Early Ageing During Therapy in AYA Cancer Patients

Sponsor
University Medical Center Groningen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05062707
Collaborator
UMCG Kanker Researchfonds (Other)
120
Enrollment
1
Location
24
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Blood sampling

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

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Longitudinal Assessment of Therapy-related Early Ageing in Adolescent and Young Adult (AYA) Cancer Patients
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

ArmIntervention/Treatment
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.

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

Outcome Measures

Primary Outcome Measures

  1. Change in senescence marker P16 [at baseline and 1 year after start systemic therapy]

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

Secondary Outcome Measures

  1. Changes in SASPs and vascular markers [at baseline and 1 year after start systemic therapy]

    Determine changes in SASPs and vascular markers

  2. Prevalence of classical cardiovascular risk factors (smoking, lipids, BMI, glucose) [at baseline and 1 year after start systemic therapy]

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

  3. Association between treatment type and change in senescence marker P16 [at baseline and 1 year after start systemic therapy]

    Determine association between treatment type and change in senescence marker P16

  4. Association between age and change in senescence marker P16 [at baseline and 1 year after start systemic therapy]

    Determine association between age and change in senescence marker P16

  5. Associations between senescence, inflammation, and cardiovascular risk factors [at baseline and 1 year after start systemic therapy]

    Determine associations between senescence, inflammation, and cardiovascular risk factors

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 39 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  • 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).

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University Medical Center GroningenGroningenNetherlands9713 GZ

Sponsors and Collaborators

  • University Medical Center Groningen
  • UMCG Kanker Researchfonds

Investigators

  • Principal Investigator: J. Nuver, MD, PhD, University Medical Center Groningen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
J. Nuver, Principal investigator, University Medical Center Groningen
ClinicalTrials.gov Identifier:
NCT05062707
Other Study ID Numbers:
  • 202100484
First Posted:
Sep 30, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021