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The Memorial Sloan-Kettering Cancer Center (MSKCC (NOTEGS)

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ClinicalTrials.gov Identifier: NCT01509963
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : August 5, 2013
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date December 6, 2011
First Posted Date January 13, 2012
Last Update Posted Date August 5, 2013
Study Start Date December 2011
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 10, 2012)
False negative rate in patients with both a ≤ 10% probability of metastatic non-SN with the MSKCC nomogram and a Tenon score ≤ 3.5 (i.e. low risk): proportion of patients with metastatic non-SN at additional ALND. [ Time Frame: after the surgery ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01509963 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 10, 2012)
  • To determine the impact on the reliability of the combined predictor of frozen section examination in light of his achievement or not, and its sensitivity. [ Time Frame: after the surgery ]
  • To allow, because of the large number of patients to include in the study, the diffusion of a charter of quality for the SN procedure. [ Time Frame: after the surgery ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Memorial Sloan-Kettering Cancer Center (MSKCC
Official Title Prospective Evaluation of the Reliability of the Combined Use of Two Models to Predict Non-sentinel Lymph Node Status in Breast Cancer Patients With Metastatic Sentinel Lymph Nodes: the MSKCC Nomogram and the Tenon Score.
Brief Summary The purpose of this study is to prospectively evaluate the combined use of the MSKCC nomogram (Memorial Sloan-Kettering Cancer Center) and Tenon score to select, in patients with metastatic sentinel lymph node (SN), those at low risk of metastatic non-SN in whom additional axillary lymph node dissection (ALND) could be avoided.
Detailed Description

EXPERIMENTAL PLAN AND COURSE OF STUDY This is a prospective non-randomized non-interventional multicenter study including the respect of a quality charter and involving a prospective registration of clinical and histological data to test the hypothesis of a proportion of false negative rate (=rate of metastatic SN) of 5% +/- 5% within the population at low risk by the combined use of the MSKCC nomogram and Tenon score. No modification therapy will be conducted because the scores will not be provided to operators.

6.1 Conduct of the study 6.1.1 Before and during surgery Every surgeon agreeing to participate in the study - and thus to respect the quality charter - will make the inclusion of his eligible patients with an e-CRF which will generate automatically a number of anonymity. A form of inclusion specifying the number of anonymity of the patient, the initials of the name and the first name as well as the date of birth of the patient will be send back by e-mail by the study coordinator and clinical study technician (CST) of the URC-Est. The surgeon will have at his disposal 60 boards of labels of anonymity elaborated by the CST of the URC-Est corresponding to 30 patients (2 boards of labels by patient). The resupplying of labels will be managed by the CST.

A label will contain i) the number of anonymity, ii) the address and phone number of the surgeon, iii) the address and phone number of the pathology laboratory, iv) the address and phone number of the study coordinator including fax number where pathological results should be send.

During the first intervention, the surgeon will send the histological specimen (i.e. lumpectomy or mastectomy, SN, and possibly non-SN in case the ALND is completed during the first surgical procedure with a board of labels of anonymity.

In case of additional surgical procedure to complete ALND, the histological specimen (i.e. non-SN) will be sent to the pathology laboratory with the second board of label of anonymity corresponding to this patient.

The laboratory of pathology will have to label with anonymity labels all histological reports that should be sent to the study coordinator. To eventually calculate combined prediction (MSKCC nomogram and Tenon score) and ensure respect of the quality charter, specific data must appear in the pathology report:

  • Clinical information: age of the patient, the location of the primitive tumor (upper outer quadrant, SUPERO-medial, INFERO-lateral, INFERO-internal retroareolar or other), palpable tumor or not, the results of histological or cytological diagnosis performed preoperatively.
  • Regarding the number of lumpectomy: size of invasive cancer (largest diameter), histologic type, associated intra ductal carcinoma (type and percentage), existence of vascular or lymphatic emboli, estrogen receptor status, progesterone receptor status, HER-2-neu status, SCAFF and Bloom-Richardson grade or equivalent, if realized, the level of expression of antigen Ki 67; regarding sentinel lymph nodes: number of SN harvested ; for each metastatic SN: type of metastasis: macrometastasis, micrometastasis, isolated cells, method of intraoperative diagnosis of metastasis (if performed): frozen section, cytology, RT-PCR. Final pathologic exam: routine H&E, serial sectioning H&E, IHC. Regarding non-sentinel lymph nodes: number of non-SN
  • number of metastatic non-SN, postoperative TNM. 6.1.2 Collection of histological results from the pathology laboratories The study data will be informed through pathology reports. Ten weeks after receiving the e-CRF, the CST of the URC-EST under the responsibility of the study coordinator will contact the pathology laboratory. The latter will label with anonymity labels all histology reports corresponding to the first and possibly, if an additional ALND has further been done, and will fax reports to the study coordinator(fax number on the label).

6.2 Procedure to calculate the risk of non-SN involvement A calculation of the probability of metastatic non-SN using the MSKCC nomogram and the the Tenon score will be performed for all patients. Calculations will be implemented under the responsibility of coordinating doctor.

The result of these calculations will not be communicated to surgeons. 6.2.1 Calculating the score of Tenon

  • Variable 1: Existence of macrometastasis in a non-SN: if macrometastases, 2 points are assigned, 0 otherwise.
  • Variable 2: histological size of invasive tumor: 3 points if the tumor is greater than 20 mm, 1.5 points if the size is in 10 and 20 mm and 0 points if less than 10 mm.
  • Variable 3: Ratio between the number of metastatic SN (whatever the type of metastasis (macrometastasis, micrometastasis or isolated tumor cells)) and the number of SN harvested: 2 points if the ratio is 1; 1 point if between 0.5 and 1, and 0 points if less than 0.5.

The scores for the 3 variables are then added together to calculate the score of Tenon.

6.2.2 Calculation of risk by the MSKCC nomogram This calculation involves 8 variables: 1) histological type associated with SBR grade (infiltrating ductal carcinoma grade 1, grade 2, grade 3 and invasive lobular carcinoma (ILC)), 2) the existence of a LYMPHO-vascular invasion (LVI) (yes, no), 3) the multifocal nature of the tumor (yes, no), 4) status of estrogen receptor (present, absent), 4) the number of non-metastatic SN (0 to 14), 5) the number of metastatic SN (from 1 to 7), 6) the size of the tumor (from 0 to 9 cm), 7) method of detecting metastases in the SN. For the latter, there are 2 different situations: when using the technique CRYOCONGELATION, 4 items were proposed (CRYOCONGELATION analysis, analysis by H&E : routine H&E and serial sectioning H&E, and IHC), and in the absence of use of technology by cryocongelation only 3 items were proposed (analysis by H&E : routine H&E and serial sectioning H&E, and IHC).

  1. The calculation must be done using the calculator developed by the authors and easily accessible on the website http://www.mskcc.org/MSKCC/htlm/5794.cfm.

    • First Row "Performed Frozen Section. The item must be checked if the pathologist has performed frozen section intra-operatively. Otherwise, the item must not be checked.
    • Second line "Pathological size (cm)" must refer the histological size of the largest tumor diameter in centimeters.
    • Third line "Tumor type and grade": you must select the corresponding item from the 4 items offered: ductal I (for infiltrating ductal carcinoma (TCC) grade 1), ductal II (for TCC grade 2), ductal III (for TCC grade 3) and lobular (for infiltrating lobular carcinoma).
    • Fourth line "Number of Positive Sentinel Lymph Nodes" must report the number of metastatic SN, whatever the type of flooding (by macrometastasis a micrometastasis or isolated cells).
    • Fifth line "SN Method of Detection": you must select the item. Two scenarios:

      1. In the first line item "Frozen Section Performed" was checked: 4 item are then offered: Frozen (if the metastasis was diagnosed at the frozen section). However, this scenario can not produce it because in this case, the patient has received ALND in the same operation as the procedure of SN; Routine (if the metastasis was diagnosed by analyzing routine H&E), Serial (if the metastasis was diagnosed after serial sectioning in H&E), IHC (if the metastasis was diagnosed by IHC)
      2. the first line item "Frozen Section Performed" was not checked: 3 item are then proposed: Routine (if the metastasis was diagnosed by analyzing routine H&E), Serial (if the metastasis was diagnosed after serial sectioning in H&E), IHC (if the metastasis was diagnosed by IHC).
    • Sixth row "Number of Negative Sentinel Lymph Nodes': the number of non-metastatic SN.
    • Seventh row "Lymphovascular Invasion." The item must be checked in case of lymphatic or vascular emboli.
    • Eighth row "Multifocality. The item must be checked in case of multifocality.
    • Ninth Line "Estrogen Receptor Positive". The item must be checked if the tumor estrogen receptors.
  2. The use of the nomogram (defined as the graphical representation of the model) is not recommended because the calculation is less precise than the web interface.

6.2.3 Risk calculation combining the MSKCC nomogram and the Tenon score

  • Group at low risk of metastatic non-SN: probability with the MSKCC nomogram of ≤ 10% and a score of Tenon ≤ 3.5.
  • Group at risk of metastatic non-SN: probability with the MSKCC nomogram of > 10% and/or Tenon score > 3.5.

6.3 Monitoring of patients included in the study The study evaluates the combined use of two predictors at baseline. It does not require monitoring. However, all patients will be monitored regularly for any breast cancer and adjuvant treatment of breast cancer will remain unchanged by this study.

6.4 Total time of research The recruitment and the opening of study centers is planned over a period of 6 months. Inclusion of patients is planned over a period of 18 months. The total duration of the study is 24 months.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study will focus on patients candidates for the SN procedure as recommended by Saint-Paul de Vence initially in 2005 but modified in 2009.
Condition Breast Cancer
Intervention Other: no intervention : measure of score
To provide probability of non sentinel lymph node metastasis in case of metastatic lymph node according to MSKCC nomogram and Tenon score.
Study Groups/Cohorts patients candidates for the SN procedure
The study will focus on patients candidates for the SN procedure as recommended by Saint-Paul de VENCE initially in 2005 but modified in 2009.
Intervention: Other: no intervention : measure of score
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 2, 2013)
3194
Original Estimated Enrollment
 (submitted: January 10, 2012)
2820
Actual Study Completion Date July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients aged over 18 years old with invasive breast cancer with an indication of SN procedure as recommended by Saint-Paul de VENCE in 2005 amended in 2009
  • T1-2 breast cancer
  • Patients having social security coverage.

Exclusion Criteria:

  • Patient under the age of 18.
  • Patient who had neoadjuvant chemotherapy.
  • Patient who had had radiotherapy to the ipsilateral axilla or breast.
  • Pregnant patient.
  • Patients who do not speak French.
  • Patients refusing to participate in the study.
  • Simultaneous participation in another research period of exclusion
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01509963
Other Study ID Numbers NI 10073
AOM 10220 ( Other Identifier: Assistance Publique - Hôpitaux de Paris )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Roman Rouzier, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date August 2013