or radiotherapy for a previous malignancy (exceptions: in situ carcinoma of the cervix or uterus and adequately treated basal and squamous cell carcinoma of the skin).
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 |
|---|---|---|
| Blood samplingStudy measurements will be performed twice and consist of blood withdrawal and physical examination (weight, height, waist-hip ratio, and blood pressure). | Procedure or surgery | AYA cancer patients |
Primary outcome
Change in senescence marker P16
Time frame: at baseline and 1 year after start systemic therapy
determine change in senescence marker P16 between start of systemic therapy and one year later.
5 secondary outcomes
Changes in SASPs and vascular markers
Time frame: at baseline and 1 year after start systemic therapy
Prevalence of classical cardiovascular risk factors (smoking, lipids, BMI, glucose)
Time frame: at baseline and 1 year after start systemic therapy
Association between treatment type and change in senescence marker P16
Time frame: at baseline and 1 year after start systemic therapy
Association between age and change in senescence marker P16
Time frame: at baseline and 1 year after start systemic therapy
Associations between senescence, inflammation, and cardiovascular risk factors
Time frame: at baseline and 1 year after start systemic 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 13 May 2025.
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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.
J. Nuver, MD, PhD principal investigator
University Medical Center Groningen
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 Cancer and Leukemia, run by University Medical Center Groningen at 1 site in Netherlands.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 May 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 Netherlands. 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?
Contact J. Nuver, MD, PhD (+31 50 361 2821, j.nuver@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in senescence marker P16 (time frame: at baseline and 1 year after start systemic therapy). 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 13 May 2025.