- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05107388
Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer (AAREN)
October 25, 2021 updated by: Centre Hospitalier Universitaire de Besancon
AAREN: Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer
The purpose of this study is to describe the glycemic profile of postmenopausal women treated with alpelisib plus fulvestrant using a continuous blood sugar monitoring device (FreeStyle Libre Pro) over 14 days
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
AAREN is a monocentric prospective study monitoring glycemic profile in patients treated with alpelisib plus fulvestrant.
Patients will wear a noninvasive glucose monitoring sensor, the Freestyle Libre Pro for a 14 day period.
Forty patients will be enrolled.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fatimata SARR SALL, PhD
- Phone Number: 033381219449
- Email: fatimata.sarr@chu-besancon.fr
Study Locations
-
-
-
Besançon, France, 25000
- CHu de Besançon
-
Contact:
- Fatimata SARR SALL, PhD
- Email: fatimata.sarr@chu-besancon.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women suffering breast cancer and eligible to treatment with Alpelisib
- Age ≥18 years
- Menopausal women (for at least 24 months)
- Informed Consent Form signed
Exclusion Criteria:
- Men
- Pregnant ou child-bearing potential women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Continuous interstitial glucose measurements
Variations of interstitial glucose are measured during 14 days with FreeStyle Libre Pro
|
Measurements of interstitial glucose variations with FreeStyle Libre Pro
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence rate of hyperglycemia
Time Frame: Day 14
|
In percentage, measured before breakfast and diner (fasting blood glucose). Hyperglycemia defined as follows:
|
Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sophie BOROT, MD, PhD, CHu de Besançon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2021
Primary Completion (Anticipated)
January 1, 2024
Study Completion (Anticipated)
March 1, 2024
Study Registration Dates
First Submitted
October 25, 2021
First Submitted That Met QC Criteria
October 25, 2021
First Posted (Actual)
November 4, 2021
Study Record Updates
Last Update Posted (Actual)
November 4, 2021
Last Update Submitted That Met QC Criteria
October 25, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/609
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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