Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2026-03-05 @ 9:29 PM
Study NCT ID:
NCT06505018
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2024-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemonitoring Platform "CUREETY TECHCARE" vs Standard of Care for mTBNC Patients Initiating a First-line Treatment
Sponsor:
UNICANCER
Organization:
Study Overview
Official Title:
A Randomized Phase III Study Comparing the Digital Telemonitoring Platform "CUREETY TECHCARE" to Usual Standard of Care in Patients With Triple Negative Metastatic Breast Cancer Initiating a First-line Systemic Treatment
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALTERNATIVE
Brief Summary:
The goal of this clinical trial is to assess whether adding telemonitoring (the digital telemonitoring platform "CUREETY TECHCARE"), to standard care, will benefit patients with previously untreated metastatic triple-negative breast cancer starting first-line cancer therapy.
The main questions it aims to answer are:
* Is patient quality of life improved by using the telemonitoring platform?
* Are patients hospitalized less frequently when using the telemonitoring platform?
* Is the patient overall survival improved by telemonitoring ?
Researchers will compare data from patients using telemonitoring while receiving standard care with data from patients receiving only standard care.
Participants using telemonitoring will answer questions about their symptoms on the platform. The platform will analyze these symptoms, assess the patient's general condition and provide advice accordingly. Medical staff will also access the platform to monitor the patient's general condition and contact them if necessary.
The main questions it aims to answer are:
* Is patient quality of life improved by using the telemonitoring platform?
* Are patients hospitalized less frequently when using the telemonitoring platform?
* Is the patient overall survival improved by telemonitoring ?
Researchers will compare data from patients using telemonitoring while receiving standard care with data from patients receiving only standard care.
Participants using telemonitoring will answer questions about their symptoms on the platform. The platform will analyze these symptoms, assess the patient's general condition and provide advice accordingly. Medical staff will also access the platform to monitor the patient's general condition and contact them if necessary.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IDRCB NUMBER: 2023-A02477-38 | OTHER | CPP Sud-Méditerranée III | View |