Study of Cancer Patients' Preferences for Genetic Information Modalities Preceding Theranostic Exome Analysis. Qualitative Observational and Interventional Cross-sectional Study

Currently, the EXOMA2 study (NCT04614480) offers earlier and more comprehensive exome analysis in the management of cancer patients than EXOMA. Based on the active EXOMA2 patient file, the INFOGene study offers the opportunity to study patient-physician communication, to assess patient preferences with regard to different information modalities concerning theranostic exome analysis, and to reflect on information modalities to ensure optimal patient comprehension of the information provided.
The qualitative cross-sectional study includes a dual observational and interventional component involving cancer patients. The patients will come from the EXOMA 2 active file at Dijon University Hospital and the CGFL.

开始日期2024-09-01

申办/合作机构

Centre Georges François Leclerc

NCT05695313 / Recruiting临床2期IIT

Phase II Multicentric, Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL

This study recommends the use of OnLife dietary supplement, which will be followed by a few day before the initiation of PACLITAXEL, for the prevention of PACLITAXEL induced neuropathy. OnLife will be continued one month after stopping chemotherapy.
This would limit the number of PACLITAXEL dose reductions and premature interruptions of this chemotherapy, thus potentially improving the results in terms of antitumor efficacy, while improving the quality of life of patients treated with weekly PACLITAXEL.

开始日期2024-04-12

申办/合作机构

Centre Georges François Leclerc

NCT05937906 / Not yet recruiting临床1/2期IIT

Phase Ib/II Clinical Trial Evaluating the Safety and Efficacy of Chemoimmunotherapy Plus Short Course of Mek Inhibitor in First Line of Treatment of Metastatic Non Squamous Non Small Cell Lung Adenocarcinoma With PDL1 < 50 %.

Monocentric study composed by 2 steps :
First step is a phase I with the aim of establish the recommended dose of mirdametinib administration (2 or 4 mg twice a day for 7 or 14 days per cycle for the 4 first of carboplatin/pemetrexed/pembrolizumab treatment)
Second step is a non comparative randomized (2:1) phase II trial testing the recommended dose of mirdametinib administration. The aim is the efficacy and safety of short course of mirdametinib treatment for the 4 first cycles of the carboplatin/pemetrexed/pembrolizumab treatment.

开始日期2024-04-01

申办/合作机构

Centre Georges François Leclerc

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项与 Centre Georges François Leclerc 相关的文献（医药）

2025-01-01·Patient Education and Counseling

Health literacy and the use of digital tools in older patients with cancer and their younger counterparts: A multicenter, nationwide study

Article

作者: Gay, Pierre ; Culine, Stéphane ; Solem-Laviec, Heidi ; Mathoulin-Pélissier, Simone ; Hue, Lucas ; Boudou-Rouquette, Pascaline ; Annonay, Mylène ; Saint-Lezer, Arnaud ; Grellety, Thomas ; Teyssonneau, Diego ; Paillaud, Elena ; Ayati, Siavoshe ; Pulido, Marina ; Tchalla, Achille ; Boulahssass, Rabia ; Galvin, Angéline ; Poisson, Johanne ; Doublet, Solène ; Baldini, Capucine ; Lalet, Caroline ; Perrin, Christophe

OBJECTIVESTo evaluate health literacy (HL), assess the use of digital tools/sources, and identify factors associated with low or moderate HL in older (aged ≥65) and younger (18-64) patients with cancer.METHODSA cross-sectional multicenter study including patients with cancer was conducted in 26 centers in France. HL was assessed using the Functional, Communicative and Critical Health Literacy (FCCHL) scale. Factors associated with low/moderate HL (scoreRESULTSThe population comprised 669 patients aged 18-64 and 658 patients aged 65 + . The older patients used digital tools less than younger patients did. The median overall HL score was: 3.7 and 3.6, for younger and older patients respectively. The need for help to fill out the questionnaire was associated with low/moderate HL in both age groups. Then, older age and living in rural area were associated with low/moderate HL in younger patients only, and rare internet use in older patients.CONCLUSIONThis article highlights the importance of considering HL in care management, as well as whom patients may present higher risk of low HL.PRACTICE IMPLICATIONSIt is crucial to assess HL in patients with cancer, and then to seize every opportunity to enhance HL.

2024-12-31·OncoImmunology

CD3-CD8 immune score associated with a clinical score stratifies PDAC prognosis regardless of adjuvant or neoadjuvant chemotherapy

Article

作者: Bibeau, Frederic ; Vienot, Angélique ; Monnien, Franck ; Borg, Christophe ; Huppe, Titouan ; Rageot, David ; Truntzer, Caroline ; Ghiringhelli, François ; Ilie, Alis ; Derangère, Valentin ; Schoumacher, Coralie ; Gaudillière-Le Dain, Gwladys

Stratification of the prognosis of pancreatic cancer (PDAC) patients treated by surgery is based solely on clinical variables, such as tumor stage and node status. The development of biomarkers of relapse is needed, especially to drive administration of adjuvant therapy in this at-risk population. Our study evaluates the prognostic performance of a CD3- and CD8-based immune score. CD3, CD8 and Foxp3 expression were evaluated on whole slides in two retrospective PDAC cohorts totaling 334 patients. For this study, we developed an immune score to estimate CD3 and CD8 infiltration in both tumor core and invasive margin using computer-guided analysis with QuPath software. Variables were combined in a dichotomous immune score. The association between immune and clinical scores, and both PFS and OS was investigated. We observed that a dichotomous immune score predicts both PFS and OS of localized PDAC. By univariate and multivariate analysis, immune score, tumor grade, adjuvant therapy, lymph node status, and adjuvant chemotherapy administration were associated with PFS and OS. We subsequently associated the PDAC immune score and clinical variables in a combined score. This combined score predicted patient outcomes independently of adjuvant or neoadjuvant treatment, and improved patient prognostic prediction compared to clinical variables or immune score alone.

2024-12-01·The Breast

Real-world prevalence, treatment and survival of “high risk” early breast cancer, with mandatory testing of gBRCA1/2 mutation according to the OlympiA trial inclusion criteria: Data from a population-based registry

Article

作者: Kaderbhai, Courèche ; Reda, Manon ; Albuisson, Juliette ; Ilie, Silvia Mihaelia ; Dabakuyo, Sandrine ; Arnould, Laurent ; Mamguem Kamga, Ariane ; Truntzer, Caroline ; Nambot, Sophie ; Ilie, Silvia ; Desmoulins, Isabelle ; Galland, Loick ; Mayeur, Didier ; Hennequin, Audrey ; Coutant, Charles ; Jankowski, Clementine ; Ladoire, Sylvain

BACKGROUNDThe results of the OlympiA study led to the approval of a PARP inhibitor (olaparib) as adjuvant treatment for early breast cancer (eBC) at high risk of relapse in patients with a germline BRCA1/2 mutation (gBRCAm). However, the proportion of patients in routine practice who meet the "high-risk" criteria applied in the OlympiA study, and for whom gBRCAm testing would now be mandatory, remains unknown.PATIENTS AND METHODSIn this population-based study, we use unique data from the French specialized Côte d'Or Breast and Gynecological Cancer Registry, to assess the real-life proportion, and long-term prognosis of patients treated for eBC between 2005 and 2015 with standard treatment, and at "high risk" of relapse according to the OlympiA trial criteria.RESULTSWe included 3483 patients treated for HER2-negative eBC (N = 380 with ER-, and N = 3103 with ER + tumor). We found N = 62 (1.8 %) patients with gBRCA1/2 mutations. A total of 494 patients (14.2 %) were classified as "high risk" according to the Olympia criteria; 55 % with ER-tumors, and 9.1 % with ER + tumors, respectively. Despite more intensive systemic treatments in "high risk" patients, 10-year overall survival was much worse in these "high risk" patients compared to the others: 60.1 % vs 83.8 % in ER-tumors, and 55.4 % vs 84.1 % in ER + tumors. Our estimates of net survival show an even greater difference.CONCLUSIONThis study provides real-life insights into the prevalence and prognosis of patients with high-risk eBC, in a context where the approval of adjuvant olaparib requires careful reorganization of care, so as not to overlook a patient with gBRCAm who could benefit from adjuvant olaparib.

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