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Trial Title:
Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients
NCT ID:
NCT05566613
Condition:
Radiation Tolerance
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
Blood sample
Description:
Blood sample before and after radiotherapy and photography before radiotherapy
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.
Criteria for eligibility:
Study pop:
Patients receiving postoperative radiotherapy for breast cancer.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Karolinska University Hospital
Address:
City:
Stockholm
Zip:
17176
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Mattias Hedman, MD PhD
Phone:
+46812370000
Email:
mattias.hedman@regionstockholm.se
Start date:
May 9, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Karolinska University Hospital
Agency class:
Other
Collaborator:
Agency:
Stockholm University
Agency class:
Other
Source:
Karolinska University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05566613
