Clinical trial NCT05566613: Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients
Official title: Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients, the Role of Genetic and Inflammatory Markers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiation Tolerance
Breast Neoplasms
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Stockholm University
First posted: 2022-10-04
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving postoperative radiotherapy for breast cancer.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute radiation dermatitis grading criteria
timeFrame: Before and during treatment and after one year
Secondary outcomes:
measure: Quality of life (QoL)
timeFrame: Before and during treatment and after one year
measure: Breast cancer specific Quality of life (QoL)
timeFrame: Before and during treatment and after one year
measure: Cancer related fatigue Quality of life (QoL)
timeFrame: Before and during treatment and after one year
measure: Number of participants with heart disease
timeFrame: at five years
measure: Number of participants with lung disease
timeFrame: at five years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Mattias Hedman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: