Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients (SENS)

October 2, 2022 updated by: Mattias Hedman, Karolinska University Hospital

Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients, the Role of Genetic and Inflammatory Markers

Non-randomized clinical cohort study investigating if single nucleotide polymorphism (SNP) or inflammatory markers can predict radiosensitivity in breast cancer patients receiving radiotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving postoperative radiotherapy for breast cancer.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute radiation dermatitis grading criteria
Time Frame: Before and during treatment and after one year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (QoL)
Time Frame: Before and during treatment and after one year
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)
Time Frame: Before and during treatment and after one year
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)
Time Frame: Before and during treatment and after one year
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
Time Frame: at five years
Heart disease as described in patient chart diagnosed after radiotherapy
at five years
Number of participants with lung disease
Time Frame: at five years
Lung disease as described in patient chart diagnosed after radiotherapy and related to the radiotherapy treatment area
at five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Stockholm University

Investigators

  • Principal Investigator: Mattias Hedman, MD PhD, Karolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

June 12, 2022

First Submitted That Met QC Criteria

October 2, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 2, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21/079

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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