CancerCTCNCT01022723
Clinical Validation of a Microfluidic Device for Isolation and Molecular Characterization of Circulating Tumor Cells
An observational study of Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
To evaluate the efficiency of a microdevice for circulating tumor cells isolation and to correlate the circulating titre with response and progression. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- How many people
- 817 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2009to Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with the following cancers: Lung Cancer Nasopharyneal carcinoma Breast cancer Prostate cancer Colorectal cancer Gastric cancer
Who may be able to join
- Patients with newly diagnosed metastatic disease planned for palliative chemotherapy
- Tumor types as specified: non smokers with lung adenocarcinoma, undifferentiated EBV-ISH positive nasopharyneal carcinoma, breast cancer, colorectal cancer, prostate cancer, gastric cancer
- Informed consent given for the purposes of blood sampling for this study
- Measurable disease by RECIST criteria of at least 1cm is preferred but not a sine qua non for study accrual
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre
Singapore
Lim W Teck, Medical
About this study
To evaluate the efficiency of a microdevice for circulating tumor cells isolation and to correlate the circulating titre with response and progression.
Read the detailed description
- Validate the clinical use of a mircofluidic device to capture circulating timor cells from a broad range of tumor types
- Characterize and identify these circulating tumor cells and demostrate cell viability with this capture method
- Apply this technology in clinically relevant settings and correlate to response to treatment and disease progression
- Elucidate predictive and pharmacodynamic biomarkers in the context of early phase trials of novel therapeutics
- Conditions
- Cancer
- Keywords
- Circulating tumor cells, metastasis, cancer, cell isolation, mircofludics, cell detection
- Medical subject headings
- Neoplasms, Neoplastic Cells, Circulating, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lung Cancer patients | Lung Cancer (particular focus on non smokers with adenocarcinoma) | |
| Patients with Nasopharyneal carcinoma | Patients with Nasopharyneal carcinoma | |
| Breast Cancer patients | Breast cancer patients | |
| Prostate Cancer patients | Prostate cancer patients | |
| Colorectal Cancer patients | Colorectal cancer patients | |
| Gastric Cancer patients | Gastric cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The validation of the clinical use of a microfluidic device to capture circulating tumor cells (CTC) from a broad range of tumor types
Measured: 3 years
Secondary outcomes (3)
Characteristics and viability of the CTC with this capture method
Measured: 3 years
Clinical application of this capture method with the study of CTC titre correlation to treatment outcome
Measured: 6 years
Study of predictive and pharmacodynamic biomarkers of the CTC in the context of early phase trials of novel therapeutics
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 817 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore, National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Wan-Teck Lim, MD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022723
- Sponsor's protocol ID
- CTC_ver2_081109
- Acronym
- CTC
- Status last verified
- Sep 2018
- First submitted
- 30 Nov 2009
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a Microfluidic Device for Isolation and Molecular Characterization of Circulating Tumor Cells
- ClinicalTrials.gov ID
- NCT01022723
- Acronym / sponsor ID
- CTC / CTC_ver2_081109
- Conditions
- Cancer
- Keywords
- Circulating tumor cells, metastasis, cancer, cell isolation, mircofludics, cell detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 817 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore, National University of Singapore
- Study start
- Oct 2009
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Dec 2009 (estimated)
- 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.
To evaluate the efficiency of a microdevice for circulating tumor cells isolation and to correlate the circulating titre with response and progression.
Detailed description
- Validate the clinical use of a mircofluidic device to capture circulating timor cells from a broad range of tumor types
- Characterize and identify these circulating tumor cells and demostrate cell viability with this capture method
- Apply this technology in clinically relevant settings and correlate to response to treatment and disease progression
- Elucidate predictive and pharmacodynamic biomarkers in the context of early phase trials of novel therapeutics
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer patients | – | –Lung Cancer (particular focus on non smokers with adenocarcinoma) |
| Patients with Nasopharyneal carcinoma | – | –Patients with Nasopharyneal carcinoma |
| Breast Cancer patients | – | –Breast cancer patients |
| Prostate Cancer patients | – | –Prostate cancer patients |
| Colorectal Cancer patients | – | –Colorectal cancer patients |
| Gastric Cancer patients | – | –Gastric cancer patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with the following cancers: Lung Cancer Nasopharyneal carcinoma Breast cancer Prostate cancer Colorectal cancer Gastric cancer
Key inclusion criteria (4 listed)
- Patients with newly diagnosed metastatic disease planned for palliative chemotherapy
- Tumor types as specified: non smokers with lung adenocarcinoma, undifferentiated EBV-ISH positive nasopharyneal carcinoma, breast cancer, colorectal cancer, prostate cancer, gastric cancer
- Informed consent given for the purposes of blood sampling for this study
- Measurable disease by RECIST criteria of at least 1cm is preferred but not a sine qua non for study accrual
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The validation of the clinical use of a microfluidic device to capture circulating tumor cells (CTC) from a broad range of tumor types
Time frame: 3 years
3 secondary outcomes
Characteristics and viability of the CTC with this capture method
Time frame: 3 years
Clinical application of this capture method with the study of CTC titre correlation to treatment outcome
Time frame: 6 years
Study of predictive and pharmacodynamic biomarkers of the CTC in the context of early phase trials of novel therapeutics
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
Related trials for Cancer
Not yet recruiting
Using e-Technologies to Maximize Physical Activity After Cancer Treatment
Cancer
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Pharmacogenetic Determinants Of Treatment Response In Children
All Malignancies, Children Being Treated for Catastrophic Illness
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
Wan-Teck Lim, MD principal investigator
National Cancer Centre, Singapore
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 Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 4 inclusion and 1 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 14 Sep 2018. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lanying Wang, Primary (+6564368267, nctwly@nccs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The validation of the clinical use of a microfluidic device to capture circulating tumor cells (CTC) from a broad range of tumor types (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2018.