GeneSearch™ Breast Lymph Node (BLN) Assay China Registration Study - Full Text View

Purpose

The primary objective of this trial is to compare GeneSearch™ Breast Lymph Node (BLN) Test Kit to permanent pathological section, so as to evaluate the clinical sensitivity and specificity of GeneSearch™ Breast Lymph Node (BLN) Test Kit in detecting axillary sentinel lymph node metastases in breast cancer patients.

The secondary objective of this trial is to evaluate the positive predictive value and negative predictive value of GeneSearch™ Breast Lymph Node (BLN) Test Kit when used in the detection of axillary sentinel lymph node metastases in breast cancer patients.

Prospective and multi-center clinical trial

Condition	Intervention	Phase
Breast Cancer	Procedure: GeneSearch™ Breast Lymph Node (BLN) Assay	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	一项比较GeneSearch 乳腺淋巴结（BLN）检测试剂盒和永久病理切片检测乳腺癌患者腋窝前哨淋巴结转移的前瞻性、多中心临床试验 A Prospective and Multi-center Clinical Trial By Comparing GeneSearch™ Breast Lymph Node (BLN) Test Kit To Permanent Pathological Section On Detecting Axillary Sentinel Lymph Node Metastases In Breast Cancer Patients

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Medical, China:

Primary Outcome Measures:

To compare GeneSearch™ BLN Test Kit to permanent pathological section to evaluate the clinical sensitivity and specificity of GeneSearch™ BLN Test Kit in detecting axillary sentinel lymph node metastases in breast cancer patients. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the positive predictive value and negative predictive value of GeneSearch™ BLN Test Kit when used in the detection of axillary sentinel lymph node metastases in breast cancer patients. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment:	540
Study Start Date:	February 2009
Study Completion Date:	November 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Routine pathologic method Half of each sentinal lymph node will have rountine pathologic examination as normal practice.
Experimental: GeneSearch BLN Assay Half of each sentinal lymph node will have GeneSearch BLN testing.	Procedure: GeneSearch™ Breast Lymph Node (BLN) Assay Each of the sentinal lymph node will be divided in half according to cutting scheme. Half of the sentinal lymph node will be tested using rountine pathological method as normal practice, half of the node will have GeneSearch BLN testing. Other Names: GeneSearch Pathology

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed previously as breast cancer
patient scheduled for sentinel lymph node dissection
18 years or older
female or male, and
able and willing to give consent to participate in the study

Exclusion Criteria:

Patients taking part in other research studies that would interfere with their full participation in this study, or
Prior sentinel or partial axillary lymphadenectomy on the same body side

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869674

Locations

China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100035
China, Guangdong
Guangdong General Hospital
Guangdong, Guangdong, China, 510080
Second affiliated hospital of Zhongshan University
Guangzhou, Guangdong, China
China, Shandong
China Shandong Cancer hospital
Jinan, Shandong, China, 250117
China, Sichuan
Southwest Hospital
Chongqing, Sichuan, China, 400038
China
Shanghai Cancer Hospital
Shanghai, China, 200032

Sponsors and Collaborators

Johnson & Johnson Medical, China

Investigators

Principal Investigator:

Yongsheng Wang, MD

Shandong Cancer Hospital

More Information

Publications:

Valagussa P, Bonadonna G, Veronesi U. Patterns of relapse and survival following radical mastectomy. Analysis of 716 consecutive patients. Cancer. 1978 Mar;41(3):1170-8.

Fisher B, Bauer M, Wickerham DL, Redmond CK, Fisher ER, Cruz AB, Foster R, Gardner B, Lerner H, Margolese R, et al. Relation of number of positive axillary nodes to the prognosis of patients with primary breast cancer. An NSABP update. Cancer. 1983 Nov 1;52(9):1551-7.

Albertini JJ, Lyman GH, Cox C, Yeatman T, Balducci L, Ku N, Shivers S, Berman C, Wells K, Rapaport D, Shons A, Horton J, Greenberg H, Nicosia S, Clark R, Cantor A, Reintgen DS. Lymphatic mapping and sentinel node biopsy in the patient with breast cancer. JAMA. 1996 Dec 11;276(22):1818-22.

Giuliano AE, Dale PS, Turner RR, Morton DL, Evans SW, Krasne DL. Improved axillary staging of breast cancer with sentinel lymphadenectomy. Ann Surg. 1995 Sep;222(3):394-9; discussion 399-401. Review.

Morton DL. Intraoperative lymphatic mapping and sentinel lymphadenectomy: community standard care or clinical investigation? Cancer J Sci Am. 1997 Nov-Dec;3(6):328-30. Review. No abstract available.

Yared MA, Middleton LP, Smith TL, Kim HW, Ross MI, Hunt KK, Sahin AA. Recommendations for sentinel lymph node processing in breast cancer. Am J Surg Pathol. 2002 Mar;26(3):377-82.

Schrenk P, Rieger R, Shamiyeh A, Wayand W. Morbidity following sentinel lymph node biopsy versus axillary lymph node dissection for patients with breast carcinoma. Cancer. 2000 Feb 1;88(3):608-14.

Treseler PA, Tauchi PS. Pathologic analysis of the sentinel lymph node. Surg Clin North Am. 2000 Dec;80(6):1695-719. Review.

Van Diest PJ, Torrenga H, Borgstein PJ, Pijpers R, Bleichrodt RP, Rahusen FD, Meijer S. Reliability of intraoperative frozen section and imprint cytological investigation of sentinel lymph nodes in breast cancer. Histopathology. 1999 Jul;35(1):14-8.

Veronesi U, Paganelli G, Galimberti V, Viale G, Zurrida S, Bedoni M, Costa A, de Cicco C, Geraghty JG, Luini A, Sacchini V, Veronesi P. Sentinel-node biopsy to avoid axillary dissection in breast cancer with clinically negative lymph-nodes. Lancet. 1997 Jun 28;349(9069):1864-7.

Veronesi U, Paganelli G, Viale G, Galimberti V, Luini A, Zurrida S, Robertson C, Sacchini V, Veronesi P, Orvieto E, De Cicco C, Intra M, Tosi G, Scarpa D. Sentinel lymph node biopsy and axillary dissection in breast cancer: results in a large series. J Natl Cancer Inst. 1999 Feb 17;91(4):368-73.

Viale G, Bosari S, Mazzarol G, Galimberti V, Luini A, Veronesi P, Paganelli G, Bedoni M, Orvieto E. Intraoperative examination of axillary sentinel lymph nodes in breast carcinoma patients. Cancer. 1999 Jun 1;85(11):2433-8.

Anderson TJ. The challenge of sentinel lymph node biopsy. Histopathology. 1999 Jul;35(1):82-4. Review. No abstract available.

Krag D. Current status of sentinel lymph node surgery for breast cancer. J Natl Cancer Inst. 1999 Feb 17;91(4):302-3. No abstract available.

Turner RR, Hansen NM, Stern SL, Giuliano AE. Intraoperative examination of the sentinel lymph node for breast carcinoma staging. Am J Clin Pathol. 1999 Nov;112(5):627-34.

Lockett MA, Metcalf JS, Baron PL, O'Brien PH, Elliott BM, Robison JG, Cole DJ. Efficacy of reverse transcriptase-polymerase chain reaction screening for micrometastic disease in axillary lymph nodes of breast cancer patients. Am Surg. 1998 Jun;64(6):539-43; discussion 543-4.

Julian TB, Blumencranz P, Deck K, Whitworth P, Berry DA, Berry SM, Rosenberg A, Chagpar AB, Reintgen D, Beitsch P, Simmons R, Saha S, Mamounas EP, Giuliano A. Novel intraoperative molecular test for sentinel lymph node metastases in patients with early-stage breast cancer. J Clin Oncol. 2008 Jul 10;26(20):3338-45.

Bernstein JL, Godbold JH, Raptis G, Watson MA, Levinson B, Aaronson SA, Fleming TP. Identification of mammaglobin as a novel serum marker for breast cancer. Clin Cancer Res. 2005 Sep 15;11(18):6528-35.

Zehentner BK, Carter D. Mammaglobin: a candidate diagnostic marker for breast cancer. Clin Biochem. 2004 Apr;37(4):249-57. Review.

Schoenfeld A, Kruger KH, Gomm J, Sinnett HD, Gazet JC, Sacks N, Bender HG, Luqmani Y, Coombes RC. The detection of micrometastases in the peripheral blood and bone marrow of patients with breast cancer using immunohistochemistry and reverse transcriptase polymerase chain reaction for keratin 19. Eur J Cancer. 1997 May;33(6):854-61.

Turner RR, Weaver DL, Cserni G, Lester SC, Hirsch K, Elashoff DA, Fitzgibbons PL, Viale G, Mazzarol G, Ibarra JA, Schnitt SJ, Giuliano AE. Nodal stage classification for breast carcinoma: improving interobserver reproducibility through standardized histologic criteria and image-based training. J Clin Oncol. 2008 Jan 10;26(2):258-63.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Liu YH, Xu FP, Liao N, Li L, Zhang GC, Zhuang HG, Mei P, Xu J, Zhu XL, Luo XL, Kuang LJ. Efficacy of intraoperative GeneSearch Breast Lymph Node (BLN) Assay for breast cancer metastasis detection in sentinel lymph node in Chinese patients. Cancer Sci. 2010 Aug;101(8):1920-4. Epub 2010 Jan 17.

Responsible Party:	Johnson & Johnson Medical, China
ClinicalTrials.gov Identifier:	NCT00869674 History of Changes
Other Study ID Numbers:	OCD-200804, CBCSG-001a
Study First Received:	March 25, 2009
Last Updated:	May 29, 2013
Health Authority:	China: Food and Drug Administration

Keywords provided by Johnson & Johnson Medical, China:

GeneSearch
Breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013