Clinical trial · Observational
The Radiation Metabolic Signature of Patient Undergoing Radiotherapy. A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sampling at baseline, during radiotherapy and after | Biological | — | UNRESOLVED |
| Sampling at baseline, one week after baseline, two weeks after baseline | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Control group A
- description
- Control group. The group will undergo blood, urine, sebum, and saliva sampling.
- interventionNames
- Biological: Sampling at baseline, one week after baseline, two weeks after baseline
- label
- Breast cancer B
- description
- Breast cancer (60 Gy). The group will undergo blood, urine, sebum, and saliva sampling within the irradiation field.
- interventionNames
- Biological: Sampling at baseline, during radiotherapy and after
- label
- Breast cancer C
- description
- Breast cancer (60 Gy). The group will undergo blood, urine, sebum, and saliva sampling outside of the irradiation field, e.g. at the arm.
- interventionNames
- Biological: Sampling at baseline, during radiotherapy and after
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available