TY - JOUR
T1 - The assisi think tank meeting breast large database for standardized data collection in breast cancer—attm.Blade
AU - Marazzi, Fabio
AU - Masiello, V.
AU - Masciocchi, Carlotta
AU - Merluzzi, M.
AU - Saldi, S.
AU - Belli, Paolo
AU - Boldrini, Luca
AU - Capocchiano, Nikola Dino
AU - Di Leone, Alba
AU - Magno, Stefano
AU - Meldolesi, Elisa
AU - Moschella, Francesca
AU - Mule, A.
AU - Smaniotto, Daniela
AU - Terribile, Daniela Andreina
AU - Tagliaferri, Luca
AU - Franceschini, Gianluca
AU - Gambacorta, Maria Antonietta
AU - Masetti, Riccardo
AU - Valentini, Vincenzo
AU - Poortmans, P. M. P.
AU - Aristei, Cynthia
PY - 2021
Y1 - 2021
N2 - Background: During the 2016 Assisi Think Tank Meeting (ATTM) on breast cancer, the panel of experts proposed developing a validated system, based on rapid learning health care (RLHC) principles, to standardize inter-center data collection and promote personalized treatments for breast cancer. Material and Methods: The seven-step Breast LArge DatabasE (BLADE) project included data collection, analysis, application, and evaluation on a data-sharing platform. The multidisciplinary team developed a consensus-based ontology of validated variables with over 80% agreement. This English-language ontology constituted a breast cancer library with seven knowledge domains: baseline, primary systemic therapy, surgery, adjuvant systemic therapies, radiation therapy, followup, and toxicity. The library was uploaded to the BLADE domain. The safety of data encryption and preservation was tested according to General Data Protection Regulation (GDPR) guidelines on data from 15 clinical charts. The system was validated on 64 patients who had undergone post-mastectomy radiation therapy. In October 2018, the BLADE system was approved by the Ethical Committee of Fondazione Policlinico Gemelli IRCCS, Rome, Italy (Protocol No. 0043996/18). Results: From June 2016 to July 2019, the multidisciplinary team completed the work plan. An ontology of 218 validated variables was uploaded to the BLADE domain. The GDPR safety test confirmed encryption and data preservation (on 5000 random cases). All validation benchmarks were met. Conclusion: BLADE is a support system for follow-up and assessment of breast cancer care. To successfully develop and validate it as the first standardized data collection system, multidisciplinary collaboration was crucial in selecting its ontology and knowledge domains. BLADE is suitable for multi-center uploading of retrospective and prospective clinical data, as it ensures anonymity and data privacy.
AB - Background: During the 2016 Assisi Think Tank Meeting (ATTM) on breast cancer, the panel of experts proposed developing a validated system, based on rapid learning health care (RLHC) principles, to standardize inter-center data collection and promote personalized treatments for breast cancer. Material and Methods: The seven-step Breast LArge DatabasE (BLADE) project included data collection, analysis, application, and evaluation on a data-sharing platform. The multidisciplinary team developed a consensus-based ontology of validated variables with over 80% agreement. This English-language ontology constituted a breast cancer library with seven knowledge domains: baseline, primary systemic therapy, surgery, adjuvant systemic therapies, radiation therapy, followup, and toxicity. The library was uploaded to the BLADE domain. The safety of data encryption and preservation was tested according to General Data Protection Regulation (GDPR) guidelines on data from 15 clinical charts. The system was validated on 64 patients who had undergone post-mastectomy radiation therapy. In October 2018, the BLADE system was approved by the Ethical Committee of Fondazione Policlinico Gemelli IRCCS, Rome, Italy (Protocol No. 0043996/18). Results: From June 2016 to July 2019, the multidisciplinary team completed the work plan. An ontology of 218 validated variables was uploaded to the BLADE domain. The GDPR safety test confirmed encryption and data preservation (on 5000 random cases). All validation benchmarks were met. Conclusion: BLADE is a support system for follow-up and assessment of breast cancer care. To successfully develop and validate it as the first standardized data collection system, multidisciplinary collaboration was crucial in selecting its ontology and knowledge domains. BLADE is suitable for multi-center uploading of retrospective and prospective clinical data, as it ensures anonymity and data privacy.
KW - Breast cancer
KW - Large database
KW - Networks
KW - Standardized data collection
KW - Breast cancer
KW - Large database
KW - Networks
KW - Standardized data collection
UR - http://hdl.handle.net/10807/178221
U2 - 10.3390/jpm11020143
DO - 10.3390/jpm11020143
M3 - Article
SN - 2075-4426
VL - 11
SP - 1
EP - 11
JO - Journal of Personalized Medicine
JF - Journal of Personalized Medicine
ER -