Clinical trial · Observational
A Study to Develop Molecular Integrated Predictive Models of Breast Radio-toxicity (Precise-RTox)
An Observational Study to Develop Molecular Integrated Predictive Models of Breast Radio-toxicity (Precise-RTox)
- 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)
Breast radiation treatment is burdened by acute and chronic toxicities, in most cases mild. However, considering the excellent life expectancy of patients with breast cancer, maintaining a low toxicity profile is of primary importance in order to guarantee a satisfactory quality of life. The definition of the molecular and genetic variables related to radiotoxicity and their integration into predictive molecular signatures may allow the risk of toxicity to be individualized. This would provide the clinician with a useful tool in order to personalize the radiation treatment, thus being able to choose the best technique or schedule for each patient.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Generation of a predictive model for actinic fibrosis.
- timeFrame
- up to 2 years after start of treatment
- description
- Identification of a predictive model of actinic fibrosis in the breast, with sensitivity of at least 75% and specificity of 90%. Fibrosis is defined as grade ≥2 (CTCAE v 4.0) or skin induration as grade ≥2 defined according to CTCAE v 4.0 .
Secondary outcomes (23)
- measure
- Generation of a predictive model for acute skin toxicity
- timeFrame
- up to 2 years after start of treatment
- description
- Sensitivity of a model combining different variables to predict acute skin toxicity defined according to CTCAE scale v4.0 as dermatitis grade ≥2 or ulceration of the skin of grade ≥2
- measure
- Generation of a predictive model for late skin toxicity
- timeFrame
- up to 2 years after start of treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years; * Ability to express appropriate informed consent to treatment; * Distant nonmetastatic breast cancer; * Histology: infiltrating NST(no special type)/lobular carcinoma or ductal carcinoma in situ; * Stage: pTis; pT1-3 pN1-3 M0; * Hormone receptors, HER-2 status: Any; * Breast-conserving surgery. Both the sentinel lymph node biopsy and axillary lymphadenectomy. Negative surgical margins. * Candidates for postoperative radiation treatment. Exclusion Criteria: * Refusal of radiotherapy treatment (i.e., absence of signed informed consent); * Previous radiation therapy at the same site; * Concomitant chemotherapy with anthracyclines or taxanes; * Inability to maintain treatment position; * Partial breast radiotherapy (PBI); * Male breast cancer; * Mastectomy surgery.
References
Publications (0)
Data not yet available