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Medico-economic Study of Three Strategies of Sentinel Lymph Node Analysis in Operable Breast Cancer (SAGE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Institut Cancerologie de l'Ouest
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier:
NCT02056886
First received: February 5, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Cancer
Surgery
Procedure: SLN detection +/- complementary axillary lymphadenectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Institut Cancerologie de l'Ouest:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    Several phases are differences to compare the costs of three strategies:

    • surgery
    • hospitalization
    • follow-up


Estimated Enrollment: 920
Study Start Date: July 2013
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OSNA

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.

Procedure: SLN detection +/- complementary axillary lymphadenectomy
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)
Other Name: Surgical complementary dissection of axillary lymph-node.
PATHOLOGICAL ANALYSIS

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

Procedure: SLN detection +/- complementary axillary lymphadenectomy
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)
Other Name: Surgical complementary dissection of axillary lymph-node.
EXTEMPORANEOUS

"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.

Procedure: SLN detection +/- complementary axillary lymphadenectomy
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)
Other Name: Surgical complementary dissection of axillary lymph-node.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infiltrating breast carcinoma histologically proven (lobular, ...)
  2. unifocal,
  3. T <3 cm (clinical), palpable or non-palpable tumor (smaller than a centimetre allowed),
  4. N0 clinical axillary
  5. Conservative surgery,
  6. GS detection by isotopic or combined method,
  7. Age <65 (for more frequent activity), and> 18 years.
  8. Social protection
  9. Signed Informed consent

Exclusion Criteria:

  1. Recurrence of breast carcinoma,
  2. History of ipsilateral breast reduction surgery,
  3. Radical surgery.
  4. History of lumpectomy
  5. Neoadjuvant chemotherapy
  6. Multi-focality
  7. Neoadjuvant hormone therapy
  8. < 18 years old
  9. Pregnant or nursing patient or of childbearing age without effective contraception,
  10. Legal incapacity or limited legal capacity. Medical or psychological conditions not allowing the subject to understand the study and sign the consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02056886

Contacts
Contact: Virginie BORDES, MD +33 2 40 67 99 00 ext 9185 Virginie.Bordes@ico.unicancer.fr
Contact: Francois PEIN, MD +33 2 40 67 99 08 Francois.Pein@ico.unicancer.fr

Locations
France
ICO Paul Papin Recruiting
Angers, France, 49000
Contact: Pedro RARO, MD       pedro.raro@ico.unicancer.fr   
Principal Investigator: Pedro RARO, Md         
ICO René Gauducheau Recruiting
Nantes - St Herblain, France, 44800
Contact: Virginie BORDES, MD    +33 2 40 67 99 00 ext 9185    Virginie.Bordes@ico.unicancer.fr   
Principal Investigator: Virginie BORDES, MD         
Institut Curie Recruiting
Paris, France, 75248
Contact: Séverine ALRAN, MD       severine.alran@curie.net   
Principal Investigator: Séverine ALRAN, MD         
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
Principal Investigator: Virginie BORDES, MD Institut de Cancérologie de l'Ouest (ICO) - Nantes, France
  More Information

No publications provided

Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT02056886     History of Changes
Other Study ID Numbers: ICO-N-2012-08, 2012-A01504-39
Study First Received: February 5, 2014
Last Updated: February 5, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Institut Cancerologie de l'Ouest:
breast cancer, sentinel lymph node, extemporaneous, OSNA

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 19, 2014