An observational study in Breast Cancer, sponsored by Instituto de Investigacion Sanitaria La Fe. Recruiting at 8 sites in 8 countries. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-02-03.
Sponsored by Instituto de Investigacion Sanitaria La Fe · Observational
RadioVal will develop and implement interoperable solutions for clinical deployment of the radiomics tools, including information, training, and communication packages for clinicians and patients, as well as standard operating procedures for the integration of radiomics in clinical oncology. With this study, we will clinically validate these solutions, by looking at their reliability for precise breast cancer diagnosis, treatment recommendation and prognosis estimate, treatment response, evaluation of residual disease and outcome prediction.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Instituto de Investigacion Sanitaria La Fe is the lead sponsor of 57 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated with chemotherapy prior to surgery
Exclusion Criteria:
those patients with no response or partial response when administered with Chemotherapy prior to sugery
Other: The development of new clinical AI solutions to predict treatment response to neoadjuvant chemotherapy (NAC) in breast cancer
Evaluate response to neoadjuvant treatment in advanced breast cancer
Percentage of patients non-respondents vs respondents in neoadjuvant breast cancer treatment (Estimate tumor aggressiveness)
Proportion of patients who have complete response evaluating the target lesion according to Miller/Payne Grading system \[Ogston et al., 2003\]: 1A. Evaluation of target Tumor: G5 as pathological complete response, no tumor left; G4:more than 90% loss of tumor cells; G3: between 30-90% reduction in tumor cells; G2: loss of tumor \<30%; G1: no reduction. 1B: Evaluating the lymph nodes: A: negative; B: lymph nodes with metastasis and without changes by chemotherapy; C: lymph nodes with metastasis with evidence of partial response, D: lymph nodes with changes attributed to response without residual infiltration. 1C: Using images to evaluated radiological response: Size and diameter in millimeters of the target lesion using RM and TC or PET/CT for extension analysis (lymph nodes and metastasis).
Time frame: Baseline and after neoadjuvant treatment (4-6 months)
Plan to share: No — N/D
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Instituto de Investigacion Sanitaria La Fe