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.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is change in senescence marker P16 between start of systemic
therapy and one year later.
Secondary outcome
Secondary endpoints are:
Changes in senescence-associated secretory phenotype (SASP) and vascular
markers; prevalence of classical cardiovascular risk factors (lipids, BMI,
glucose); tumour (treatment), patient (age, sex, pre-existent cardiometabolic
status), and sociodemographic (lifestyle) factors related to the changes in
senescence, SASP and cardiovascular risk factors.
Background summary
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.
Study 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 burden and risks
Study measurements will be performed twice and consist of blood withdrawal and
physical examination (including weight, height, waist-hip ratio, and blood
pressure).
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- 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.
Exclusion criteria
- who are not able to understand the patient information letter and informed
consent form
- who will be treated with immune checkpoint inhibitors or targeted therapy
with inhibitors of angiogenesis
- 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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78186.042.21 |
| Other | volgt |