Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05062707 |
| Other study ID # |
202100484 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 10, 2022 |
| Est. completion date |
July 2025 |
Study information
| Verified date |
November 2023 |
| Source |
University Medical Center Groningen |
| Contact |
J. Nuver, MD, PhD |
| Phone |
+31 50 361 2821 |
| Email |
j.nuver[@]umcg.nl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Longitudinal cohort study; measurements before start of systemic therapy and one year later.
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).
