Sentinel Lymph NodeFLUOBREAST-2NCT05699291
Cost of Using FLUOrescence to Green of Indocyanine for the Detection of Breast Cancer.
An observational study of Sentinel Lymph Node, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sentinel Lymph Node
- What is being tested?
- Sentinel node detection technique
- How many people
- 163 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2023to 17 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patient with histologically proven breast cancer, eligible for sentinel lymph node technique by Indocyanine Green or isotopes
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Cost of Using FLUOrescence in Green of Indocyanine for the Detection of the Sentinel Lymph Node in the Breast Cancer.
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...
Read the detailed description
The main objective is 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 health insurance and the hospital.
The chosen time horizon is up to 1 month post-intervention. The choice of this time horizon corresponds to the usual duration of follow-up for patients who have benefited from one of the sentinel lymph node detection techniques, in order to collect the main post-surgical complications.
This is a multicenter, prospective, observational, non-randomized study, aimed at comparing the overall cost of two sentinel lymph node detection techniques (Indocyanine Green and isotope) from a dual perspective (health insurance and hospital).
- Conditions
- Sentinel Lymph Node
- Being tested
- Sentinel node detection technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel node detection techniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sentinel node detection technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start23 Feb 2023
- Primary completion17 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sentinel Lymph NodeStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699291
- Sponsor's protocol ID
- 2022-A02271-42
- Acronym
- FLUOBREAST-2
- Status last verified
- Jun 2024
- First submitted
- 16 Jan 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Cost of Using FLUOrescence in Green of Indocyanine for the Detection of the Sentinel Lymph Node in the Breast Cancer.
- ClinicalTrials.gov ID
- NCT05699291
- Acronym / sponsor ID
- FLUOBREAST-2 / 2022-A02271-42
- Conditions
- Sentinel Lymph Node
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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...
Detailed description
The main objective is 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 health insurance and the hospital.
The chosen time horizon is up to 1 month post-intervention. The choice of this time horizon corresponds to the usual duration of follow-up for patients who have benefited from one of the sentinel lymph node detection techniques, in order to collect the main post-surgical complications.
This is a multicenter, prospective, observational, non-randomized study, aimed at comparing the overall cost of two sentinel lymph node detection techniques (Indocyanine Green and isotope) from a dual perspective (health insurance and hospital).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient eligible for the sentinel lymph node technique by lndocyanine Green. | – | Other: Sentinel node detection techniqueTo 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. |
| Patient eligible for the sentinel lymph node technique by isotopes. | – | Other: Sentinel node detection techniqueTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with histologically proven breast cancer, eligible for sentinel lymph node technique by Indocyanine Green or isotopes
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel node detection techniquePatients cared for by a surgeon for histologically proven breast cancer and for whom an indication for detection of the sentinel lymph node is posed. | Other | Patient eligible for the sentinel lymph node technique by isotopes., Patient eligible for the sentinel lymph node technique by lndocyanine Green. |
Primary outcome
Average direct costs of the two techniques assessed (Indocyanine Green and isotopes)
Time frame: 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Sentinel Lymph Node
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sentinel Lymph Node, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average direct costs of the two techniques assessed (Indocyanine Green and isotopes) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.