Adjuvant Radiotherapy on Circulating Cells in Breast Cancer Patients

NCT04002570 | Completed

• 1 other identifier: CirculatingCellsBreast-RT
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Radiation applied to the preserved breast during radiotherapy treatment activates numerous molecular cascades in tumor bed adjacent cells causing an inflammatory state. During this process, pre-clinical studies demonstrated CD11b + and CD11b+cKit+cells mobilization in the blood. These cells are involved in numerous processes during tumor progression/control and metastases development. The expected results in clinical setting allow us to investigate the development of innovative therapeutic and monitoring strategies. The clinical repercussions would consist in identifying new predictive and prognostic targets in breast cancer.

Conditions

Breast Cancer

Keywords

breast cancer; circulating bone marrow-derived cells; circulating immune cells; radiotherapy; conservative treatment; disease control

Outcome Measures

Primary Outcomes (3)

• the frequency of CD11b⁺cKit⁺ cells in peripheral blood and/or gene expression in circulating CD11b⁺ cells

  validate the hypothesis that adjuvant radiotherapy in breast cancer modulates the frequency of CD11b⁺cKit⁺ cells in peripheral blood and / or gene expression in circulating CD11b⁺ cells, evaluating their trend at different time points compared to radiotherapy treatment.

  pre surgery

• the frequency of CD11b⁺cKit⁺ cells in peripheral blood and/or gene expression in circulating CD11b⁺ cells

  validate the hypothesis that adjuvant radiotherapy in breast cancer modulates the frequency of CD11b⁺cKit⁺ cells in peripheral blood and / or gene expression in circulating CD11b⁺ cells, evaluating their trend at different time points compared to radiotherapy treatment.

  pre radiotherapy

• the frequency of CD11b⁺cKit⁺ cells in peripheral blood and/or gene expression in circulating CD11b⁺ cells

  validate the hypothesis that adjuvant radiotherapy in breast cancer modulates the frequency of CD11b⁺cKit⁺ cells in peripheral blood and / or gene expression in circulating CD11b⁺ cells, evaluating their trend at different time points compared to radiotherapy treatment.

  week 6 of radiotherapy

Secondary Outcomes (1)

• radiotherapy alters in a potentially predictive way the frequency of CD11b⁺cKit⁺ cells in peripheral blood

  week 12-14 (fu)

Study Arms (3)

GROUP I/GROUP I bis

20 breast cancer patients who performed radiotherapy treatment

Other: blood samples collection

GROUP II

maximum 10 patients who performed radiotherapy and chemotherapy and/or immunotherapy and/or neo-adjuvant hormone therapy or/and adjuvant immunotherapy/hormone therapy.

Other: blood samples collection

CONTROLS GROUP

healthy women with +/- 5 years compared to breast cancer patients age

Other: blood samples collection

Interventions

blood samples collection OTHER

blood samples collection are performed at 4 different timepoints: preop, pre rt, week 6 rt, week 12-14 (fu) for GROUP I and GROUP II; blood samples collection are performed at 3 different timepoints: pre rt, week 6 rt, week 12-14 (fu) for GROUP I bis; blood samples collection are performed just once for control GROUP.

CONTROLS GROUP; GROUP I/GROUP I bis; GROUP II

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients performing treatments for breast cancer

You may qualify if:

• breast cancer diagnosis bioptically proven with pre-operative clinical stage cT1-4, N0-1, M0;
• patients who are candidates for conservative surgery (tumorectomy / quadrantectomy +/- lymphadenectomy or sentinel lymph node) or patients already undergoing conservative surgery;
• patients who are candidates for an adjuvant mammary radiotherapy treatment +/- adjuvant or neoadjuvant chemotherapy due to a triple negative or a high ki67 value that has indicated it;
• understanding of the Italian language for the Coordinating Center, understanding of the French language for the satellite center.

You may not qualify if:

• previous mastectomy surgery;
• concomitant cancer diseases;
• previous chemo / radiotherapy treatments in the last three years.

Sponsors & Collaborators

• Clinica Luganese Moncucco: lead
• Curzio Rüegg, MD, Head of Department, University of Fribourg: collaborator
• Swiss National Science Foundation: collaborator
• Tsoutsou Pelagia MD, Head of Radation Therapy Department: collaborator

Study Sites (1)

Clinica Luganese Moncucco

Lugano, Canton Ticino, 6900, Switzerland

Location

Related Publications (16)

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Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Alessandra Franzetti Pellanda, MD

  Clinica Luganese Moncucco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Radiation Therapy

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 28, 2019
• Study Start: October 25, 2015
• Primary Completion: September 15, 2020
• Study Completion: December 30, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

CH (1)