Breast CancerSAGENCT02056886
Medico-economic Study of Three Strategies of Sentinel Lymph Node Analysis in Operable Breast Cancer
A study testing SLN detection +/- complementary axillary lymphadenectomy in people with Breast Cancer and Surgery, run by Institut Cancerologie de l'Ouest at 17 sites in France.
Trial summary
Breast carcinoma requires frequently an adjuvant therapy after surgical excision: in this way, one of the major criteria indicating the need of adjuvant chemotherapy is the diagnosis of a metastatic lymph-node invasion, mainly in the axillary field. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Surgery
- What is being tested?
- SLN detection +/- complementary axillary lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 858 participants
- Where
- 17 sitesFrance
- Study dates
- 21 Oct 2013to 15 Feb 2022
- Phase
- Interventional
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Infiltrating breast carcinoma histologically proven (lobular, ...)
- unifocal,
- T <3 cm (clinical), palpable or non-palpable tumor (smaller than a centimetre allowed),
- N0 clinical axillary
- Conservative surgery,
- GS detection by isotopic or combined method,
Show all 9Show fewer
- Age <65 (for more frequent activity), and> 18 years.
- Social protection
- Signed Informed consent
Who cannot join
- Recurrence of breast carcinoma,
- History of ipsilateral breast reduction surgery,
- Radical surgery.
- History of lumpectomy
- Neoadjuvant chemotherapy
- Multi-focality
Show all 10Show fewer
- Neoadjuvant hormone therapy
- < 18 years old
- Pregnant or nursing patient or of childbearing age without effective contraception,
- Legal incapacity or limited legal capacity. Medical or psychological conditions not allowing the subject to understand the study and sign the consent.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
ICO Paul Papin
Angers, 49000
Institut Bergonie
Bordeaux, 33000
Jean Perrin
Clermont-Ferrand, 63011
Institut du Sein -Clinique Saint-Amé
Lambres-lez-Douai, 59552
Oscar Lambret
Lille
Institut Paoli Calmettes
Marseille, 13009
HEGP
Paris, 75015
Institut Curie
Paris, 75248
CHU
Pierre-Bénite, 69495
Eugène Marquis
Rennes
Henri BECQUEREL
Rouen, 76038
Institut Curie
Saint-Cloud, 92210
Clinique Mutualiste
Saint-Etienne, 42013
Jean-Marc cancérologie CLASSE
Saint-Herblain, 44800
CHU
Saint-Priest-en-Jarez, 42277
IUCT-O
Toulouse, 31052
Institut de Cancérlogie de Lorraine
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Multicentric, National, Prospective, Comparative, Non Randomized Study, Assessing Medico-economic Impact of Three Strategies of Sentinel Lymph Node Analysis in Immediately Operable Breast Cancer
Breast carcinoma requires frequently an adjuvant therapy after surgical excision: in this way, one of the major criteria indicating the need of adjuvant chemotherapy is the diagnosis of a metastatic lymph-node invasion, mainly in the axillary field. Axillary surgery is therefore mandatory at the diagnosis of breast carcinoma. For many years, in order to avoid unnecessary complications due to extensive axillary surgery (for instance, arm enlargement by lymphedema), a limited surgery is frequently performed on the first supposed invaded lymph-nodes (LN) called "sentinel" LN technique; if the sentinel LN are not invaded, extensive axillary surgery can be omitted. To decide it during the surgery, removed sentinel LN are cut in 3 to 4 slices which are examined immediately as smears (cytology) or frozen slices (pathology). However, due to hazard in cutting the LN, micro-metastases can be misdiagnosed. That is why a recent molecular biology method has been developed in which the total LN are crushed and blended, then analyzed by OSNA technique (One Step Nuclear Acid analysis) so as to amplify and detect the mRNA coding for cytokeratin-19 protein witnessing the LN metastatic invasion. A standardized automated technique is available with a mean time of 30 to 50 minutes according to the number of analyzed LN.
In 12 international studies (2830 cases) the consistency between OSNA technique and final pathology is of 91 to 98% and the sensitivity seems higher. Less than 5% of all breast carcinomas cells don't express CK-19 protein.
Read more
The use of OSNA technique requires a dedicated machine and a skilled pathologist, increasing slightly the operation time; however it allows to avoid the immediate and long-term complications due to the radical LN axillary surgery in case of negativity of the sentinel LN procedure. To date, the three techniques including extemporaneous examinations (OSNA or classical methods) or not (classical pathological analysis) have their own advantages and drawbacks.
"SAGE" study main objective is to compare these three techniques in terms of direct costs and Quality of Life impacts. The superiority of any of these three techniques is not the purpose of SAGE study, but the economic burden of OSNA technique in comparison with the 2 others in the standard setting in France.
Quality of Life and Pain evaluations will be performed immediately after surgery and during the 6 months after.
Read the detailed description
Today, standard treatment for early Breast carcinoma starts with a surgical step consisting of the tumor resection and sentinel lymph-node (SLN) detection, in order to select patients to be proposed for complementary axillary lymphadenectomy. This requested information may be obtained during the same operation time by intra operative examination, or after surgery with the consequence of a second surgical procedure when lymphadenectomy appears to be indicated. In France, three strategies are currently used for the management of sentinel lymph nodes:
- intra operative pathological frozen section examination followed by final pathological diagnosis,
- intra operative molecular biology using the OSNA technique (One Step Nuclear Acid analysis)
- no intra operative examination, but the final pathological examination. Each of these 3 strategies has advantage and drawbacks and their own cost. With more than 50000 new cases per year in France, Breast carcinoma, thanks to population screening, more and more small tumors are detected where such information about sentinel LN invasion is needed.
Our proposed study is a prospective, cost-effectiveness and comparative non randomised study where three strategies are evaluated in the current practice of the participating teams.
Main Objective :
- to evaluate in each of these 3 strategies for sentinel LN diagnosis, cost-effectiveness and cost-utility (QALY), Quality of Life,…
Secondary Objectives :
- rate of second surgery needed
- rate of mico-metastases or macro-metastases detected to build a decision score,
- follow-up of non re-operated patient despite positive sentinel LN,
- RNA collection from the crushed and blended sentinel LN
- Quality of Life evaluation through the surgical times using QLQ C30 and Br 23 scales.
Medical section :
At pre-operative consultation, patients will be informed to consent participating in our observational study, without any change in their treatment strategy. Inclusion parameters are strictly the same in the three groups.
At the time of surgery, if intra operative examination is planned, patient will be informed that a complete axillary dissection could be indicated.
Included patients will be followed 15 days after surgery and at 3 and 9 months. Then every 6 months during 2 years, then yearly.
Economical section :
Main objective of " SAGE " study is to light up decision maker in striking the balance of each strategy (induced costs and prevented costs) and results in terms of health as expressed by individuals preference depending on different health status, treatment strategies and clinical practice in French centers.
In our study, the medico-economical evaluation on such a quite National scale (17 different centers) takes place in a practice standardization prospect.
General methodology :
In each participating center, one of the 3 strategies for the sentinel LN analysis is currently used (with or without extemporaneous procedure).
Cost-effect evaluation will inventory all undertaken costs in each strategy and all induced positive or negative consequences, both at a qualitative and quantitative level using micro costing and macro costing evaluations. Evaluation of Quality of Life adjusted to health will be included to the cost effect analysis.
In our study, population studied with a localized breast carcinoma, are women aged between 18 and 65 years old and likely to be active : inclusion criteria are strictly the same in the 3 strategies studied.
In our study, we will consider Hospital and Health Insurance point of view. Hospital prospect will identify and value the cost paid by health institution due to the use of any of these 3 techniques.
Insurance Health prospect will value the costs of each treatment strategy including direct costs related to private medical care and not only those to be reimbursed to the hospital.
The study starts at the time of the sentinel LN excision and ends 9 months later, including the post-operative complications and the possible second surgery for axillary LN excision.
At all 920 patients will be included in the 20 participating team.
- Conditions
- Breast Cancer, Surgery
- Being tested
- SLN detection +/- complementary axillary lymphadenectomy
- Keywords
- breast cancer, sentinel lymph node, extemporaneous, OSNA
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLN detection +/- complementary axillary lymphadenectomyProcedure or surgery
Also called Surgical complementary dissection of axillary lymph-node.
breast cancer surgery with SLN detection +/- complementary axillary lymphadenectomy Whatever the detection method used in the lab (Arm A: OSNA; Arm B: Pathological Examination; Arm C: Extemporaneous) to assess the positivity of sentinel lymph-node invasion, if negative result (no tumor invasion in the sentinel LN), a complementary lymph-node dissection is not mandatory if positive result (tumor invasion in the sentinel LN), a complementary lymph-node dissection is performed, either immediately (Arm A and C) or in a second surgical procedure (Arm B)
| Study group | Role | What they receive |
|---|---|---|
| OSNA | Experimental | Intra operative sentinel lymph-node sampling. In this experimental arm, the molecular biology technique is only used through the OSNA technique (One Step Nuclear Acid analysis), and no other classical pathology's diagnosis method such as formalin fixation, then parraffin embedding before slices cutting, hematoxylin-eosin-safran staining or any other immunohistochemical stainings.
According to the results of the staging procedure, the treatment in this arm is decided in conformity with local and national guidelines in breast cancer treatments.
SLN detection +/- complementary axillary lymphadenectomy is immediately decided if a tumor invasion is detected within the sentinel LN material. Receives: Procedure: SLN detection +/- complementary axillary lymphadenectomy |
| PATHOLOGICAL ANALYSIS | Other | No intra operative examination is performed in this arm, but the final pathological examination:
In this arm, the classical pathology's diagnosis method is starting with a formalin fixation of suspected invaded lymph-nodes sampling at least 24Hrs; then parraffin embedding before slices cutting; then hematoxylin-eosin-safran staining or any other immunohistochemical stainings.
According to the results of the staging procedure, the treatment in this arm is decided in conformity with local and national updated guidelines in breast cancer treatments.
SLN detection +/- complementary axillary lymphadenectomy: is decided in a second surgical step when the pathologic analysis has detected a tumor invasion Receives: Procedure: SLN detection +/- complementary axillary lymphadenectomy |
| EXTEMPORANEOUS | Other | "Intra-operative" pathological frozen sections of sentinel LN samples are coloured and examined immediately by the pathologist, allowing an immediate result at the disposal of the surgeon who can decide to complete by an axillary LN dissection or not.
Then the remaining material will be prepared similarly as in the pathological classical method (Arm B), ie formalin fixation, then parraffin embedding, then slices cutting, then HES staining or ImmunoHistochemistry for a final diagnosis.
SLN detection +/- complementary axillary lymphadenectomy: is decided immediately when the tumor invasion is detected in the sentinel LN material. Receives: Procedure: SLN detection +/- complementary axillary lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medico-economic study : medical cost between 3 different sentinel lymph node analysis (histological analysis or molecular biology) in the management of patients treated for invasive breast carcinoma.
Several phases are differences to compare the costs of three strategies:
- surgery
- hospitalization
- follow-up
Measured: from surgery to 9 mounths later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study start21 Oct 2013
- Primary completion2 Jan 2018
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 858 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie BORDES, MD, Study director, Institut de Cancérologie de l'Ouest (ICO) - Nantes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056886
- Sponsor's protocol ID
- ICO-N-2012-08
- Other IDs
- 2012-A01504-39
- Acronym
- SAGE
- Status last verified
- Apr 2022
- First submitted
- 5 Feb 2014
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric, National, Prospective, Comparative, Non Randomized Study, Assessing Medico-economic Impact of Three Strategies of Sentinel Lymph Node Analysis in Immediately Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT02056886
- Acronym / sponsor ID
- SAGE / ICO-N-2012-08
- Conditions
- Breast Cancer, Surgery
- Keywords
- breast cancer, sentinel lymph node, extemporaneous, OSNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 858 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 21 Oct 2013 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 6 Feb 2014 (estimated)
- 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.
Breast carcinoma requires frequently an adjuvant therapy after surgical excision: in this way, one of the major criteria indicating the need of adjuvant chemotherapy is the diagnosis of a metastatic lymph-node invasion, mainly in the axillary field. Axillary surgery is therefore mandatory at the diagnosis of breast carcinoma. For many years, in order to avoid unnecessary complications due to extensive axillary surgery (for instance, arm enlargement by lymphedema), a limited surgery is frequently performed on the first supposed invaded lymph-nodes (LN) called "sentinel" LN technique; if the sentinel LN are not invaded, extensive axillary surgery can be omitted. To decide it during the surgery, removed sentinel LN are cut in 3 to 4 slices which are examined immediately as smears (cytology) or frozen slices (pathology). However, due to hazard in cutting the LN, micro-metastases can be misdiagnosed. That is why a recent molecular biology method has been developed in which the total LN are crushed and blended, then analyzed by OSNA technique (One Step Nuclear Acid analysis) so as to amplify and detect the mRNA coding for cytokeratin-19 protein witnessing the LN metastatic invasion. A standardized automated technique is available with a mean time of 30 to 50 minutes according to the number of analyzed LN.
In 12 international studies (2830 cases) the consistency between OSNA technique and final pathology is of 91 to 98% and the sensitivity seems higher. Less than 5% of all breast carcinomas cells don't express CK-19 protein.
The use of OSNA technique requires a dedicated machine and a skilled pathologist, increasing slightly the operation time; however it allows to avoid the immediate and long-term complications due to the radical LN axillary surgery in case of negativity of the sentinel LN procedure. To date, the three techniques including extemporaneous examinations (OSNA or classical methods) or not (classical pathological analysis) have their own advantages and drawbacks.
"SAGE" study main objective is to compare these three techniques in terms of direct costs and Quality of Life impacts. The superiority of any of these three techniques is not the purpose of SAGE study, but the economic burden of OSNA technique in comparison with the 2 others in the standard setting in France.
Quality of Life and Pain evaluations will be performed immediately after surgery and during the 6 months after.
Detailed description
Today, standard treatment for early Breast carcinoma starts with a surgical step consisting of the tumor resection and sentinel lymph-node (SLN) detection, in order to select patients to be proposed for complementary axillary lymphadenectomy. This requested information may be obtained during the same operation time by intra operative examination, or after surgery with the consequence of a second surgical procedure when lymphadenectomy appears to be indicated. In France, three strategies are currently used for the management of sentinel lymph nodes:
- intra operative pathological frozen section examination followed by final pathological diagnosis,
- intra operative molecular biology using the OSNA technique (One Step Nuclear Acid analysis)
- no intra operative examination, but the final pathological examination. Each of these 3 strategies has advantage and drawbacks and their own cost. With more than 50000 new cases per year in France, Breast carcinoma, thanks to population screening, more and more small tumors are detected where such information about sentinel LN invasion is needed.
Our proposed study is a prospective, cost-effectiveness and comparative non randomised study where three strategies are evaluated in the current practice of the participating teams.
Main Objective :
- to evaluate in each of these 3 strategies for sentinel LN diagnosis, cost-effectiveness and cost-utility (QALY), Quality of Life,…
Secondary Objectives :
- rate of second surgery needed
- rate of mico-metastases or macro-metastases detected to build a decision score,
- follow-up of non re-operated patient despite positive sentinel LN,
- RNA collection from the crushed and blended sentinel LN
- Quality of Life evaluation through the surgical times using QLQ C30 and Br 23 scales.
Medical section :
At pre-operative consultation, patients will be informed to consent participating in our observational study, without any change in their treatment strategy. Inclusion parameters are strictly the same in the three groups.
At the time of surgery, if intra operative examination is planned, patient will be informed that a complete axillary dissection could be indicated.
Included patients will be followed 15 days after surgery and at 3 and 9 months. Then every 6 months during 2 years, then yearly.
Economical section :
Main objective of " SAGE " study is to light up decision maker in striking the balance of each strategy (induced costs and prevented costs) and results in terms of health as expressed by individuals preference depending on different health status, treatment strategies and clinical practice in French centers.
In our study, the medico-economical evaluation on such a quite National scale (17 different centers) takes place in a practice standardization prospect.
General methodology :
In each participating center, one of the 3 strategies for the sentinel LN analysis is currently used (with or without extemporaneous procedure).
Cost-effect evaluation will inventory all undertaken costs in each strategy and all induced positive or negative consequences, both at a qualitative and quantitative level using micro costing and macro costing evaluations. Evaluation of Quality of Life adjusted to health will be included to the cost effect analysis.
In our study, population studied with a localized breast carcinoma, are women aged between 18 and 65 years old and likely to be active : inclusion criteria are strictly the same in the 3 strategies studied.
In our study, we will consider Hospital and Health Insurance point of view. Hospital prospect will identify and value the cost paid by health institution due to the use of any of these 3 techniques.
Insurance Health prospect will value the costs of each treatment strategy including direct costs related to private medical care and not only those to be reimbursed to the hospital.
The study starts at the time of the sentinel LN excision and ends 9 months later, including the post-operative complications and the possible second surgery for axillary LN excision.
At all 920 patients will be included in the 20 participating team.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OSNA | Experimental | Procedure: SLN detection +/- complementary axillary lymphadenectomyIntra operative sentinel lymph-node sampling. In this experimental arm, the molecular biology technique is only used through the OSNA technique (One Step Nuclear Acid analysis), and no other classical pathology's diagnosis method such as formalin fixation, then parraffin embedding before slices cutting, hematoxylin-eosin-safran staining or any other immunohistochemical stainings. According to the results of the staging procedure, the treatment in this arm is decided in conformity with local and national guidelines in breast cancer treatments. SLN detection +/- complementary axillary lymphadenectomy is immediately decided if a tumor invasion is detected within the sentinel LN material. |
| PATHOLOGICAL ANALYSIS | Other | Procedure: SLN detection +/- complementary axillary lymphadenectomyNo intra operative examination is performed in this arm, but the final pathological examination: In this arm, the classical pathology's diagnosis method is starting with a formalin fixation of suspected invaded lymph-nodes sampling at least 24Hrs; then parraffin embedding before slices cutting; then hematoxylin-eosin-safran staining or any other immunohistochemical stainings. According to the results of the staging procedure, the treatment in this arm is decided in conformity with local and national updated guidelines in breast cancer treatments. SLN detection +/- complementary axillary lymphadenectomy: is decided in a second surgical step when the pathologic analysis has detected a tumor invasion |
| EXTEMPORANEOUS | Other | Procedure: SLN detection +/- complementary axillary lymphadenectomy"Intra-operative" pathological frozen sections of sentinel LN samples are coloured and examined immediately by the pathologist, allowing an immediate result at the disposal of the surgeon who can decide to complete by an axillary LN dissection or not. Then the remaining material will be prepared similarly as in the pathological classical method (Arm B), ie formalin fixation, then parraffin embedding, then slices cutting, then HES staining or ImmunoHistochemistry for a final diagnosis. SLN detection +/- complementary axillary lymphadenectomy: is decided immediately when the tumor invasion is detected in the sentinel LN material. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Infiltrating breast carcinoma histologically proven (lobular, ...)
- unifocal,
- T <3 cm (clinical), palpable or non-palpable tumor (smaller than a centimetre allowed),
- N0 clinical axillary
- Conservative surgery,
Key exclusion criteria (10 listed)
- Recurrence of breast carcinoma,
- History of ipsilateral breast reduction surgery,
- Radical surgery.
- History of lumpectomy
- Neoadjuvant chemotherapy
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 |
|---|---|---|
| SLN detection +/- complementary axillary lymphadenectomyAlso: Surgical complementary dissection of axillary lymph-node.breast cancer surgery with SLN detection +/- complementary axillary lymphadenectomy Whatever the detection method used in the lab (Arm A: OSNA; Arm B: Pathological Examination; Arm C: Extemporaneous) to assess the positivity of sentinel lymph-node invasion, if negative result (no tumor invasion in the sentinel LN), a complementary lymph-node dissection is not mandatory if positive result (tumor invasion in the sentinel LN), a complementary lymph-node dissection is performed, either immediately (Arm A and C) or in a second surgical procedure (Arm B) | Procedure or surgery | EXTEMPORANEOUS, OSNA, PATHOLOGICAL ANALYSIS |
Primary outcome
Medico-economic study : medical cost between 3 different sentinel lymph node analysis (histological analysis or molecular biology) in the management of patients treated for invasive breast carcinoma.
Time frame: from surgery to 9 mounths later
Several phases are differences to compare the costs of three strategies: * surgery * hospitalization * follow-up
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 29 Apr 2022.
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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.
Virginie BORDES, MD study director
Institut de Cancérologie de l'Ouest (ICO) - Nantes, France
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLN detection +/- complementary axillary lymphadenectomy in people with Breast Cancer and Surgery, run by Institut Cancerologie de l'Ouest at 17 sites 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 9 inclusion and 10 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 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
Medico-economic study : medical cost between 3 different sentinel lymph node analysis (histological analysis or molecular biology) in the management of patients treated for invasive breast carcinoma. (time frame: from surgery to 9 mounths later). 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 29 Apr 2022.