A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT00355316

Recruitment Status : Completed

First Posted : July 21, 2006

Last Update Posted : June 21, 2013

Sponsor:

Collaborator:

National Institutes of Health (NIH)

Information provided by (Responsible Party):

Washington University School of Medicine

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Completed
Actual Primary Completion Date :	November 2012
Actual Study Completion Date :	February 2013

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.

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Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91.

Baker MK, Mikhitarian K, Osta W, Callahan K, Hoda R, Brescia F, Kneuper-Hall R, Mitas M, Cole DJ, Gillanders WE. Molecular detection of breast cancer cells in the peripheral blood of advanced-stage breast cancer patients using multimarker real-time reverse transcription-polymerase chain reaction and a novel porous barrier density gradient centrifugation technology. Clin Cancer Res. 2003 Oct 15;9(13):4865-71.

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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.

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.

Mitas M, Hoover L, Silvestri G, Reed C, Green M, Turrisi AT, Sherman C, Mikhitarian K, Cole DJ, Block MI, Gillanders WE. Lunx is a superior molecular marker for detection of non-small cell lung cancer in peripheral blood [corrected]. J Mol Diagn. 2003 Nov;5(4):237-42. Erratum in: J Mol Diagn. 2004 Feb;6(1):58.

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Cassinat B, Zassadowski F, Balitrand N, Barbey C, Rain JD, Fenaux P, Degos L, Vidaud M, Chomienne C. Quantitation of minimal residual disease in acute promyelocytic leukemia patients with t(15;17) translocation using real-time RT-PCR. Leukemia. 2000 Feb;14(2):324-8.

Stathopoulou A, Vlachonikolis I, Mavroudis D, Perraki M, Kouroussis Ch, Apostolaki S, Malamos N, Kakolyris S, Kotsakis A, Xenidis N, Reppa D, Georgoulias V. Molecular detection of cytokeratin-19-positive cells in the peripheral blood of patients with operable breast cancer: evaluation of their prognostic significance. J Clin Oncol. 2002 Aug 15;20(16):3404-12.

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Galán M, Viñolas N, Colomer D, Soler G, Muñoz M, Longarón R, Ventura PJ, Gascón P, Estapé J. Detection of occult breast cancer cells by amplification of CK19 mRNA by reverse transcriptase-polymerase chain reaction: role of surgical manipulation. Anticancer Res. 2002 Sep-Oct;22(5):2877-84.

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Zach O, Kasparu H, Krieger O, Hehenwarter W, Girschikofsky M, Lutz D. Detection of circulating mammary carcinoma cells in the peripheral blood of breast cancer patients via a nested reverse transcriptase polymerase chain reaction assay for mammaglobin mRNA. J Clin Oncol. 1999 Jul;17(7):2015-9.

Bossolasco P, Ricci C, Farina G, Soligo D, Pedretti D, Scanni A, Deliliers GL. Detection of micrometastatic cells in breast cancer by RT-pCR for the mammaglobin gene. Cancer Detect Prev. 2002;26(1):60-3.

Lin YC, Wu Chou YH, Liao IC, Cheng AJ. The expression of mammaglobin mRNA in peripheral blood of metastatic breast cancer patients as an adjunct to serum tumor markers. Cancer Lett. 2003 Feb 28;191(1):93-9.

Zippelius A, Kufer P, Honold G, Köllermann MW, Oberneder R, Schlimok G, Riethmüller G, Pantel K. Limitations of reverse-transcriptase polymerase chain reaction analyses for detection of micrometastatic epithelial cancer cells in bone marrow. J Clin Oncol. 1997 Jul;15(7):2701-8.

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Mikhitarian K, Reott S, Hoover L, Allen A, Cole DJ, Gillanders WE, Mitas M. Enhanced detection of RNA from paraffin-embedded tissue using a panel of truncated gene-specific primers for reverse transcription. Biotechniques. 2004 Mar;36(3):474-8.

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.

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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Mikhitarian, K., W.E. Gillanders, J.S. Almeida, R.H. Martin, J.C. Varela, J.S. Metcalf, D.J. Cole, and M. Mitas. 2005. Relative levels of gene expression are correlated with the ability to detect micrometastatic breast cancer: statistical analysis of data from a multi-institutional prospective cohort study and development of an innovative microarray strategy. Clin Cancer Res In Press.

Mitas M, Almeida JS, Mikhitarian K, Gillanders WE, Lewin DN, Spyropoulos DD, Hoover L, Graham A, Glenn T, King P, Cole DJ, Hawes R, Reed CE, Hoffman BJ. Accurate discrimination of Barrett's esophagus and esophageal adenocarcinoma using a quantitative three-tiered algorithm and multimarker real-time reverse transcription-PCR. Clin Cancer Res. 2005 Mar 15;11(6):2205-14.

Mikhitarian K, Martin RH, Mitas M, Mauldin PD, Palesch Y, Metcalf JS, Cole DJ, Gillanders WE; Mims Study Group. Molecular analysis improves sensitivity of breast sentinel lymph node biopsy: results of a multi-institutional prospective cohort study. Surgery. 2005 Sep;138(3):474-81.

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