Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients
SENS
1 other identifier
observational
550
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 9, 2022
CompletedFirst Submitted
Initial submission to the registry
June 12, 2022
CompletedFirst Posted
Study publicly available on registry
October 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 4, 2022
September 1, 2022
2.6 years
June 12, 2022
October 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Quality of life (QoL)
Before and during treatment and after one year
Breast cancer specific Quality of life (QoL)
Before and during treatment and after one year
Cancer related fatigue Quality of life (QoL)
Before and during treatment and after one year
Number of participants with heart disease
at five years
Number of participants with lung disease
at five years
Interventions
Blood sample before and after radiotherapy and photography before radiotherapy
Eligibility Criteria
Patients receiving postoperative radiotherapy for breast cancer.
You may qualify if:
- 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
You may not qualify if:
- Ongoing infection
- Fever \>37,9 degrees Celsius
- Unable to follow study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska University Hospitallead
- Stockholm Universitycollaborator
Study Sites (1)
Karolinska University Hospital
Stockholm, 17176, Sweden
Biospecimen
Single nucleotide polymorphisms (SNPs) will be analysed
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mattias Hedman, MD PhD
Karolinska University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Radiotherapy
Study Record Dates
First Submitted
June 12, 2022
First Posted
October 4, 2022
Study Start
May 9, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
October 4, 2022
Record last verified: 2022-09