Cell CarcinomaNCT05623748
Establishment and Application of 3-Dimensional (3-D) Cell Culture Model of Clinical Circulating Tumor Cells (CTCs)
An observational study of Cell Carcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The goal of this observational study is to validate and evaluate the clinical feasibility of using a 3-D cell culture model for CTCs isolation/purification and their cell number expansion in cancer patient with transitional cell carcinoma and patient without cancer. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cell Carcinoma
- What is being tested?
- CTCs isolation/purification and cell number expansion
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Aug 2021to 31 Aug 2025
- How long will I take part?
- 6 Months
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: cancer patients with transitional cell carcinoma
Who may be able to join
- patients who agreed with the content of informed consent of the study protocol
- patients who agreed the researcher to review the medical record
- adults >20 years old
- Patients have the right to asked withdrawing from the trial at any timepoints
- meet the following requirements (1)cancer participants:cancer patients with transitional cell carcinoma (2)healthy participants:participants without cancer
Who cannot join
- Patients who refused the collection of blood and the reviewing of medical record
- The investigators suggest to withdraw
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to validate and evaluate the clinical feasibility of using a 3-D cell culture model for CTCs isolation/purification and their cell number expansion in cancer patient with transitional cell carcinoma and patient without cancer.
This project first aims to study the clinical feasibility of utilizing a 3-D cell culture model for the isolation/purification of all possible CTCs in a blood sample in a label-free, viable, and high-purity manner. Through 3-D CTC culture, moreover, the cell number of CTCs can be adequately expanded. All these advantageous features are beyond what is currently possible by using the existing methods. In addition, the harvest of CTCs with above features is found valuable for the subsequent academic researches or clinical studies (e.g. molecular mechanisms underlying cancer metastasis, cancer-related gene mutation, biomarker discovery, and particularly CTCs-based chemotherapy drug testing). These could both facilitate and accelerate scientists to develop new therapeutic solutions for future cancer care.
Read the detailed description
Circulating tumor cells (CTCs), the rare cell species present in the blood, are considered to mainly contribute to cancer metastasis or relapse. Thus, the detection of CTCs is regarded as an essential clinical tool to detect metastatic cancer. Moreover, CTCs can be the therapeutic target of metastatic cancer care. Therefore, the use of viable CTCs as a biopsy to select therapeutic regimens (e.g. CTCs-based anti-cancer drug testing) opens up a promising route to realize personalized cancer therapy. With the recent advances in cell isolation or detection techniques, various novel approaches have been actively proposed to isolate/detect CTCs. Nevertheless, most of current methods might not be able to obtain the all possible, viable, and label-free CTCs with adequate cell purity and cell number for the subsequent CTCs-based anti-cancer drug testing or other bioassays. To tackle the above technical hurdles, the research project proposes the use of a specific 3-D cell culture technique for the isolation/purification, and cell number expansion of CTCs.
The working principle is based on our preliminary findings showing that the human leukocytes will die away in 3-D cell culture condition, whereas the CTCs will tend to aggregate and proliferate in such environment. Based on this phenomenon, the 3-D CTC cell culture can be used to isolate and purify the viable CTCs from the leukocyte background in a negative selection, and label-free manner, enabling the harvest of the all possible CTCs in a blood sample. Furthermore, the proliferation of CTCs in such 3-D cell culture can adequately expand the cell number of CTCs for the subsequent applications, which is currently impossible using the existing methods.
In the 1st year research project, investigators will further validate and evaluate the clinical feasibility of using a 3-D cell culture model for CTCs isolation/purification and their cell number expansion. In the 2nd and 3rd year research project, investigators will optimize the 3-D cell culture model so as to increase the performances of CTC isolation/purification and proliferation. In the optimization process, investigators will explore the effect of cell culture model (e.g. static or perfusion cell culture, and 3-D cell culture using different 3-D scaffolding materials) or biochemical factors (e.g. glucose concentration, serum concentration, pH, or the supplements of growth factors/cytokines) on the the performances of CTC solation/purification and proliferation. As a whole, investigators hope the proposed research project can find out an efficient and effective approach to isolate/purify/expand clinical CTCs in a viable, label-free, and high-purity manner. These harvested CTCs are valuable for the subsequent analytical tasks.
- Conditions
- Cell Carcinoma
- Being tested
- CTCs isolation/purification and cell number expansion
- Keywords
- CTCs, 3-D Cell culture, Cell purification, Cell proliferation
- Medical subject headings
- Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTCs isolation/purification and cell number expansionProcedure or surgery
In the 1st year research project, investigators will further validate and evaluate the clinical feasibility of using a 3-D cell culture model for CTCs isolation/purification and their cell number expansion. In the 2nd and 3rd year research project, investigators will optimize the 3-D cell culture model so as to increase the performances of CTC isolation/purification and proliferation. In the optimization process, investigators will explore the effect of cell culture model (e.g. static or perfusion cell culture, and 3-D cell culture using different 3-D scaffolding materials) or biochemical factors (e.g. glucose concentration, serum concentration, pH, or the supplements of growth factors/cytokines) on the the performances of CTC isolation/purification and proliferation.
| Study group | Role | What they receive |
|---|---|---|
| Cancer for CTC culture | participants are cancer patients with transitional cell carcinoma Receives: Procedure: CTCs isolation/purification and cell number expansion | |
| Healthy for CTC culture | enroll participants without cancer Receives: Procedure: CTCs isolation/purification and cell number expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of cell culture model for the Cell viability
optimize the 3-D cell culture model to measure the Cell viability
Measured: baseline
the effect of cell culture model for the Cell viability
optimize the 3-D cell culture model to measure the Cell viability
Measured: 3 month
the effect of cell culture model for the Cell viability
optimize the 3-D cell culture model to measure the Cell viability
Measured: 6 month
the effect of cell culture model for the Cell number
optimize the 3-D cell culture model to measure the Cell number
Measured: baseline
the effect of cell culture model for the Cell number
optimize the 3-D cell culture model to measure the Cell number
Measured: 3 month
the effect of cell culture model for the Cell number
optimize the 3-D cell culture model to measure the Cell number
Measured: 6 month
Secondary outcomes (9)
the effect of biochemical factors for glucose concentration
investigate the effect of of biochemical factors to measure glucose concentration
Measured: baseline, pre-intervention
the effect of biochemical factors for glucose concentration
investigate the effect of of biochemical factors to measure glucose concentration
Measured: 3 month
the effect of biochemical factors for glucose concentration
investigate the effect of of biochemical factors to measure glucose concentration
Measured: 6 month
the effect of biochemical factors for the serum concentration of growth factors/cytokines
investigate the effect of of biochemical factors to measure the serum concentration of growth factors/cytokines
Measured: baseline, pre-intervention
the effect of biochemical factors for the serum concentration of growth factors/cytokines
investigate the effect of of biochemical factors to measure the serum concentration of growth factors/cytokines
Measured: 3 month
the effect of biochemical factors for the serum concentration of growth factors/cytokines
investigate the effect of of biochemical factors to measure the serum concentration of growth factors/cytokines
Measured: 6 month
the effect of biochemical factors for the serum pH
investigate the effect of of biochemical factors to measure the serum pH
Measured: baseline
the effect of biochemical factors for the serum pH
investigate the effect of of biochemical factors to measure the serum pH
Measured: 3 month
the effect of biochemical factors for the serum pH
investigate the effect of of biochemical factors to measure the serum pH
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start31 Aug 2021
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsuan-Chih Kuo, Study director, Ye,Siou-Ru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623748
- Sponsor's protocol ID
- 202101222A3
- Status last verified
- Sep 2025
- First submitted
- 7 Nov 2022
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oppenheimer SB. Cellular basis of cancer metastasis: A review of fundamentals and new advances. Acta Histochem. 2006;108(5):327-34. doi: 10.1016/j.acthis.2006.03.008. Epub 2006 May 26.
PubMed 16730054Mehlen P, Puisieux A. Metastasis: a question of life or death. Nat Rev Cancer. 2006 Jun;6(6):449-58. doi: 10.1038/nrc1886.
PubMed 16723991Konstantopoulos K, Thomas SN. Cancer cells in transit: the vascular interactions of tumor cells. Annu Rev Biomed Eng. 2009;11:177-202. doi: 10.1146/annurev-bioeng-061008-124949.
PubMed 19413512
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Application of 3-Dimensional (3-D) Cell Culture Model of Clinical Circulating Tumor Cells (CTCs)
- ClinicalTrials.gov ID
- NCT05623748
- Acronym / sponsor ID
- 202101222A3
- Conditions
- Cell Carcinoma
- Keywords
- CTCs, 3-D Cell culture, Cell purification, Cell proliferation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 21 Nov 2022 (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.
The goal of this observational study is to validate and evaluate the clinical feasibility of using a 3-D cell culture model for CTCs isolation/purification and their cell number expansion in cancer patient with transitional cell carcinoma and patient without cancer.
This project first aims to study the clinical feasibility of utilizing a 3-D cell culture model for the isolation/purification of all possible CTCs in a blood sample in a label-free, viable, and high-purity manner. Through 3-D CTC culture, moreover, the cell number of CTCs can be adequately expanded. All these advantageous features are beyond what is currently possible by using the existing methods. In addition, the harvest of CTCs with above features is found valuable for the subsequent academic researches or clinical studies (e.g. molecular mechanisms underlying cancer metastasis, cancer-related gene mutation, biomarker discovery, and particularly CTCs-based chemotherapy drug testing). These could both facilitate and accelerate scientists to develop new therapeutic solutions for future cancer care.
Detailed description
Circulating tumor cells (CTCs), the rare cell species present in the blood, are considered to mainly contribute to cancer metastasis or relapse. Thus, the detection of CTCs is regarded as an essential clinical tool to detect metastatic cancer. Moreover, CTCs can be the therapeutic target of metastatic cancer care. Therefore, the use of viable CTCs as a biopsy to select therapeutic regimens (e.g. CTCs-based anti-cancer drug testing) opens up a promising route to realize personalized cancer therapy. With the recent advances in cell isolation or detection techniques, various novel approaches have been actively proposed to isolate/detect CTCs. Nevertheless, most of current methods might not be able to obtain the all possible, viable, and label-free CTCs with adequate cell purity and cell number for the subsequent CTCs-based anti-cancer drug testing or other bioassays. To tackle the above technical hurdles, the research project proposes the use of a specific 3-D cell culture technique for the isolation/purification, and cell number expansion of CTCs.
The working principle is based on our preliminary findings showing that the human leukocytes will die away in 3-D cell culture condition, whereas the CTCs will tend to aggregate and proliferate in such environment. Based on this phenomenon, the 3-D CTC cell culture can be used to isolate and purify the viable CTCs from the leukocyte background in a negative selection, and label-free manner, enabling the harvest of the all possible CTCs in a blood sample. Furthermore, the proliferation of CTCs in such 3-D cell culture can adequately expand the cell number of CTCs for the subsequent applications, which is currently impossible using the existing methods.
In the 1st year research project, investigators will further validate and evaluate the clinical feasibility of using a 3-D cell culture model for CTCs isolation/purification and their cell number expansion. In the 2nd and 3rd year research project, investigators will optimize the 3-D cell culture model so as to increase the performances of CTC isolation/purification and proliferation. In the optimization process, investigators will explore the effect of cell culture model (e.g. static or perfusion cell culture, and 3-D cell culture using different 3-D scaffolding materials) or biochemical factors (e.g. glucose concentration, serum concentration, pH, or the supplements of growth factors/cytokines) on the the performances of CTC solation/purification and proliferation. As a whole, investigators hope the proposed research project can find out an efficient and effective approach to isolate/purify/expand clinical CTCs in a viable, label-free, and high-purity manner. These harvested CTCs are valuable for the subsequent analytical tasks.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer for CTC culture | – | Procedure: CTCs isolation/purification and cell number expansionparticipants are cancer patients with transitional cell carcinoma |
| Healthy for CTC culture | – | Procedure: CTCs isolation/purification and cell number expansionenroll participants without cancer |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- cancer patients with transitional cell carcinoma
Key inclusion criteria (5 listed)
- patients who agreed with the content of informed consent of the study protocol
- patients who agreed the researcher to review the medical record
- adults >20 years old
- Patients have the right to asked withdrawing from the trial at any timepoints
- meet the following requirements (1)cancer participants:cancer patients with transitional cell carcinoma (2)healthy participants:participants without cancer
Key exclusion criteria (2 listed)
- Patients who refused the collection of blood and the reviewing of medical record
- The investigators suggest to withdraw
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 |
|---|---|---|
| CTCs isolation/purification and cell number expansionIn the 1st year research project, investigators will further validate and evaluate the clinical feasibility of using a 3-D cell culture model for CTCs isolation/purification and their cell number expansion. In the 2nd and 3rd year research project, investigators will optimize the 3-D cell culture model so as to increase the performances of CTC isolation/purification and proliferation. In the optimization process, investigators will explore the effect of cell culture model (e.g. static or perfusion cell culture, and 3-D cell culture using different 3-D scaffolding materials) or biochemical factors (e.g. glucose concentration, serum concentration, pH, or the supplements of growth factors/cytokines) on the the performances of CTC isolation/purification and proliferation. | Procedure or surgery | Cancer for CTC culture, Healthy for CTC culture |
Primary outcome
the effect of cell culture model for the Cell viability
Time frame: baseline
optimize the 3-D cell culture model to measure the Cell viability
the effect of cell culture model for the Cell viability
Time frame: 3 month
optimize the 3-D cell culture model to measure the Cell viability
the effect of cell culture model for the Cell viability
Time frame: 6 month
optimize the 3-D cell culture model to measure the Cell viability
the effect of cell culture model for the Cell number
Time frame: baseline
optimize the 3-D cell culture model to measure the Cell number
the effect of cell culture model for the Cell number
Time frame: 3 month
optimize the 3-D cell culture model to measure the Cell number
the effect of cell culture model for the Cell number
Time frame: 6 month
optimize the 3-D cell culture model to measure the Cell number
9 secondary outcomes
the effect of biochemical factors for glucose concentration
Time frame: baseline, pre-intervention
the effect of biochemical factors for glucose concentration
Time frame: 3 month
the effect of biochemical factors for glucose concentration
Time frame: 6 month
the effect of biochemical factors for the serum concentration of growth factors/cytokines
Time frame: baseline, pre-intervention
the effect of biochemical factors for the serum concentration of growth factors/cytokines
Time frame: 3 month
the effect of biochemical factors for the serum concentration of growth factors/cytokines
Time frame: 6 month
the effect of biochemical factors for the serum pH
Time frame: baseline
the effect of biochemical factors for the serum pH
Time frame: 3 month
the effect of biochemical factors for the serum pH
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Background: PubMed 16730054Oppenheimer SB. Cellular basis of cancer metastasis: A review of fundamentals and new advances. Acta Histochem. 2006;108(5):327-34. doi: 10.1016/j.acthis.2006.03.008. Epub 2006 May 26.
- Background: PubMed 16723991Mehlen P, Puisieux A. Metastasis: a question of life or death. Nat Rev Cancer. 2006 Jun;6(6):449-58. doi: 10.1038/nrc1886.
- Background: PubMed 19413512Konstantopoulos K, Thomas SN. Cancer cells in transit: the vascular interactions of tumor cells. Annu Rev Biomed Eng. 2009;11:177-202. doi: 10.1146/annurev-bioeng-061008-124949.
- Cancer is a generic term for a large group of diseases that can affect any part of the body. Other terms used are malignant tumours and neoplasms.Link provided by the sponsor.
- 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.
Hsuan-Chih Kuo study director
Ye,Siou-Ru
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cell Carcinoma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of cell culture model for the Cell viability (time frame: baseline). The study lists 6 primary outcomes in all. 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 NCT05623748, which also lists 3 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 24 Sep 2025.