PERCEPTION Trial protocol: Comparison of predictive and prognostic capacities of neutrophil, lymphocyte, and platelet counts and tumor-infiltrating lymphocytes in triple negative breast cancer

Autor: Hugo Veyssière, Mathilde Gay-Bellile, Yannick Bidet, Catherine Abrial, Nathalie Lacrampe, Nina Radosevic-Robin, Myriam Kossai, Sejdi Lusho, Maureen Bernadach, Mathias Cavaillé, Ioana Molnar, Xavier Durando
Přispěvatelé: LUSHO, Sejdi, Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Division de Recherche Clinique, Délégation Recherche Clinique et Innovation, Centre de Lutte contre le Cancer, Centre Jean PERRIN, 58 rue Montalembert, 63011 Clermont-Ferrand Cedex1, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Centre d'investigation Clinique, UMR501, 63011 CLERMONT-FERRAND (CIC), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Département d'oncologie médicale, Centre Jean PERRIN, 63011 Clermont-Ferrand, Centre Jean Perrin, Département d'anatomie et de cytologie pathologiques., Centre Jean Perrin, Département d'oncogénétique
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Adult
Blood Platelets
Oncology
medicine.medical_specialty
Adolescent
Neutrophils
Lymphocyte
Breast Neoplasms
Triple Negative Breast Neoplasms
[SDV.CAN]Life Sciences [q-bio]/Cancer
Disease
Young Adult
03 medical and health sciences
Lymphocytes
Tumor-Infiltrating
0302 clinical medicine
Breast cancer
[SDV.CAN] Life Sciences [q-bio]/Cancer
Predictive Value of Tests
Internal medicine
Biomarkers
Tumor
medicine
Humans
Cytotoxic T cell
Lymphocyte Count
Lymphocytes
030212 general & internal medicine
Triple-negative breast cancer
ComputingMilieux_MISCELLANEOUS
Platelet Count
Tumor-infiltrating lymphocytes
business.industry
Cancer
General Medicine
Middle Aged
Prognosis
medicine.disease
3. Good health
Clinical trial
medicine.anatomical_structure
030220 oncology & carcinogenesis
Female
Neoplasm Recurrence
Local
business
Zdroj: Medicine (Baltimore)
Medicine (Baltimore), In press, 99 (50), pp.e23418. ⟨10.1097/MD.0000000000023418⟩
DOI: 10.1097/MD.0000000000023418⟩
Popis: Background Triple negative breast cancer affects 10% to 20% of all women diagnosed with breast cancer. Due to its characteristics, treatment strategies are limited and metastatic recurrences are common in the first 5 years after treatment. However, not all patients affected by this disease develop metastases. Tumor-infiltrating lymphocytes have shown to be reliable predictive biomarkers of treatment response and metastatic recurrences. However, we need to develop simpler and faster ways to predict response to cytotoxic treatment and the possibility of eventual cancer relapse by identifying new biomarkers. Recently, new studies are emerging, suggesting a predictive role of circulating blood cells in different types of cancer. In this study, we will assess the correlation between tumor-infiltrating lymphocytes and different elements of the blood count in patients diagnosed with triple negative breast cancer. Methods The main objective of this study is to evaluate the correlation between the peripheral neutrophil-to-lymphocyte ratio and the amount of tumor-infiltrating lymphocytes, assessed in triple negative breast cancer patients at diagnosis. Secondary objectives include evaluation of the correlation between tumor-infiltrating lymphocytes at diagnosis and the baseline absolute neutrophil, lymphocyte, and platelet counts, as well as the platelet-to-lymphocyte ratio. The triple negative breast cancer patients will be enrolled in the PERCEPTION trial during the first year after the treatment completion. Two supplementary blood tests, at 12 months after the end of treatment and at the time of the first metastatic recurrence, will be performed. Discussion The discovery of new prognostic and predictive biomarkers is crucial for triple negative breast cancer. We set up the PERCEPTION clinical trial in order to evaluate certain blood counts as early biomarkers and to assess their correlation with tumor-infiltrating lymphocytes. Demonstration of comparative predictive and/or prognostic capacities of peripheral blood counts and tumor-infiltrating lymphocytes would allow introduction of the former as simple and cheap biomarkers in triple negative breast cancer patient management. Trial registration The PERCEPTION study has been registered in the French National Agency of Medical Security registry on the 2nd of July 2019 under the number 2019-A01861-56 and in the ClinicalTrials.org registry under the number NCT04068623.
Databáze: OpenAIRE
Externí odkaz: