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| Name | Class |
|---|---|
| Stockholm University | OTHER |
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Non-randomized clinical cohort study investigating if single nucleotide polymorphism (SNP) or inflammatory markers can predict radiosensitivity in breast cancer patients receiving radiotherapy.
Objectives
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Radiation | Blood sample before and after radiotherapy and photography before radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Breast cancer specific Quality of life (QoL) |
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Inclusion criteria:
Exclusion criteria:
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Patients receiving postoperative radiotherapy for breast cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mattias Hedman, MD PhD | Contact | +46812370000 | mattias.hedman@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Mattias Hedman, MD PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Stockholm | 17176 | Sweden |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Single nucleotide polymorphisms (SNPs) will be analysed
Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-BR23
| Before and during treatment and after one year |
| 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 |
| Number of participants with heart disease | Heart disease as described in patient chart diagnosed after radiotherapy | at five years |
| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |