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Trial Title:
A Study to Develop Molecular Integrated Predictive Models of Breast Radio-toxicity (Precise-RTox)
NCT ID:
NCT06114589
Condition:
Breast Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
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.
Detailed description:
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. Currently there are numerous predictive models of toxicity
(Normal Tissue Complication Probability, NTCP) which are based on dosimetric and
sometimes also clinical data. To date, they do not include individual genetic
variability. However, it is believed that inter-individual variability may be responsible
for up to 40% of actinic toxicity. Multiparametric models that consider genetics, dose
and clinical aspects probably better reflect the complexity of radiotoxicity than models
that rely on a single parameter and it is possible to integrate such parameters using a
machine learning approach. The definition of the molecular and genetic variables related
to radiotoxicity and their integration into predictive molecular signatures would
therefore allow the risk 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.
Criteria for eligibility:
Study pop:
Women with distant non-metastatic breast cancer candidated to radiotherapy after
conservative surgery
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Centro di Riferimento Oncologico (CRO) di Aviano - IRCCS
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Lorenzo Vinante, MD
Phone:
+390434659855
Email:
lorenzo.vinante@cro.it
Investigator:
Last name:
Lorenzo Vinante, MD
Email:
Principal Investigator
Investigator:
Last name:
Barbara Belletti, PhD
Email:
Principal Investigator
Start date:
August 25, 2022
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Centro di Riferimento Oncologico - Aviano
Agency class:
Other
Source:
Centro di Riferimento Oncologico - Aviano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06114589
