Age-related Changes in the Immune System and Their Impact on Elderly Breast Cancer

NCT02327572 | Completed

• 2 other identifiers: S56278 UGasthuisbergS56278
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research project aims to study this intriguing relationship between ageing and breast cancer biology, and more specifically the changes that occur within the tumor microenvironment with increasing age. Furthermore, it will focus on the link between these microenvironmental changes and organismal ageing (as measured by chronological age, geriatric evaluation of elderly patients, and circulating biomarkers of ageing), since it seems logical that age-related changes in the stromal part of a tumor (fibroblasts, immune cells, endothelial cells, fatty cells, …i.e. host cells) are due to the ageing process of the entire body. Most particularly, the amount and type of infiltrating immune cells might reflect the degree of immunosenescence of the host. More and more research points out the crucial role of the immune system in tumorigenesis and progression, and, at the same time, the immune system is one of the most affected components in the process of ageing. .

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• - Are there differences in tumor stroma, both with regard to immune infiltration and cellular senescence, between young and old patients, and between old fit and old frail patients?

  at diagnosis

Secondary Outcomes (3)

• - Does the local immune response in the tumor (amount and type of infiltrating cells) correlate with subset profile of circulating immune cells (PBMC) and immunosenescence markers in the plasma, and with clinical ageing?

  at diagnosis

• - Is there a relation between senescence markers expressed in tumor stroma (SAβ-galactosidase, heterochromatinisation, SASP) and ageing markers measured in the blood?

  at diagnosis

• - Do immune infiltration of the tumor, stromal senescence in the tumor and plasma ageing/immunosenescence profile correlate with relapse and survival (long term outcome)?

  at diagnosis

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Patients newly diagnosed with breast cancer who will undergo surgery and gave written informed consent * Group 1 : 30 patients aged 70+ Group 2 : 15 patients aged 55-65 (post-menopausal) Group 3 : 15 patients aged 35-45 (pre-menopausal) * Tumor selection : grade II/III invasive tumor, any histological type, ER-positive, HER2-negative * Tumor size ≥1.5 cm (clinical assessment: mammoechography and/or clinical examination) * Routine geriatric assessment performed prior to surgery in group 1.

You may qualify if:

• o Patients newly diagnosed with breast cancer who will undergo surgery and gave written informed consent
• Group 1 : 30 patients aged 70+ Group 2 : 15 patients aged 55-65 (post-menopausal) Group 3 : 15 patients aged 35-45 (pre-menopausal)
• Tumor selection : grade II/III invasive tumor, any histological type, ER-positive, HER2-negative
• Tumor size ≥1.5 cm (clinical assessment: mammoechography and/or clinical examination)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (two 10-mL EDTA tubes) will be collected from each patient immediately prior to surgery for assessing ageing/immunosenescence biomarkers

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• hans wildiers

  department of general medical oncology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: adjunct head of clinic

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 30, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

BE (1)