Testing of Different Methods for Determining Whether Breast Cancer Has Spread to the Lymph Nodes
NCT ID: NCT00360152
Last Updated: 2013-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
100 participants
INTERVENTIONAL
2006-08-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Positive Axillary Ultrasound
Positive Axillary Ultrasound -\> Fine Needle Aspiration Biopsy -\> Cytopathology and Reverse Transcription-Polymerase Chain Reaction (RT-PCR) -\> Positive Cyto=Axillary Lymph Node Dissection, Negative Cyto=Sentinel Lymph Node Biopsy -\> Pathology
Fine needle aspiration biopsy (FNAB)
Sentinel Lymph Node Biopsy
Negative Axillary Ultrasound
Negative Axillary Ultrasound -\> Sentinel Lymph Node Biopsy/Fine Needle Aspiration Biopsy -\> Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and Pathology
Fine needle aspiration biopsy (FNAB)
Sentinel Lymph Node Biopsy
Interventions
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Fine needle aspiration biopsy (FNAB)
Sentinel Lymph Node Biopsy
Eligibility Criteria
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Inclusion Criteria
* 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
* Contraindications for breast surgery or biopsy
Patients with no evidence of malignancy scheduled to undergo procedures under general anesthesia must fulfill the following eligibility requirements:
* Female patients, aged 18 and over
* Patient must be scheduled to undergo a procedure under general anesthesia with access to lymph nodes that can be biopsied by FNA biopsy at minimal risk to the patient
* Patient must be willing to give informed consent
* Patient with no history of malignancy
18 Years
FEMALE
No
Sponsors
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Society for Surgical Oncologists
UNKNOWN
Sysmex America, Inc.
INDUSTRY
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Julie A. Margenthaler, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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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. doi: 10.1002/1097-0142(197803)41:33.0.co;2-i.
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. doi: 10.1056/NEJM199810013391401.
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. doi: 10.1200/JCO.2000.18.13.2560.
Ung OA. Australasian experience and trials in sentinel lymph node biopsy: the RACS SNAC trial. Asian J Surg. 2004 Oct;27(4):284-90. doi: 10.1016/S1015-9584(09)60052-X.
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. doi: 10.1200/JCO.2005.03.228.
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. doi: 10.1053/j.seminoncol.2004.03.019.
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. doi: 10.1056/NEJMoa020128.
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. 2004 Oct;108(4):345-55. English, Italian.
Deurloo EE, Tanis PJ, Gilhuijs KG, Muller SH, Kroger R, Peterse JL, Rutgers EJ, Valdes 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. doi: 10.1016/s0959-8049(02)00748-7.
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. doi: 10.1002/cncr.10786.
Parker SH, Dennis MA, Kaske TI. Identification of the sentinel node in patients with breast cancer. Radiol Clin North Am. 2000 Jul;38(4):809-23. doi: 10.1016/s0033-8389(05)70202-5.
Bude RO. Does contrast-enhanced US have potential for sentinel lymph node detection? Radiology. 2004 Mar;230(3):603-4. doi: 10.1148/radiol.2303031683. 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. doi: 10.1148/radiol.2303021440.
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. doi: 10.1097/01.sla.0000128687.59439.d6.
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. doi: 10.1158/1078-0432.CCR-04-2164.
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. doi: 10.1038/sj.bjc.6600190.
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. doi: 10.1002/ijc.1312.
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. doi: 10.1373/49.2.312. 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. doi: 10.1378/chest.127.2.430.
Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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06-0530 / 201109077
Identifier Type: -
Identifier Source: org_study_id
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