Breast NeoplasmsNCT04239105
Detection of Circulating Tumor Cells in Breast Cancer Patients Using a Novel Microfluidic and Raman Spectrum Device
An observational study of Breast Neoplasms and Circulating Tumor Cells, run by Xijing Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms, Circulating Tumor Cells
- What is being tested?
- Microfluidic and Raman spectrum
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast cancer patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
Circulating tumor cells (CTCs) are a new type of breast cancer molecular marker. 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. At present, there is a great challenge to create an effective platform that can isolate these cells, as they are extremely rare: only 1-10 CTCs are present in a 7.5mL of a cancer patient's peripheral blood. The majority of the CTC capture methods are based on EpCAM expression as a surface marker of tumor-derived cells. However, EpCAM protein expression levels can be significantly down regulated during cancer progression as a consequence of the process of epithelial to mesenchymal transition. Although many technologies have been reported to achieve the capture and counting of CTCs, these methods study little information of cells and limited biological information can be obtained, leading to a lack in clinical diagnosis.
Microfluidics has demonstrated great potential as an effective technique for the medical and biological sciences. Inspired by the bed topography in river meanders, here, the investigators report a novel river meander-like cross-section in helical microchannels for size-based inertial focusing and enrichment, aiming to realize more functional geometries as well as reduce the extensive laborious requirement in traditional fabrication process. This device can facilitate particle focusing at a larger scale than traditional channels. Compared to the circular, rectangular and trapezoidal channels, the river meander-like microfluidic channel can successfully realize 26 μm particle focusing with a thinner focusing band in a shorter channel length. Also, in a single test, this structure can achieve 85.4% recovery and the enrichment ratio of 1.86 of spiked MDA-MB-231 cells in the whole blood, overcoming the dependence on traditional cell manipulation microfluidic devices. These results indicate that this river meander-like microfluidic chip has the great potential of size-based cell/particle sorting and enrichment for clinical application. Meanwhile, Surface-enhanced Raman scattering (SERS) has such advantages as high sensitivity, flexible excitation wavelength, high spectral resolution, non-invasiveness to biological samples, resistance self-fluorescence, photobleaching, etc., which is considered as a promising and powerful real-time detection technology for unlabeled cells. But SERS spectrum of cell contains information about different molecules, so it usually requires complex data interpretation. Therefore, the application of Raman spectroscopy combined with chemometrics in biological problems has attracted more and more attention. However, analysis result of chemometrics can be influenced by the complex background of Raman spectroscopy. Therefore, a pre-processing is needed to remove these influencing factors.
Based on these previous work, the investigators have developed a novel technology for the detection of CTCs of breast cancer. The detection platform constructed by the combination of microfluidic chip and surface-enhanced Raman spectroscopy is used to detect the blood sample of the subject, obtain the high quality of breast cancer circulating tumor cells from the aspects of cell specificity, surface structure and molecular activity of surface-enhanced Raman spectrum information, and extract the characteristics of different breast cancer circulating tumor cells by related signal feature extraction methods, establish a standard surface-enhanced Raman spectral feature database for the main types of breast cancer circulating tumor cells.
This technology aims to build a platform allowing for cell detection, synthesize particles for surface plasmon Raman enhancement, fabricate microfluidic devices, study the collection and analysis of the Raman spectra of CTCs, establish the database of CTC Raman spectra and develop the evaluation method of the biological detection. 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.
- Conditions
- Breast Neoplasms, Circulating Tumor Cells
- Being tested
- Microfluidic and Raman spectrum
- Keywords
- Breast Cancer, Circulating Tumor Cells, Microfluidic, Raman Spectrum
- Medical subject headings
- Breast Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfluidic and Raman spectrumDevice
Detection of Circulating Tumor Cells
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer Group | The biopsy result is breast cancer. Receives: Device: Microfluidic and Raman spectrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 19 Months
Secondary outcomes (1)
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.
Measured: 17 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xidian University
- Responsible party
- Principal investigator, Yuan Shifang, Xijing Hospital
- Investigators
- Shifang Yuan, Ph.D, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239105
- Sponsor's protocol ID
- Yuan Shifang-1
- Status last verified
- Jan 2020
- First submitted
- 31 Dec 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30207593Fan 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.
PubMed 24872111Hong 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.
PubMed 28105198Micalizzi 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.
PubMed 29051388Alix-Panabieres 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.
PubMed 28013389Mittal V. Epithelial Mesenchymal Transition in Tumor Metastasis. Annu Rev Pathol. 2018 Jan 24;13:395-412. doi: 10.1146/annurev-pathol-020117-043854.
PubMed 29414248Cabel 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.
PubMed 28238187Alix-Panabieres 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.
PubMed 26969689Toss 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.
PubMed 25489582Wu 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.
PubMed 27900377Cho 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.
PubMed 29796523Sun 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.
PubMed 29475470Thege 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.
PubMed 24681997Stott 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.
PubMed 20930119Riethdorf S, Fritsche H, Muller V, Rau T, Schindlbeck C, Rack B, Janni W, Coith C, Beck K, Janicke 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. doi: 10.1158/1078-0432.CCR-06-1695.
PubMed 17289886
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Analysis of Circulating Tumor Cells (CTCs) in Patients With Breast Cancer Using a Novel Microfluidic and Raman Spectrum Device
- ClinicalTrials.gov ID
- NCT04239105
- Acronym / sponsor ID
- Yuan Shifang-1
- Conditions
- Breast Neoplasms, Circulating Tumor Cells
- Keywords
- Breast Cancer, Circulating Tumor Cells, Microfluidic, Raman Spectrum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Xidian University
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Circulating tumor cells (CTCs) are a new type of breast cancer molecular marker. 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. At present, there is a great challenge to create an effective platform that can isolate these cells, as they are extremely rare: only 1-10 CTCs are present in a 7.5mL of a cancer patient's peripheral blood. The majority of the CTC capture methods are based on EpCAM expression as a surface marker of tumor-derived cells. However, EpCAM protein expression levels can be significantly down regulated during cancer progression as a consequence of the process of epithelial to mesenchymal transition. Although many technologies have been reported to achieve the capture and counting of CTCs, these methods study little information of cells and limited biological information can be obtained, leading to a lack in clinical diagnosis.
Microfluidics has demonstrated great potential as an effective technique for the medical and biological sciences. Inspired by the bed topography in river meanders, here, the investigators report a novel river meander-like cross-section in helical microchannels for size-based inertial focusing and enrichment, aiming to realize more functional geometries as well as reduce the extensive laborious requirement in traditional fabrication process. This device can facilitate particle focusing at a larger scale than traditional channels. Compared to the circular, rectangular and trapezoidal channels, the river meander-like microfluidic channel can successfully realize 26 μm particle focusing with a thinner focusing band in a shorter channel length. Also, in a single test, this structure can achieve 85.4% recovery and the enrichment ratio of 1.86 of spiked MDA-MB-231 cells in the whole blood, overcoming the dependence on traditional cell manipulation microfluidic devices. These results indicate that this river meander-like microfluidic chip has the great potential of size-based cell/particle sorting and enrichment for clinical application. Meanwhile, Surface-enhanced Raman scattering (SERS) has such advantages as high sensitivity, flexible excitation wavelength, high spectral resolution, non-invasiveness to biological samples, resistance self-fluorescence, photobleaching, etc., which is considered as a promising and powerful real-time detection technology for unlabeled cells. But SERS spectrum of cell contains information about different molecules, so it usually requires complex data interpretation. Therefore, the application of Raman spectroscopy combined with chemometrics in biological problems has attracted more and more attention. However, analysis result of chemometrics can be influenced by the complex background of Raman spectroscopy. Therefore, a pre-processing is needed to remove these influencing factors.
Based on these previous work, the investigators have developed a novel technology for the detection of CTCs of breast cancer. The detection platform constructed by the combination of microfluidic chip and surface-enhanced Raman spectroscopy is used to detect the blood sample of the subject, obtain the high quality of breast cancer circulating tumor cells from the aspects of cell specificity, surface structure and molecular activity of surface-enhanced Raman spectrum information, and extract the characteristics of different breast cancer circulating tumor cells by related signal feature extraction methods, establish a standard surface-enhanced Raman spectral feature database for the main types of breast cancer circulating tumor cells.
This technology aims to build a platform allowing for cell detection, synthesize particles for surface plasmon Raman enhancement, fabricate microfluidic devices, study the collection and analysis of the Raman spectra of CTCs, establish the database of CTC Raman spectra and develop the evaluation method of the biological detection. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer Group | – | Device: Microfluidic and Raman spectrumThe biopsy result is breast cancer. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microfluidic and Raman spectrumDetection of Circulating Tumor Cells | Device | Breast cancer Group |
Primary outcome
The level of CTC markers in breast cancer patients' peripheral blood
Time frame: 19 Months
The counts and analysis of CTC of peripheral blood in breast cancer group and healthy control group.
1 secondary outcome
The change of CTC markers in breast cancer patients' peripheral blood during chemotherapy and Neoadjuvant chemotherapy
Time frame: 17 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Background: PubMed 30207593Bray 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.
- Background: PubMed 24872111Fan 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.
- Background: PubMed 28105198Hong 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.
- Background: PubMed 29051388Micalizzi 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.
- Background: PubMed 28013389Alix-Panabieres 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.
- Background: PubMed 29414248Mittal V. Epithelial Mesenchymal Transition in Tumor Metastasis. Annu Rev Pathol. 2018 Jan 24;13:395-412. doi: 10.1146/annurev-pathol-020117-043854.
- Background: PubMed 28238187Cabel 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.
- Background: PubMed 26969689Alix-Panabieres 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.
- Background: PubMed 25489582Toss 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.
- Background: PubMed 27900377Wu 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.
- Background: PubMed 29796523Cho 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.
- Background: PubMed 29475470Sun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shifang Yuan, Ph.D principal investigator
Xijing Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Circulating Tumor Cells, run by Xijing Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shifang Yuan, professor (13991249382, shifangy@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of CTC markers in breast cancer patients' peripheral blood (time frame: 19 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04239105, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.