Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients

Breast Neoplasms Clinical Trial

— SENS  

Official title:

Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients, the Role of Genetic and Inflammatory Markers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05566613
• Other study ID #: 21/079
• Status: Recruiting
• Start date: May 9, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2022
• Source: Karolinska University Hospital
• Contact: Mattias Hedman, MD PhD
• Phone: +46812370000
• Email: mattias.hedman[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Radiation Tolerance

Intervention

Radiation:
• Blood sample
Blood sample before and after radiotherapy and photography before radiotherapy

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Stockholm University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute radiation dermatitis grading criteria	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	Before and during treatment and after one year
Secondary	Quality of life (QoL)	Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-C30	Before and during treatment and after one year
Secondary	Breast cancer specific Quality of life (QoL)	Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-BR23	Before and during treatment and after one year
Secondary	Cancer related fatigue Quality of life (QoL)	Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-FA12	Before and during treatment and after one year
Secondary	Number of participants with heart disease	Heart disease as described in patient chart diagnosed after radiotherapy	at five years
Secondary	Number of participants with lung disease	Lung disease as described in patient chart diagnosed after radiotherapy and related to the radiotherapy treatment area	at five years