Cost of Using FLUOrescence to Green of Indocyanine for the Detection of Breast Cancer.

NCT05699291 | Completed

• 1 other identifier: 2022-A02271-42
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to analyze the average direct costs of each of these techniques, represented by the costs directly linked to the management of breast cancer, to the surgical intervention and to the techniques evaluated (Indocyanine Green and isotopes) which are: consultations, hospitalizations, resources consumed during the surgical intervention, as well as the time of the patients, transport...

Conditions

Sentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

• Average direct costs of the two techniques assessed (Indocyanine Green and isotopes)

  To evaluate the overall cost at 1 month of the sentinel lymph node detection technique using Indocyanine Green compared to the technique using isotopes in patients with breast cancer, from the point of view of the health insurance and the hospital.

  1 month

Study Arms (2)

Patient eligible for the sentinel lymph node technique by lndocyanine Green.

To evaluate the overall cost at 1 month of the sentinel lymph node detection technique using Indocyanine Green in patients with breast cancer, from the point of view of the health insurance and the hospital.

Other: Sentinel node detection technique

Patient eligible for the sentinel lymph node technique by isotopes.

To evaluate the overall cost at 1 month of the sentinel lymph node detection technique using isotopes in patients with breast cancer, from the point of view of health insurance and the hospital.

Other: Sentinel node detection technique

Interventions

Sentinel node detection technique OTHER

Patients cared for by a surgeon for histologically proven breast cancer and for whom an indication for detection of the sentinel lymph node is posed.

Patient eligible for the sentinel lymph node technique by isotopes.; Patient eligible for the sentinel lymph node technique by lndocyanine Green.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patient with histologically proven breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with histologically proven breast cancer, eligible for sentinel lymph node technique by Indocyanine Green or isotopes

You may qualify if:

• Patient aged 18 or over, having given her oral non-objection ;
• Patient with histologically proven breast cancer ;
• Patient eligible for the sentinel lymph node technique by Indocyanine Green or isotopes.

You may not qualify if:

• Patient who has expressed her opposition to the use of her medical data ;
• Patient under legal protection, guardianship or curatorship ;
• Pregnant patient ;
• Patient not affiliated to a social security scheme.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital privé des Peupliers

Paris, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: February 23, 2023
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)