A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
NCT06406465
Adenocarcinoma, Carcinoma
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT06043193
The study consists of having participants complete quality of life questionnaires (PROMs) at the time of the cures +/- one week and in the middle of the intercure time +/- one week.
As all the collection times do not correspond to a consultation or a visit to a medical service, The investigator wanted to develop a remote, computerized data collection solution.
Researchers have programmed an AURA-RIV-TNE care pathway (MOCAs: Engine for the organization and coordination of health acts) on the myHCL patient environment, taking up the course of the study presented in the form of a table in paragraph 6.2. Once the patient consents to participate in the study, he must create an account on the patient interface of his investigation center (myHCL, myCHUGA etc) as much as possible to facilitate data extraction.
Once the patient consents to participate in the study, the MOCAs AURA-RIV-TNE course will be associated with him in the Easily software, by defining the date week 0 (baseline) of the first treatment. This will allow automated sending of MAIL and SMS reminders at each questionnaire time. The MAILs will contain an internet link allowing the participant to be directly written to the questionnaires to be completed. A reminder system will be possible if the patient does not complete the questionnaire.
Interested in participating?
Request Info18 year and older
All sexes
Observational
CHU de Saint-Etienne, Hôpital Nord, Saint-Priest-en-Jarez, Saint-Etienne, France
The study consists of having participants complete quality of life questionnaires (PROMs) at the time of the cures +/- one week and in the middle of the intercure time +/- one week.
As all the collection times do not correspond to a consultation or a visit to a medical service, the investigator wanted to develop a remote, computerized data collection solution.
The investigator programmed an AURA-RIV-TNE care pathway (MOCAs: Engine for the organization and coordination of health acts) on the myHCL patient environment, taking up the course of the study presented in the form of a table in paragraph 6.2. Once the patient consents to participate in the study, he must create an account on the patient interface of his investigation center (myHCL, myCHUGA etc) as much as possible to facilitate data extraction.
Once the patient consents to participate in the study, the MOCAs AURA-RIV-TNE course will be associated with him in the Easily software, by defining the date week 0 (baseline) of the first treatment. This will allow automated sending of MAIL and SMS reminders at each questionnaire time. The MAILs will contain an internet link allowing the participant to be directly written to the questionnaires to be completed. A reminder system will be possible if the patient does not complete the questionnaire.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Collection time: Week 0 (baseline) and 1 year
The main quality of life criterion would be changed by the score of the EORTC-QLQC30 scale. 10% missing data tolerable
Time frame: Collection time: Week 0 (baseline)
Analysis of quality of life at baseline (Week 0) according to patient demographic profile and the characteristics of the tumour.
Time frame: Time of collection: Week 0 (baseline), 6 months and 1 year
.Analysis of the primary endpoint according to the Health Related Quality of Life (HRQoL) between inclusion (before the first cycle-IVR1), during IVR (IVR2 to IVRn), at 6 and 12 months after IVR1, will be assessed by 4 questionnaires (EORTC QLQ-C30 + EORTC QLQ-GI.NET21 + EQ-5D + HADS) forming a composite criterion.and response to treatment.
Contact information is provided by the study sponsor or research team.
Adeline MANSUY
CONTACT
4 72 11 51 70 ext. +33
Nicolas JACQUET-FRANCILLON, MD
CONTACT
4 72 35 69 99 ext. +33
Hospices Civils de Lyon
Other
Acronym: AURA-RIV-TNE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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