Early Ageing During Therapy in AYA Cancer Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-39
SponsorUniversity Medical Center Groningen

About this trial

Longitudinal cohort study; measurements before start of systemic therapy and one year later.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sampling

    Procedure/Surgery

    Study measurements will be performed twice and consist of blood withdrawal and physical examination (weight, height, waist-hip ratio, and blood pressure).

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: AYA cancer patients1 intervention

Trial outcomes

Primary outcomes

1

Change in senescence marker P16

determine change in senescence marker P16 between start of systemic therapy and one year later.

Time frame
at baseline and 1 year after start systemic therapy

Secondary outcomes

1

Changes in SASPs and vascular markers

Determine changes in SASPs and vascular markers

Time frame
at baseline and 1 year after start systemic therapy
2

Prevalence of classical cardiovascular risk factors (smoking, lipids, BMI, glucose)

Determine prevalence of classical cardiovascular risk factors (lipids, BMI, glucose)

Time frame
at baseline and 1 year after start systemic therapy
3

Association between treatment type and change in senescence marker P16

Determine association between treatment type and change in senescence marker P16

Time frame
at baseline and 1 year after start systemic therapy
4

Association between age and change in senescence marker P16

Determine association between age and change in senescence marker P16

Time frame
at baseline and 1 year after start systemic therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Groningen

Lead sponsor

UMCG Kanker Researchfonds

Collaborator