Early Ageing During Therapy in AYA Cancer Patients

NCT05062707 | Recruiting

• 1 other identifier: 202100484
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer; Leukemia; Hodgkin Lymphoma; Testicular Cancer; Osteosarcoma; Ewing Sarcoma; Breast Cancer; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Change in senescence marker P16

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

  at baseline and 1 year after start systemic therapy

Secondary Outcomes (5)

• Changes in SASPs and vascular markers

  at baseline and 1 year after start systemic therapy

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

  at baseline and 1 year after start systemic therapy

• Association between treatment type and change in senescence marker P16

  at baseline and 1 year after start systemic therapy

• Association between age and change in senescence marker P16

  at baseline and 1 year after start systemic therapy

• Associations between senescence, inflammation, and cardiovascular risk factors

  at baseline and 1 year after start systemic therapy

Study Arms (1)

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

Interventions

Blood sampling PROCEDURE

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

AYA cancer patients

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Medical Center Groningen: lead
• UMCG Kanker Researchfonds: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fasting blood samples (65 ml in total) will be drawn to measure circulating senescence marker P16 (in circulating CD3+ (cluster of differentiation 3+) T-lymphocytes), markers of the SASP (IL-6, IL-8, VEGF (vascular endothelial growth factor) ), biochemical markers for vascular damage (von Willebrand Factor, albuminuria, coagulation markers (i.e.FVIII, fibrinogen, Plasminogen Activator inhibitor -1), high sensitivity C-reactive protein (hs-CRP), NT-proBNP (Brain Natriuretic Peptide), galectin-3, GDF-15 (Growth/Differentiation Factor-15)), and the cardiovascular risk profile (total cholesterol, triglycerides, HDL-cholesterol (high-density lipoprotein), LDL-cholesterol (low density lipoprotein); glucose, insulin, and HbA1c). The investigators will also isolate genomic DNA and RNA from full blood samples to assess SNP (single nucleotide polymorphism)-array and methylation profile as a measure for biological age.

MeSH Terms

Conditions

Neoplasms; Leukemia; Hodgkin Disease; Testicular Neoplasms; Osteosarcoma; Sarcoma, Ewing; Breast Neoplasms; Uterine Cervical Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• J. Nuver, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

J. Nuver, MD, PhD

CONTACT

+31 50 361 2821; j.nuver@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: February 10, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

NL (1)