microRNA of Human Epidermal Growth Factor Receptor 2 （HER2）Positive Patient Treated With Herceptin
12 de outubro de 2016 atualizado por: Erwei Song, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
A Perspective Study of the Predictive Value of microRNA in Patients With HER2 Positive Advanced Stage Breast Cancer Who Were Treated With Herceptin
This projective observational study is planned to enroll more than 300 advanced breast cancer patients, who were proved as Her-2 positive using fluorescence in situ hybridization (FISH) and / or immunohistochemistry, and 100 healthy donors as control.
Before treatment, the plasma microRNA will be collected and detected by microRNA extraction kit and quantitative polymerase chain reaction (qPCR), respectively.
After analyzed their microRNA expression by microRNA predictive model, previously reported by our team, all of enrolled patients will be classified as "probable sensitive group" or "probable resistant group".
Herceptin combined with other chemotherapy will be the backbone of salvage treatment and used for at least 3 months; the change of local masses and metastasis lesions after treatment will be documented to evaluate the response.
Based on these results, investigator aim to construct a mathematical predictive model by analyzing the correlation of baseline microRNA expression level and the prognosis of patients.
And a diagnosis microRNA kit will be planned and manufactured
Visão geral do estudo
Status
Desconhecido
Condições
Intervenção / Tratamento
Tipo de estudo
Observacional
Inscrição (Antecipado)
300
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Recrutamento
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Método de amostragem
Amostra Não Probabilística
População do estudo
advanced breast cancer patients first diagnosis in Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
Informed consent must be obtained for all of the included patients.
Descrição
Inclusion Criteria:
- The patients signed the written informed consent
- female patient who is ≥ 18yrs,
- HER2 positive: immunohistochemistry (+++) or FISH (+)
- stage IV
- the patients have no history of chemotherapy ,hormone therapy,radiotherapy or surgery after diagnosis of breast cancer
- the result of patients' blood tests are as follow: WBC≥3.0×109/L; Plt≥100×109/L;AST/SGOT or ALT/AGPT≤tripple of normal upper limit; Creatinine<double of the normal upper limit
- ECOG scores are 0 or 1 .
- The patient is able to take oral pills
Exclusion Criteria:
- The patient was never exposed to herceptin.
- The patient suffered from other non-breast malignancy in the last 5 years, except for cervical carcinoma in situ, radical basal cell carcinoma or squamous cell carcinoma.
- The life expectancy is less than 3 months.
- Severe hepatic function disorder, Child Pugh grade C.
- Severe cardiac function disorder, cardiac function is more than grade III;
- Prolonged QT interval;
- Arrhythmia or taking anti-arrhythmia drugs;
- Pregnant or breast feeding female.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Herceptin probable sensitive group
Plasma microRNAs will be collected using microRNA extraction kit according to manufacturer's instructions; and their expression levels are analyzed by quantitative polymerase chain reaction (qPCR).According to microRNAs - herceptin predictive model(reported by our team), the patients will be considered as Herceptin probable sensitive group
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Capecitabine will be administered orally at a dose of 2500mg/m2 daily for 3 months (Day 1 to 14 of a 21-day cycle)
Outros nomes:
patients will receive herceptin intravenous infusion at a dose of 6mg on day 1 of each cycle
Outros nomes:
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Herceptin probable resistant group
Plasma microRNAs will be collected using microRNA extraction kit according to manufacturer's instructions; and their expression levels are analyzed by quantitative polymerase chain reaction (qPCR).According to microRNAs - herceptin predictive model(reported by our team), the patients will be considered as Herceptin probable resistant group
|
Capecitabine will be administered orally at a dose of 2500mg/m2 daily for 3 months (Day 1 to 14 of a 21-day cycle)
Outros nomes:
patients will receive herceptin intravenous infusion at a dose of 6mg on day 1 of each cycle
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Progress-free survival of patients
Prazo: progression free survival (PFS) was defined as the interval from the diagnosis of advanced breast cancer with HER2 positive to disease progression, relapse, death due to any causes or last follow-up.The follow-up interval is 2 years.
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progression free survival (PFS) was defined as the interval from the diagnosis of advanced breast cancer with HER2 positive to disease progression, relapse, death due to any causes or last follow-up.The follow-up interval is 2 years.
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overall survival of patients
Prazo: Overall survival was defined as the interval from the diagnosis of advanced breast cancer with HER2 positive to death due to any causes or last follow-up,The follow-up interval is 2 years.
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Overall survival was defined as the interval from the diagnosis of advanced breast cancer with HER2 positive to death due to any causes or last follow-up,The follow-up interval is 2 years.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Investigadores
- Cadeira de estudo: Erwei Song, Ph.D, Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Hur K, Toiyama Y, Schetter AJ, Okugawa Y, Harris CC, Boland CR, Goel A. Identification of a metastasis-specific MicroRNA signature in human colorectal cancer. J Natl Cancer Inst. 2015 Feb 6;107(3):dju492. doi: 10.1093/jnci/dju492. Print 2015 Mar.
- Jiang L, Cheng Q, Zhang BH, Zhang MZ. Circulating microRNAs as biomarkers in hepatocellular carcinoma screening: a validation set from China. Medicine (Baltimore). 2015 Mar;94(10):e603. doi: 10.1097/MD.0000000000000603.
- Kleivi Sahlberg K, Bottai G, Naume B, Burwinkel B, Calin GA, Borresen-Dale AL, Santarpia L. A serum microRNA signature predicts tumor relapse and survival in triple-negative breast cancer patients. Clin Cancer Res. 2015 Mar 1;21(5):1207-14. doi: 10.1158/1078-0432.CCR-14-2011. Epub 2014 Dec 29.
- Xiang M, Zeng Y, Yang R, Xu H, Chen Z, Zhong J, Xie H, Xu Y, Zeng X. U6 is not a suitable endogenous control for the quantification of circulating microRNAs. Biochem Biophys Res Commun. 2014 Nov 7;454(1):210-4. doi: 10.1016/j.bbrc.2014.10.064. Epub 2014 Oct 18.
- Zhai R, Wei Y, Su L, Liu G, Kulke MH, Wain JC, Christiani DC. Whole-miRNome profiling identifies prognostic serum miRNAs in esophageal adenocarcinoma: the influence of Helicobacter pylori infection status. Carcinogenesis. 2015 Jan;36(1):87-93. doi: 10.1093/carcin/bgu228. Epub 2014 Nov 8.
- Gururajan M, Josson S, Chu GC, Lu CL, Lu YT, Haga CL, Zhau HE, Liu C, Lichterman J, Duan P, Posadas EM, Chung LW. miR-154* and miR-379 in the DLK1-DIO3 microRNA mega-cluster regulate epithelial to mesenchymal transition and bone metastasis of prostate cancer. Clin Cancer Res. 2014 Dec 15;20(24):6559-69. doi: 10.1158/1078-0432.CCR-14-1784. Epub 2014 Oct 16.
- Parpart S, Roessler S, Dong F, Rao V, Takai A, Ji J, Qin LX, Ye QH, Jia HL, Tang ZY, Wang XW. Modulation of miR-29 expression by alpha-fetoprotein is linked to the hepatocellular carcinoma epigenome. Hepatology. 2014 Sep;60(3):872-83. doi: 10.1002/hep.27200. Epub 2014 Jul 25.
- Masuda S, Izpisua Belmonte JC. Re: Serum miR-21 as a diagnostic and prognostic biomarker in colorectal cancer. J Natl Cancer Inst. 2014 Mar;106(3):djt457. doi: 10.1093/jnci/djt457. Epub 2014 Mar 1. No abstract available.
- Schwarzenbach H, Nishida N, Calin GA, Pantel K. Clinical relevance of circulating cell-free microRNAs in cancer. Nat Rev Clin Oncol. 2014 Mar;11(3):145-56. doi: 10.1038/nrclinonc.2014.5. Epub 2014 Feb 4.
- Chan M, Liaw CS, Ji SM, Tan HH, Wong CY, Thike AA, Tan PH, Ho GH, Lee AS. Identification of circulating microRNA signatures for breast cancer detection. Clin Cancer Res. 2013 Aug 15;19(16):4477-87. doi: 10.1158/1078-0432.CCR-12-3401. Epub 2013 Jun 24.
- Wang Y, Gu J, Roth JA, Hildebrandt MA, Lippman SM, Ye Y, Minna JD, Wu X. Pathway-based serum microRNA profiling and survival in patients with advanced stage non-small cell lung cancer. Cancer Res. 2013 Aug 1;73(15):4801-9. doi: 10.1158/0008-5472.CAN-12-3273. Epub 2013 Jun 17.
- Li A, Yu J, Kim H, Wolfgang CL, Canto MI, Hruban RH, Goggins M. Serum miR-1290 as a marker of pancreatic cancer--response. Clin Cancer Res. 2013 Sep 15;19(18):5252-3. doi: 10.1158/1078-0432.CCR-13-1899. Epub 2013 Jul 23. No abstract available.
- van Schooneveld E, Wouters MC, Van der Auwera I, Peeters DJ, Wildiers H, Van Dam PA, Vergote I, Vermeulen PB, Dirix LY, Van Laere SJ. Expression profiling of cancerous and normal breast tissues identifies microRNAs that are differentially expressed in serum from patients with (metastatic) breast cancer and healthy volunteers. Breast Cancer Res. 2012 Feb 21;14(1):R34. doi: 10.1186/bcr3127.
- Jackson DB. Serum-based microRNAs: are we blinded by potential? Proc Natl Acad Sci U S A. 2009 Jan 6;106(1):E5. doi: 10.1073/pnas.0809999106. Epub 2008 Dec 23. No abstract available.
- Roth C, Rack B, Muller V, Janni W, Pantel K, Schwarzenbach H. Circulating microRNAs as blood-based markers for patients with primary and metastatic breast cancer. Breast Cancer Res. 2010;12(6):R90. doi: 10.1186/bcr2766. Epub 2010 Nov 3.
- Li LM, Hu ZB, Zhou ZX, Chen X, Liu FY, Zhang JF, Shen HB, Zhang CY, Zen K. Serum microRNA profiles serve as novel biomarkers for HBV infection and diagnosis of HBV-positive hepatocarcinoma. Cancer Res. 2010 Dec 1;70(23):9798-807. doi: 10.1158/0008-5472.CAN-10-1001. Epub 2010 Nov 23. Erratum In: Cancer Res. 2011 Mar 1;71(5):2022.
- Li J, Wang Y, Yu W, Chen J, Luo J. Expression of serum miR-221 in human hepatocellular carcinoma and its prognostic significance. Biochem Biophys Res Commun. 2011 Mar 4;406(1):70-3. doi: 10.1016/j.bbrc.2011.01.111. Epub 2011 Feb 3.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de junho de 2015
Conclusão Primária (Antecipado)
1 de junho de 2018
Conclusão do estudo (Antecipado)
1 de junho de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
8 de janeiro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de janeiro de 2016
Primeira postagem (Estimativa)
15 de janeiro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
13 de outubro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de outubro de 2016
Última verificação
1 de outubro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SSC201512
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