NCT02056886: SAGE

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

Completed NA Last updated 29 April 2022

What this trial tests

NA trial testing SLN detection +/- complementary axillary lymphadenectomy in Breast Cancer in 858 participants. Completed in 15 February 2022.

Timeline

21 October 2013

Primary endpoint
2 January 2018

15 February 2022

Quick facts

Lead sponsor	Institut Cancerologie de l'Ouest
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	858
Start date	21 October 2013
Primary completion	2 January 2018
Estimated completion	15 February 2022
Sites	17 locations across France

Drugs / interventions tested

• SLN detection +/- complementary axillary lymphadenectomy

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Surgery — all drugs for Surgery →

Sponsor

Institut Cancerologie de l'Ouest — full company profile →

Who can join

Adults 18 to 65, female only, with Breast Cancer or Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.