GeneSearch™ Breast Lymph Node (BLN) Assay China Registration Study

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00869674
• Other study ID #: OCD-200804
• Secondary ID: CBCSG-001a
• Status: Terminated
• Phase: Phase 3
• First received: March 25, 2009
• Last updated: May 29, 2013
• Start date: February 2009
• Est. completion date: November 2009

Study information

• Verified date: June 2009
• Source: Johnson & Johnson Medical, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 540
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Southwest Hospital	Chongqing	Sichuan
China	Guangdong General Hospital	Guangdong	Guangdong
China	Second affiliated hospital of Zhongshan University	Guangzhou	Guangdong
China	China Shandong Cancer hospital	Jinan	Shandong
China	Shanghai Cancer Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Medical, China

Country where clinical trial is conducted

China, 

References & Publications (22)

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. — View Citation

Anderson TJ. The challenge of sentinel lymph node biopsy. Histopathology. 1999 Jul;35(1):82-4. Review. — View Citation

Backus J, Green GA, XU M, et al. Intra-operative molecular analysis of sentinel lymph nodes for the management of breast Cancer surgery. Clin Cancer Res; 2005

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1200/JCO.2007.14.0665. — View Citation

Krag D. Current status of sentinel lymph node surgery for breast cancer. J Natl Cancer Inst. 1999 Feb 17;91(4):302-3. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. doi: 10.1200/JCO.2007.13.0179. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		9 months	No
Secondary	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.		9 months	No