Clincosm LogoSign in Get a demo

SENS: Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients

Sponsor
Karolinska University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05566613
Collaborator
Stockholm University (Other)
550
Enrollment
1
Location
31.8
Anticipated Duration (Months)
17.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Blood sample

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 Design

Study Type:
Observational
Anticipated Enrollment :
550 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prediction of Individual Radiosensitivity During Radiotherapy for Breast Cancer Patients, the Role of Genetic and Inflammatory Markers
Actual Study Start Date :
May 9, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Outcome Measures

Primary Outcome Measures

  1. Acute radiation dermatitis grading criteria [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

Secondary Outcome Measures

  1. Quality of life (QoL) [Before and during treatment and after one year]

    Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-C30

  2. Breast cancer specific Quality of life (QoL) [Before and during treatment and after one year]

    Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-BR23

  3. Cancer related fatigue Quality of life (QoL) [Before and during treatment and after one year]

    Quality of life determined by European Organisation for Research and Treatment of Cancer questionnaire QLQ-FA12

  4. Number of participants with heart disease [at five years]

    Heart disease as described in patient chart diagnosed after radiotherapy

  5. Number of participants with lung disease [at five years]

    Lung disease as described in patient chart diagnosed after radiotherapy and related to the radiotherapy treatment area

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska University Hospital Stockholm Sweden 17176

Sponsors and Collaborators

  • Karolinska University Hospital
  • Stockholm University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mattias Hedman, Head of Radiotherapy, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT05566613
Other Study ID Numbers:
  • 21/079
First Posted:
Oct 4, 2022
Last Update Posted:
Oct 4, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Oct 4, 2022