Breast CancerGATANCT00293865
Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
A study testing sentinel node and GAS in people with Breast Cancer, run by Institut Cancerologie de l'Ouest at 17 sites in France.
Trial summary
The purpose of this study is to assess the detection rate and false negative rate of sentinel lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- sentinel node and GAS
- Type of treatment
- Surgery or procedure
- How many people
- 203 participants
- Where
- 17 sitesFrance
- Study dates
- Mar 2006to Mar 2012
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Previous conservative surgical biopsy
- Secondary pathological diagnosis of infiltrative cancer
- No clinically involved axillary node (N0)
- No previous neoadjuvant treatment
- Performance status European Cancer Conference (ECCO) Grade ≤ 1
- Patient's written informed consent to participate in the study according to French law
- Surgeon must have performed its learning curve
Who cannot join
- Lack of infiltrative breast carcinoma (in situ) pT4d > N0
- Breast cancer relapse
- Pregnancy
- Known patent blue allergy
- Indication for radical or partial mastectomy
- Patient unable to understand the trial
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Hospîtal
Angers, 49000
Institut Bergonié
Bordeaux, 33076
Hospital
Brest, 29000
Centre Hospitalier
La Roche-sur-Yon, 85000
Centre Oscar Lambret
Lille, 59020
centre Léon Berard
Lyon, 69000
Institut Paoli Calmette
Marseille, 13273
Centre Alexis Vautrin
Nancy, 54000
Hospital
Nancy, 54511
Hopital Lariboisière
Paris, 75 000
Hopital Européen Georges Pompidou
Paris, 75000
Hôpital Tenon
Paris, 75970
Hospital
Poitiers, 86000
Institut Jean Godinot
Reims, 51056
Centre Eugène Marquis
Rennes, 35062
Centre René Gauducheau
Saint-Herblain, 44805
Centre Claudius Regaud
Toulouse, 31052
About this study
Official title: Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
The purpose of this study is to assess the detection rate and false negative rate of sentinel lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.
- Conditions
- Breast Cancer
- Being tested
- sentinel node, GAS
- Keywords
- Breast infiltrative cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sentinel nodeProcedure or surgery
detection of the sentinel node in breast cancer
GASProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
false negatives
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Marc Classe, MD, Principal investigator, Centre Rene Gauducheau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293865
- Sponsor's protocol ID
- BRD 05/11-M
- Acronym
- GATA
- Status last verified
- Apr 2016
- First submitted
- 17 Feb 2006
- Last updated
- 19 Apr 2016
- Results posted
- No
Publications
Renaudeau C, Lefebvre-Lacoeuille C, Campion L, Dravet F, Descamps P, Ferron G, Houvenaeghel G, Giard S, Tunon de Lara C, Dupre PF, Fritel X, Ngo C, Verhaeghe JL, Faure C, Mezzadri M, Damey C, Classe JM. Evaluation of sentinel lymph node biopsy after previous breast surgery for breast cancer: GATA study. Breast. 2016 Aug;28:54-9. doi: 10.1016/j.breast.2016.04.006. Epub 2016 May 20.
PubMed 27214241
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
- ClinicalTrials.gov ID
- NCT00293865
- Acronym / sponsor ID
- GATA / BRD 05/11-M
- Conditions
- Breast Cancer
- Keywords
- Breast infiltrative cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 20 Feb 2006 (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.
The purpose of this study is to assess the detection rate and false negative rate of sentinel lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Previous conservative surgical biopsy
- Secondary pathological diagnosis of infiltrative cancer
- No clinically involved axillary node (N0)
- No previous neoadjuvant treatment
Key exclusion criteria (6 listed)
- Lack of infiltrative breast carcinoma (in situ) pT4d > N0
- Breast cancer relapse
- Pregnancy
- Known patent blue allergy
- Indication for radical or partial mastectomy
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 nodedetection of the sentinel node in breast cancer | Procedure or surgery | – |
| GAS | Procedure or surgery | – |
Primary outcome
false negatives
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 19 Apr 2016.
- Derived from this study: PubMed 27214241Renaudeau C, Lefebvre-Lacoeuille C, Campion L, Dravet F, Descamps P, Ferron G, Houvenaeghel G, Giard S, Tunon de Lara C, Dupre PF, Fritel X, Ngo C, Verhaeghe JL, Faure C, Mezzadri M, Damey C, Classe JM. Evaluation of sentinel lymph node biopsy after previous breast surgery for breast cancer: GATA study. Breast. 2016 Aug;28:54-9. doi: 10.1016/j.breast.2016.04.006. Epub 2016 May 20.
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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.
Jean Marc Classe, MD principal investigator
Centre Rene Gauducheau
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sentinel node and GAS in people with Breast Cancer, 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 8 inclusion and 6 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 19 Apr 2016. 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?
false negatives. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00293865, which also lists 1 linked publication.
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 19 Apr 2016.