Breast Neoplasms Clinical Trial
Official title:
Detection and Analysis of Circulating Tumor Cells (CTCs) in Patients With Breast Cancer Using a Novel Microfluidic and Raman Spectrum Device
Circulating tumor cells (CTCs) in peripheral blood originate from breast cancer (primary and metastatic lesions) shedding. Utilization of CTCs as novel and noninvasive tests for diagnosis confirmation, therapy selection, and cancer surveillance is a rapidly growing area of interest. In this project, the investigators will explore a novel detection technology of circulating tumor cells in breast cancer using novel Microfluidic and Raman Spectrum Device. The primary objective is to demonstrate that the CTC assay counts technology can distinguish between healthy subjects and malignant breast cancer subjects. The secondary objective is to demonstrate that the CTCs detection technology can evaluate the efficacy of chemotherapy and neoadjuvant chemotherapy, as well as dynamic treatment monitoring and prognosis evaluation.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | December 2022 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: - All subjects need to sign the informed consent form. - Age of at least 20 and at most 70 years. - Cancer group subjects with pathology report confirmed to be malignant. - Chemotherapy is necessary before or after surgery. - Control group need to have mammogram /ultrasound results category1-3. - Patients must be available for and compliant to treatment and follow-up. Exclusion Criteria: - Not willing to sign the informed consent form. - Pregnant or lactating patients. - Prior or concomitant secondary malignancy. - Any other serious medical pathology, such as congestive heart failure. - Other condition which may affect the CTC results. - Males. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Xijing Hospital | Xidian University |
Ahmed MG, Abate MF, Song Y, Zhu Z, Yan F, Xu Y, Wang X, Li Q, Yang C. Isolation, Detection, and Antigen-Based Profiling of Circulating Tumor Cells Using a Size-Dictated Immunocapture Chip. Angew Chem Int Ed Engl. 2017 Aug 28;56(36):10681-10685. doi: 10.1002/anie.201702675. Epub 2017 Jul 26. — View Citation
Alix-Panabières C, Mader S, Pantel K. Epithelial-mesenchymal plasticity in circulating tumor cells. J Mol Med (Berl). 2017 Feb;95(2):133-142. doi: 10.1007/s00109-016-1500-6. Epub 2016 Dec 24. Review. — View Citation
Alix-Panabières C, Pantel K. Clinical Applications of Circulating Tumor Cells and Circulating Tumor DNA as Liquid Biopsy. Cancer Discov. 2016 May;6(5):479-91. doi: 10.1158/2159-8290.CD-15-1483. Epub 2016 Mar 11. Review. — View Citation
Bhuvanendran Nair Gourikutty S, Chang CP, Poenar DP. An integrated on-chip platform for negative enrichment of tumour cells. J Chromatogr B Analyt Technol Biomed Life Sci. 2016 Aug 15;1028:153-164. doi: 10.1016/j.jchromb.2016.06.016. Epub 2016 Jun 14. — View Citation
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. — View Citation
Cabel L, Proudhon C, Gortais H, Loirat D, Coussy F, Pierga JY, Bidard FC. Circulating tumor cells: clinical validity and utility. Int J Clin Oncol. 2017 Jun;22(3):421-430. doi: 10.1007/s10147-017-1105-2. Epub 2017 Feb 25. Review. — View Citation
Cai S, Shi H, Li G, Xue Q, Zhao L, Wang F, Hu B. 3D-Printed Concentration-Controlled Microfluidic Chip with Diffusion Mixing Pattern for the Synthesis of Alginate Drug Delivery Microgels. Nanomaterials (Basel). 2019 Oct 12;9(10). pii: E1451. doi: 10.3390/ — View Citation
Chen CL, Chen KC, Pan YC, Lee TP, Hsiung LC, Lin CM, Chen CY, Lin CH, Chiang BL, Wo AM. Separation and detection of rare cells in a microfluidic disk via negative selection. Lab Chip. 2011 Feb 7;11(3):474-83. doi: 10.1039/c0lc00332h. Epub 2010 Nov 18. — View Citation
Chen P, Huang YY, Bhave G, Hoshino K, Zhang X. Inkjet-Print Micromagnet Array on Glass Slides for Immunomagnetic Enrichment of Circulating Tumor Cells. Ann Biomed Eng. 2016 May;44(5):1710-20. doi: 10.1007/s10439-015-1427-z. Epub 2015 Aug 20. — View Citation
Cho H, Kim J, Song H, Sohn KY, Jeon M, Han KH. Microfluidic technologies for circulating tumor cell isolation. Analyst. 2018 Jun 25;143(13):2936-2970. doi: 10.1039/c7an01979c. Review. — View Citation
Fan L, Strasser-Weippl K, Li JJ, St Louis J, Finkelstein DM, Yu KD, Chen WQ, Shao ZM, Goss PE. Breast cancer in China. Lancet Oncol. 2014 Jun;15(7):e279-89. doi: 10.1016/S1470-2045(13)70567-9. Review. — View Citation
Harb W, Fan A, Tran T, Danila DC, Keys D, Schwartz M, Ionescu-Zanetti C. Mutational Analysis of Circulating Tumor Cells Using a Novel Microfluidic Collection Device and qPCR Assay. Transl Oncol. 2013 Oct 1;6(5):528-38. eCollection 2013. — View Citation
Hong Y, Li Z, Zhang Q. A circulating tumor cell cluster-based model for tumor metastasis (Hypothesis). Oncol Lett. 2016 Dec;12(6):4891-4895. doi: 10.3892/ol.2016.5358. Epub 2016 Nov 7. — View Citation
Jack RM, Grafton MM, Rodrigues D, Giraldez MD, Griffith C, Cieslak R, Zeinali M, Kumar Sinha C, Azizi E, Wicha M, Tewari M, Simeone DM, Nagrath S. Ultra-Specific Isolation of Circulating Tumor Cells Enables Rare-Cell RNA Profiling. Adv Sci (Weinh). 2016 Apr 18;3(9):1600063. eCollection 2016 Sep. — View Citation
Karabacak NM, Spuhler PS, Fachin F, Lim EJ, Pai V, Ozkumur E, Martel JM, Kojic N, Smith K, Chen PI, Yang J, Hwang H, Morgan B, Trautwein J, Barber TA, Stott SL, Maheswaran S, Kapur R, Haber DA, Toner M. Microfluidic, marker-free isolation of circulating tumor cells from blood samples. Nat Protoc. 2014 Mar;9(3):694-710. doi: 10.1038/nprot.2014.044. Epub 2014 Feb 27. — View Citation
Kwak B, Lee J, Lee J, Kim HS, Kang S, Lee Y. Spiral shape microfluidic channel for selective isolating of heterogenic circulating tumor cells. Biosens Bioelectron. 2018 Mar 15;101:311-316. doi: 10.1016/j.bios.2017.10.036. Epub 2017 Oct 17. — View Citation
Liu Z, Huang F, Du J, Shu W, Feng H, Xu X, Chen Y. Rapid isolation of cancer cells using microfluidic deterministic lateral displacement structure. Biomicrofluidics. 2013 Jan 7;7(1):11801. doi: 10.1063/1.4774308. eCollection 2013. — View Citation
Micalizzi DS, Maheswaran S, Haber DA. A conduit to metastasis: circulating tumor cell biology. Genes Dev. 2017 Sep 15;31(18):1827-1840. doi: 10.1101/gad.305805.117. Review. — View Citation
Mittal V. Epithelial Mesenchymal Transition in Tumor Metastasis. Annu Rev Pathol. 2018 Jan 24;13:395-412. doi: 10.1146/annurev-pathol-020117-043854. Review. — View Citation
Poudineh M, Aldridge PM, Ahmed S, Green BJ, Kermanshah L, Nguyen V, Tu C, Mohamadi RM, Nam RK, Hansen A, Sridhar SS, Finelli A, Fleshner NE, Joshua AM, Sargent EH, Kelley SO. Tracking the dynamics of circulating tumour cell phenotypes using nanoparticle-mediated magnetic ranking. Nat Nanotechnol. 2017 Mar;12(3):274-281. doi: 10.1038/nnano.2016.239. Epub 2016 Nov 21. — View Citation
Poudineh M, Labib M, Ahmed S, Nguyen LN, Kermanshah L, Mohamadi RM, Sargent EH, Kelley SO. Profiling Functional and Biochemical Phenotypes of Circulating Tumor Cells Using a Two-Dimensional Sorting Device. Angew Chem Int Ed Engl. 2017 Jan 2;56(1):163-168. doi: 10.1002/anie.201608983. Epub 2016 Nov 29. — View Citation
Renier C, Pao E, Che J, Liu HE, Lemaire CA, Matsumoto M, Triboulet M, Srivinas S, Jeffrey SS, Rettig M, Kulkarni RP, Di Carlo D, Sollier-Christen E. Label-free isolation of prostate circulating tumor cells using Vortex microfluidic technology. NPJ Precis Oncol. 2017 May 8;1(1):15. doi: 10.1038/s41698-017-0015-0. eCollection 2017. — View Citation
Riethdorf S, Fritsche H, Müller V, Rau T, Schindlbeck C, Rack B, Janni W, Coith C, Beck K, Jänicke F, Jackson S, Gornet T, Cristofanilli M, Pantel K. Detection of circulating tumor cells in peripheral blood of patients with metastatic breast cancer: a validation study of the CellSearch system. Clin Cancer Res. 2007 Feb 1;13(3):920-8. — View Citation
Satelli A, Mitra A, Brownlee Z, Xia X, Bellister S, Overman MJ, Kopetz S, Ellis LM, Meng QH, Li S. Epithelial-mesenchymal transitioned circulating tumor cells capture for detecting tumor progression. Clin Cancer Res. 2015 Feb 15;21(4):899-906. doi: 10.1158/1078-0432.CCR-14-0894. Epub 2014 Dec 16. — View Citation
Satelli A, Mitra A, Cutrera JJ, Devarie M, Xia X, Ingram DR, Dibra D, Somaiah N, Torres KE, Ravi V, Ludwig JA, Kleinerman ES, Li S. Universal marker and detection tool for human sarcoma circulating tumor cells. Cancer Res. 2014 Mar 15;74(6):1645-50. doi: 10.1158/0008-5472.CAN-13-1739. Epub 2014 Jan 21. — View Citation
Stott SL, Hsu CH, Tsukrov DI, Yu M, Miyamoto DT, Waltman BA, Rothenberg SM, Shah AM, Smas ME, Korir GK, Floyd FP Jr, Gilman AJ, Lord JB, Winokur D, Springer S, Irimia D, Nagrath S, Sequist LV, Lee RJ, Isselbacher KJ, Maheswaran S, Haber DA, Toner M. Isolation of circulating tumor cells using a microvortex-generating herringbone-chip. Proc Natl Acad Sci U S A. 2010 Oct 26;107(43):18392-7. doi: 10.1073/pnas.1012539107. Epub 2010 Oct 7. — View Citation
Sun Y, Haglund TA, Rogers AJ, Ghanim AF, Sethu P. Review: Microfluidics technologies for blood-based cancer liquid biopsies. Anal Chim Acta. 2018 Jul 5;1012:10-29. doi: 10.1016/j.aca.2017.12.050. Epub 2018 Feb 3. Review. — View Citation
Taylor-Papadimitriou J, Burchell JM, Graham R, Beatson R. Latest developments in MUC1 immunotherapy. Biochem Soc Trans. 2018 Jun 19;46(3):659-668. doi: 10.1042/BST20170400. Epub 2018 May 21. Review. — View Citation
Thege FI, Lannin TB, Saha TN, Tsai S, Kochman ML, Hollingsworth MA, Rhim AD, Kirby BJ. Microfluidic immunocapture of circulating pancreatic cells using parallel EpCAM and MUC1 capture: characterization, optimization and downstream analysis. Lab Chip. 2014 May 21;14(10):1775-84. doi: 10.1039/c4lc00041b. Epub 2014 Mar 28. — View Citation
Toss A, Mu Z, Fernandez S, Cristofanilli M. CTC enumeration and characterization: moving toward personalized medicine. Ann Transl Med. 2014 Nov;2(11):108. doi: 10.3978/j.issn.2305-5839.2014.09.06. Review. — View Citation
Waheed S, Cabot JM, Macdonald NP, Lewis T, Guijt RM, Paull B, Breadmore MC. 3D printed microfluidic devices: enablers and barriers. Lab Chip. 2016 May 24;16(11):1993-2013. doi: 10.1039/c6lc00284f. Review. — View Citation
Warkiani ME, Khoo BL, Wu L, Tay AK, Bhagat AA, Han J, Lim CT. Ultra-fast, label-free isolation of circulating tumor cells from blood using spiral microfluidics. Nat Protoc. 2016 Jan;11(1):134-48. doi: 10.1038/nprot.2016.003. Epub 2015 Dec 17. — View Citation
Wu J, Chen Q, Lin JM. Microfluidic technologies in cell isolation and analysis for biomedical applications. Analyst. 2017 Jan 26;142(3):421-441. doi: 10.1039/c6an01939k. Review. — View Citation
Xu X, Zhao L, Xue Q, Fan J, Hu Q, Tang C, Shi H, Hu B, Tian J. Dynamic Liquid Surface Enhanced Raman Scattering Platform Based on Soft Tubular Microfluidics for Label-Free Cell Detection. Anal Chem. 2019 Jul 2;91(13):7973-7979. doi: 10.1021/acs.analchem.9 — View Citation
Yin P, Hu B, Yi L, Xiao C, Cao X, Zhao L, Shi H. Engineering of Removing Sacrificial Materials in 3D-Printed Microfluidics. Micromachines (Basel). 2018 Jun 28;9(7). pii: E327. doi: 10.3390/mi9070327. — View Citation
Yuan S, Shi C, Ling R, Wang T, Wang H, Han W. Immunization with two recombinant Bacillus Calmette-Guérin vaccines that combine the expression of multiple tandem repeats of mucin-1 and colony stimulating-factor suppress breast tumor growth in mice. J Cancer Res Clin Oncol. 2010 Sep;136(9):1359-67. doi: 10.1007/s00432-010-0787-x. Epub 2010 Feb 3. — View Citation
Yuan S, Shi C, Liu L, Han W. MUC1-based recombinant Bacillus Calmette-Guerin vaccines as candidates for breast cancer immunotherapy. Expert Opin Biol Ther. 2010 Jul;10(7):1037-48. doi: 10.1517/14712598.2010.485185. Review. — View Citation
* Note: There are 37 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The level of CTC markers in breast cancer patients' peripheral blood | The counts and analysis of CTC of peripheral blood in breast cancer group and healthy control group. | 19 Months | |
Secondary | The change of CTC markers in breast cancer patients' peripheral blood during chemotherapy and Neoadjuvant chemotherapy | The counts and analysis of CTC in patients' peripheral blood during chemotherapy and Neoadjuvant chemotherapy in different periods. | 17 Months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05558917 -
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
|
N/A | |
Active, not recruiting |
NCT03664778 -
Abbreviated Breast MRI After Cancer Treatment
|
||
Recruiting |
NCT03144622 -
18F-FSPG PET/CT Imaging in Patients With Cancers
|
||
Completed |
NCT05452499 -
Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae
|
N/A | |
Active, not recruiting |
NCT04568902 -
Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
|
Phase 1 | |
Completed |
NCT02860585 -
Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
|
N/A | |
Completed |
NCT04059809 -
Photobiomodulation for Breast Cancer Radiodermatitis
|
Phase 2/Phase 3 | |
Recruiting |
NCT04557449 -
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03698942 -
Delphinus SoftVue™ ROC Reader Study
|
||
Completed |
NCT00092950 -
Exercise in Women at Risk for Breast Cancer
|
Phase 2 | |
Terminated |
NCT04123704 -
Sitravatinib in Metastatic Breast Cancer
|
Phase 2 | |
Not yet recruiting |
NCT02151071 -
The Breast Surgery EnLight and LightPath Imaging System Study
|
Phase 1/Phase 2 | |
Recruiting |
NCT02934360 -
TR(ACE) Assay Clinical Specimen Study
|
N/A | |
Active, not recruiting |
NCT02950064 -
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
|
Phase 1 | |
Completed |
NCT02931552 -
Nuevo Amanecer II: Translating a Stress Management Program for Latinas
|
N/A | |
Not yet recruiting |
NCT02876848 -
A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
|
N/A | |
Recruiting |
NCT02547545 -
Breast Cancer Chemotherapy Risk Prediction Mathematical Model
|
N/A | |
Completed |
NCT02518477 -
Preventive Intervention Against Lymphedema After Breast Cancer Surgery
|
N/A | |
Completed |
NCT02303366 -
Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475
|
Phase 1 | |
Completed |
NCT02652975 -
Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium
|
N/A |