Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients (SENS)

Karolinska University Hospital

Status: Enrolling

Conditions: Radiation Tolerance; Breast Neoplasms

Treatments: Radiation: Blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT05566613

21/079

Details and patient eligibility

About

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

Full 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.

Enrollment: 550 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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