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Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients

Recruiting
18 years of age
Both
Phase N/A

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Overview

Non-randomized clinical cohort study investigating if single nucleotide polymorphism (SNP) or inflammatory markers can predict radiosensitivity in breast cancer patients receiving radiotherapy.

Description

Objectives

  1. To explore if acute radiation response can be predicted in patients, by analyzing a single nucleotide polymorphism (SNP rs1801516) sampled prior to radiotherapy.
  2. If acute radiation response can be predicted in patients, by analyzing genetic and inflammatory markers in blood sampled prior to radiotherapy.
  3. If late side effects from radiotherapy can be predicted in patients, by analyzing genetic and inflammatory markers in blood sampled before and after radiotherapy.
  4. If there is a correlation between genetic and inflammatory markers in blood and patient reported outcome measures (PROM) and quality of life (QoL).
  5. To train an algorithm to correlate the appearance of skin before radiotherapy and the extent of skin reaction to radiotherapy

Outline This study is a non-randomized clinical cohort study. Adults with breast cancer will be invited to participate in the study. Blood will be collected before start of treatment and after radiotherapy is completed. Quality of life (QoL) and symptoms will be assessed before and weekly during treatment, at the end of treatment and after one year. A total of 550 patients is expected to be recruited.

Eligibility

Inclusion criteria:

  • Patients receiving adjuvant radiotherapy for breast cancer 2,67 Gy x 15 (or a radio biologically equivalent dose)
  • > 18 years
  • Being able to read and understand patient information in Swedish
  • Signed informed consent

Exclusion criteria:

  • Ongoing infection
  • Fever >37,9 degrees Celsius
  • Unable to follow study protocol

Study details

Radiation Tolerance, Breast Neoplasms

NCT05566613

Karolinska University Hospital

25 January 2024

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