Breast Neoplasms Clinical Trial
— SENSOfficial title:
Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients, the Role of Genetic and Inflammatory Markers
NCT number | NCT05566613 |
Other study ID # | 21/079 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 9, 2022 |
Est. completion date | December 31, 2024 |
Non-randomized clinical cohort study investigating if single nucleotide polymorphism (SNP) or inflammatory markers can predict radiosensitivity in breast cancer patients receiving radiotherapy.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska University Hospital | Stockholm University |
Sweden,
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 |
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