The Radiation Metabolic Signature of Patient Undergoing Radiotherapy. A Pilot Study

NCT01975558 | Completed

• 1 other identifier: 181/11
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Local radiotherapy applied in the treatment of tumors changes the metabolic profile in the exposed area and/or systemically and specific radiation biomarkers can be identified in the respective matrices. Purpose: This is a pilot study to verify in humans the results obtained from two animal models exposed to ionizing gamma-radiation. The classification of patients results from the treatment volume of radiotherapy for cancer disease. Two patient groups with breast cancer undergoing high-dose radiotherapy are selected and compared to control group of age matched healthy women.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change from baseline in radiation metabolites

  To affirm the results from animal model in radiation metabolomics in human radiotherapy treatment.

  During radiation treatment, expected to be ca. 5 weeks

Secondary Outcomes (1)

• New potential biomarkers for radiation biodosimetry

  During and after radiation treatment (at baseline, week 1,5 + 6, 8 weeks after therapy end)

Study Arms (3)

Control group A

Control group. The group will undergo blood, urine, sebum, and saliva sampling.

Biological: Sampling at baseline, one week after baseline, two weeks after baseline

Breast cancer B

Breast cancer (60 Gy). The group will undergo blood, urine, sebum, and saliva sampling within the irradiation field.

Biological: Sampling at baseline, during radiotherapy and after

Breast cancer C

Breast cancer (60 Gy). The group will undergo blood, urine, sebum, and saliva sampling outside of the irradiation field, e.g. at the arm.

Biological: Sampling at baseline, during radiotherapy and after

Interventions

Sampling at baseline, one week after baseline, two weeks after baseline BIOLOGICAL

Control group A

Sampling at baseline, during radiotherapy and after BIOLOGICAL

Breast cancer B; Breast cancer C

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Twenty patients with breast cancer. Ten healthy volunteers.

Radiotherapy: cancer treatment with total doses of more than 30 Gy, single fraction dose of at least 1.8 Gy/die. Big treatment/target volume. Age over 50 years, according to postmenopausal status. No simultaneous chemotherapy in breast cancer patients. For the control group: healthy volunteers (women), age over 50 years, according to postmenopausal status; no previous chemo - and cancer therapy.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Radio-Oncology, Bern University Hospital

Bern, 3010, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, sebum, saliva.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kristina Loessl, MD

  Dept. of Radiation Oncology, University Hospital, Inselspital Bern

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: November 4, 2013
• Study Start: June 26, 2014
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: March 2, 2020

Record last verified: 2020-02

Locations

CH (1)