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Axillary Sentinel Lymph Node Detection in Breast Cancers > 2 cm (GAS2PLUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00636467
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : September 26, 2012
Sponsor:
Collaborator:
PHRC 2007: financial support
Information provided by (Responsible Party):
Centre Leon Berard

Brief Summary:

The purpose of this study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection).

Eligible patients will only be registered (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 25 months (24 months for patient inclusion + 1 month for reception of results). The maximum participation duration of each patient is 1 month.

The number of patients required in this multicentric and prospective study is 240 (16 participating centers).


Condition or disease Intervention/treatment Phase
Breast Cancer Other: No name Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Technique of Axillary Sentinel Lymph Node (SLN) Detection in Breast Cancers > 2 cm
Study Start Date : March 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: No label
Injection of Nanocis® or Nanocoll® (Tc-colloid) on the day before surgery followed by lymphoscintigraphy (long protocol, method n°1) or injection of Nanocis® or Nanocoll® on the morning of the surgery followed by lymphoscintigraphy at least 2h30 later (short protocol, method n° 2)
Other: No name
Injection of Nanocis® or Nanocoll® on the day before surgery followed by lymphoscintigraphy (long protocol, method n°1) or injection of Nanocis® or Nanocoll® on the morning of the surgery followed by lymphoscintigraphy at least 2h30 later (short protocol, method n° 2)




Primary Outcome Measures :
  1. Quality criteria of the SLN detection technique [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Total number of sampled SLN per patient [ Time Frame: 1 month ]
  2. Detection of SLN by means of extra-axillary markings (lymphoscintigraphy) [ Time Frame: 1 month ]
  3. Histopathological results (SLN) [ Time Frame: 1 month ]
  4. Histopathological results (dissection) [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female, age ≥ 18 years
  • Patient with invasive unifocal breast cancer with tumor size > 2 cm at initial examination (clinical examination and/or imaging)
  • Preoperative histological diagnosis of infiltrating mammary carcinoma
  • No lymph node at clinical examination
  • No treatment for this cancer before surgery
  • Mandatory affiliation with a social security system
  • Written, signed informed consent

Exclusion Criteria:

  • No invasive breast cancer
  • Breast tumor =< 2 cm
  • Preoperative histological diagnosis other than infiltrating mammary carcinoma
  • Multifocal breast cancer
  • Inflammatory breast cancer
  • Metastatic cancer
  • History of homolateral breast surgery
  • History of allergic disorders
  • History of homolateral breast cancer
  • Difficult follow-up
  • Pregnant or lactating woman
  • Previous inclusion in the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636467


Locations
Show Show 22 study locations
Sponsors and Collaborators
Centre Leon Berard
PHRC 2007: financial support
Investigators
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Principal Investigator: Hervé MIGNOTTE, MD Centre Leon Berard, Lyon

Publications of Results:
Edwards M, Giuliano A, Reintgen D, Tafra L. Consensus statement on guidelines for performance of sentinel lymph node biopsy for breast cancer. Am Soc Breast Surg Q. Press Release, 1998 ;Fall :3

Other Publications:

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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT00636467    
Other Study ID Numbers: GAS2PLUS
ET2007-045
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012
Keywords provided by Centre Leon Berard:
Breast cancer (tumors> 2 cm)
Detection
Axillary sentinel lymph node
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases