Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients

Recruiting

• Conditions: Breast Neoplasms; Radiation Tolerance

• Registration Number: NCT05566613
• Lead Sponsor: Karolinska University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2022-05-09
• Study First Submitted: 2022-06-12
• Status Verified: 2022-09
• Study First Submitted QC: 2022-10-02
• Last Update Submitted: 2022-10-02
• Study First Posted: 2022-10-04
• Last Update Posted: 2022-10-04
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute radiation dermatitis grading criteria	Before and during treatment and after one year	Acute radiation dermatitis grading criteria according to the Radiation Therapy Oncology Group. Minimum value 1 and maximum value 4, higher value means a worse outcome

Secondary Outcome Measures

Name	Time	Method
Breast cancer specific Quality of life (QoL)	Before and during treatment and after one year	Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-BR23
Quality of life (QoL)	Before and during treatment and after one year	Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-C30
Cancer related fatigue Quality of life (QoL)	Before and during treatment and after one year	Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-FA12
Number of participants with heart disease	at five years	Heart disease as described in patient chart diagnosed after radiotherapy
Number of participants with lung disease	at five years	Lung disease as described in patient chart diagnosed after radiotherapy and related to the radiotherapy treatment area

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden