| August 2, 2006 |
| February 18, 2009 |
| July 2006 |
| July 2008 (final data collection date for primary outcome measure) |
| The primary outcomes include axillary ultrasound findings, the expressing levels for each of the tumor-associated candidate markers by RT-PCR, as well as the "true" status of the axilla as based on pathologic findings. [ Time Frame: 36 months ] [ Designated as safety issue: No ] |
| The primary outcomes include axillary ultrasound findings, the expressing levels for each of the tumor-associated candidate markers by RT-PCR, as well as the “true” status of the axilla as based on pathologic findings. |
| Complete list of historical versions of study NCT00360152 on ClinicalTrials.gov Archive Site |
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| Testing of Different Methods for Determining Whether Breast Cancer Has Spread to the Lymph Nodes |
| Minimally Invasive Staging of the Axilla in Breast Cancer: A Pilot Study to Assess the Feasibility of Axillary Ultrasound, and Fine Needle Aspiration Biopsy and Molecular Analysis |
Sentinel lymph node biopsy (SLNB) has recently emerged as a less invasive alternative to axillary lymph node dissection (ALND) in the treatment of breast cancer. However, SLNB has a number of limitations, and we believe that alternative strategies for staging of the axilla should be explored. The hypothesis of this proposal is that the combination of preoperative high-resolution axillary ultrasound (AUS), fine needle aspiration biopsy (FNAB), and molecular analysis using real-time reverse transcription-polymerase chain reaction (RT-PCR) represents a viable, minimally invasive alternative to SLNB. We propose a prospective cohort study to rigorously assess the diagnostic accuracy of molecular analysis of AUS-FNAB specimens. Eighty female patients with pathologically confirmed, clinically node-negative invasive breast cancer who are considered to be candidates for SLNB will be eligible for enrollment. The primary endpoint of this study is to determine the feasibility of AUS-FNAB and real-time RT-PCR to predict the pathologic status of the axilla in a proof-of-principle study. In the short term, validation of this innovative strategy is likely to reduce the number of sentinel node procedures. In the long term, we believe that AUS-FNAB may ultimately replace SLNB. |
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| Interventional |
| Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Breast Neoplasms |
- Procedure: Fine needle aspiration biopsy
- Procedure: Sentinel Lymph Node Biopsy/Fine Needle Aspiration Biopsy
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- Active Comparator: Positive Axillary Ultrasound
- Active Comparator: Negative Axillary Ultrasound
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- 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.
- Krag D, Weaver D, Ashikaga T, Moffat F, Klimberg VS, Shriver C, Feldman S, Kusminsky R, Gadd M, Kuhn J, Harlow S, Beitsch P. The sentinel node in breast cancer--a multicenter validation study. N Engl J Med. 1998 Oct 1;339(14):941-6.
- McMasters KM, Tuttle TM, Carlson DJ, Brown CM, Noyes RD, Glaser RL, Vennekotter DJ, Turk PS, Tate PS, Sardi A, Cerrito PB, Edwards MJ. Sentinel lymph node biopsy for breast cancer: a suitable alternative to routine axillary dissection in multi-institutional practice when optimal technique is used. J Clin Oncol. 2000 Jul;18(13):2560-6.
- Ung OA. Australasian experience and trials in sentinel lymph node biopsy: the RACS SNAC trial. Asian J Surg. 2004 Oct;27(4):284-90.
- Purushotham AD, Upponi S, Klevesath MB, Bobrow L, Millar K, Myles JP, Duffy SW. Morbidity after sentinel lymph node biopsy in primary breast cancer: results from a randomized controlled trial. J Clin Oncol. 2005 Jul 1;23(19):4312-21.
- Posther KE, Wilke LG, Giuliano AE. Sentinel lymph node dissection and the current status of American trials on breast lymphatic mapping. Semin Oncol. 2004 Jun;31(3):426-36. Review.
- Fisher B, Jeong JH, Anderson S, Bryant J, Fisher ER, Wolmark N. Twenty-five-year follow-up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation. N Engl J Med. 2002 Aug 22;347(8):567-75.
- Brancato B, Zappa M, Bricolo D, Catarzi S, Risso G, Bonardi R, Cariaggi P, Bianchin A, Bricolo P, Rosselli Del Turco M, Cataliotti L, Bianchi S, Ciatto S. Role of ultrasound-guided fine needle cytology of axillary lymph nodes in breast carcinoma staging. Radiol Med (Torino). 2004 Oct;108(4):345-55. English, Italian.
- Deurloo EE, Tanis PJ, Gilhuijs KG, Muller SH, Kröger R, Peterse JL, Rutgers EJ, Valdés Olmos R, Schultze Kool LJ. Reduction in the number of sentinel lymph node procedures by preoperative ultrasonography of the axilla in breast cancer. Eur J Cancer. 2003 May;39(8):1068-73.
- Krishnamurthy S, Sneige N, Bedi DG, Edieken BS, Fornage BD, Kuerer HM, Singletary SE, Hunt KK. Role of ultrasound-guided fine-needle aspiration of indeterminate and suspicious axillary lymph nodes in the initial staging of breast carcinoma. Cancer. 2002 Sep 1;95(5):982-8.
- Bude RO. Does contrast-enhanced US have potential for sentinel lymph node detection? Radiology. 2004 Mar;230(3):603-4. No abstract available.
- Goldberg BB, Merton DA, Liu JB, Thakur M, Murphy GF, Needleman L, Tornes A, Forsberg F. Sentinel lymph nodes in a swine model with melanoma: contrast-enhanced lymphatic US. Radiology. 2004 Mar;230(3):727-34.
- Wisner ER, Ferrara KW, Short RE, Ottoboni TB, Gabe JD, Patel D. Sentinel node detection using contrast-enhanced power Doppler ultrasound lymphography. Invest Radiol. 2003 Jun;38(6):358-65.
- Gillanders WE, Mikhitarian K, Hebert R, Mauldin PD, Palesch Y, Walters C, Urist MM, Mann GB, Doherty G, Herrmann VM, Hill AD, Eremin O, El-Sheemy M, Orr RK, Valle AA, Henderson MA, Dewitty RL, Sugg SL, Frykberg E, Yeh K, Bell RM, Metcalf JS, Elliott BM, Brothers T, Robison J, Mitas M, Cole DJ. Molecular detection of micrometastatic breast cancer in histopathology-negative axillary lymph nodes correlates with traditional predictors of prognosis: an interim analysis of a prospective multi-institutional cohort study. Ann Surg. 2004 Jun;239(6):828-37; discussion 837-40.
- Mikhitarian K, Gillanders WE, Almeida JS, Hebert Martin R, Varela JC, Metcalf JS, Cole DJ, Mitas M. An innovative microarray strategy identities informative molecular markers for the detection of micrometastatic breast cancer. Clin Cancer Res. 2005 May 15;11(10):3697-704.
- Mitas M, Mikhitarian K, Hoover L, Lockett MA, Kelley L, Hill A, Gillanders WE, Cole DJ. Prostate-Specific Ets (PSE) factor: a novel marker for detection of metastatic breast cancer in axillary lymph nodes. Br J Cancer. 2002 Mar 18;86(6):899-904.
- Mitas M, Mikhitarian K, Walters C, Baron PL, Elliott BM, Brothers TE, Robison JG, Metcalf JS, Palesch YY, Zhang Z, Gillanders WE, Cole DJ. Quantitative real-time RT-PCR detection of breast cancer micrometastasis using a multigene marker panel. Int J Cancer. 2001 Jul 15;93(2):162-71.
- Mitas M, Cole DJ, Hoover L, Fraig MM, Mikhitarian K, Block MI, Hoffman BJ, Hawes RH, Gillanders WE, Wallace MB. Real-time reverse transcription-PCR detects KS1/4 mRNA in mediastinal lymph nodes from patients with non-small cell lung cancer. Clin Chem. 2003 Feb;49(2):312-5. No abstract available.
- Wallace MB, Block MI, Gillanders W, Ravenel J, Hoffman BJ, Reed CE, Fraig M, Cole D, Mitas M. Accurate molecular detection of non-small cell lung cancer metastases in mediastinal lymph nodes sampled by endoscopic ultrasound-guided needle aspiration. Chest. 2005 Feb;127(2):430-7.
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| Active, not recruiting |
| 100 |
| July 2011 |
| July 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Female patients, aged 18 and over.
- Patients must be newly diagnosed with clinical stage I or II breast cancer and be eligible for breast surgery and core breast biopsy of their proven breast carcinoma.
Exclusion Criteria:
- Inability to give informed consent
- Contraindications for breast surgery or biopsy
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| Female |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
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| NCT00360152 |
| Julie Margenthaler, MD, Washington University School of Medicine |
| 06-0530 |
| Washington University School of Medicine |
- Society for Surgical Oncologists
- Sysmex America, Inc.
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| Principal Investigator: |
Julie A. Margenthaler, M.D. |
Washington University School of Medicine |
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| Washington University School of Medicine |
| February 2009 |
