NCT04263948 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bouchahda M, Komarzynski S, Ulusakarya A, Attari A, Duprès A, Breda G, Fritsch A, Adam R, Lévi F (2020) Improving FOLFIRINOX safety in pancreatic cancer patients through multidimensional remote monitoring and proactive care using a domomedecine mobile platform
J Clin Oncol 38: TPS4673.
Innominato P, Komarzynski S, Karaboue A, Ulusakarya A, Bouchahda M, Haydar M, Bossevot-Desmaris R, Mocquery M, Plessis V, Levi F
Home-Based e-Health Platform for Multidimensional Telemonitoring of Symptoms, Body Weight, Sleep, and Circadian Activity: Relevance for Chronomodulated Administration of Irinotecan, Fluorouracil-Leucovorin, and Oxaliplatin at Home-Results From a Pilot Study. JCO Clin Cancer Inform. 2018 Dec;2:1-15. doi: 10.1200/CCI.17.00125.
Levi F, Komarzynski S, Huang Q, Young T, Ang Y, Fuller C, Bolborea M, Brettschneider J, Fursse J, Finkenstadt B, White DP, Innominato P
Tele-Monitoring of Cancer Patients' Rhythms during Daily Life Identifies Actionable Determinants of Circadian and Sleep Disruption. Cancers (Basel). 2020 Jul 17;12(7):1938. doi: 10.3390/cancers12071938.

Multidom Remote Monitoring of Patient With Advanced Pancreatic Cancer Treated With Florinox Using the PiCaDo Domomedecine Plateform

Clinical trial NCT04263948 - References