Colo-rectal CancerNCT03476122
Clinical Application of an Automated Liquid Biopsy Platform for Early Detection of Colorectal Cancer
An observational study of Colo-rectal Cancer, run by CellMaxLife at 1 site in Taiwan.
Trial summary
Colorectal cancer (CRC) is among the most preventable cancers when precancerous lesions are detected at an early stage. Current screening methods for CRC require bowel prep or stool-based testing that are inconvenient, resulting in low compliance. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colo-rectal Cancer
- How many people
- 750 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Mar 2018to 13 Mar 2021
- 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: Colorectal cancer patients
Who may be able to join
- 1. The disease group is diagnosed with colorectal cancer 0-4 and has not been treated.
- 2. The control group will receive Colonoscopy
- 3. Above 20 years old
Who cannot join
- 1. Refuse to sign the informed consent form
- 2. Received surgery within one month
- 3. Previous cancer history
- 4. Autoimmune diseases
- 5. Chronic inflammatory diseases
- 6. Acute inflammatory or infectious diseases in three months
- 7. Myelodysplastic syndromes and myeloproliferative disorder
- 8. Other diseases decided by PI
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan City
Wen Sy Tsai, +886-3-381200 ext. 2101
About this study
Official title: Application of an Automated Liquid Biopsy System in the Detection of Colorectal Cancer
Colorectal cancer (CRC) is among the most preventable cancers when precancerous lesions are detected at an early stage. Current screening methods for CRC require bowel prep or stool-based testing that are inconvenient, resulting in low compliance. Stool based tests have limited sensitivity for the detection of precancerous lesions.
The CMx platform has been showed to be able to the detection of Circulating Tumor Cells (CTCs) in high sensitivity and specificity. In published studies, circulating Tumor Cells (CTCs) are captured and quantified in advanced-stages of colorectal cancer. In order to detect early and pre-cancer circulating tumor cells, we have developed an Automated Liquid Biopsy Platform that improves the detection of CTCs in early cancer stages. Therefore, this study goals are: 1) to establish a standard detection process utilizing the Automated Liquid Biopsy Platform. 2) Parallel comparison of laboratory manual operation and Automated Liquid Biopsy Platform. 3) Verify the feasibility of use of an Automated Liquid Biopsy Platform in the clinical setting.
Read the detailed description
- Selection of patients:
- The disease group includes 300 patients diagnosed with stages 0-4 colorectal cancer not previously treated.
- The control group includes 450 control subjects who will undergo a colonoscopy procedure.
- Study stages Stage I: The laboratory manually analyzes circulating tumor cells to establish a standard detection process for Automated Liquid Biopsy System Stage II: Comparison analysis between manual and Automated Liquid Biopsy Platform, establishing the procedural and analytical models for the Automated Liquid Biopsy Platform Stage III: Verification of the feasibility of use of an Automated Liquid Biopsy Platform in the clinical setting.
- Methods
- CTC isolation Peripheral blood drawn from subjects will be processed using the CMx platform or the automated liquid biopsy system for detection and capture.
II. Characterization of isolated CTC using Immunofluorescence Staining
III. CRC-related gene expression The serum and circulating tumor cells isolated from the blood will be used to extract RNA, and then be analyzed with the expression of different genes by real-time quantitative polymerase chain reaction (real-time PCR).
- Conditions
- Colo-rectal Cancer
- Keywords
- Colorectal cancer, CRC, Circulating tumor cells, CTCs, Early detection, Automated
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms, Neoplastic Cells, Circulating
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 |
|---|---|---|
| Disease Group | The disease group is diagnosed with colorectal cancer 0-4 and has not been treated. | |
| Control Group | The control group will receive Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of circulating tumor cells
Measured: Prior to treatment or colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start15 Mar 2018
- Primary completion1 Jan 2019 (estimated)
- Study completion13 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal 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
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CellMaxLife
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wen-Sy Tsai, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476122
- Sponsor's protocol ID
- CMx-CTC-CRC-001
- Status last verified
- Mar 2018
- First submitted
- 14 Mar 2018
- Last updated
- 2 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of an Automated Liquid Biopsy System in the Detection of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03476122
- Acronym / sponsor ID
- CMx-CTC-CRC-001
- Conditions
- Colo-rectal Cancer
- Keywords
- Colorectal cancer, CRC, Circulating tumor cells, CTCs, Early detection, Automated
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- CellMaxLifeIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 13 Mar 2021 (estimated)
- First posted
- 23 Mar 2018 (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.
Colorectal cancer (CRC) is among the most preventable cancers when precancerous lesions are detected at an early stage. Current screening methods for CRC require bowel prep or stool-based testing that are inconvenient, resulting in low compliance. Stool based tests have limited sensitivity for the detection of precancerous lesions.
The CMx platform has been showed to be able to the detection of Circulating Tumor Cells (CTCs) in high sensitivity and specificity. In published studies, circulating Tumor Cells (CTCs) are captured and quantified in advanced-stages of colorectal cancer. In order to detect early and pre-cancer circulating tumor cells, we have developed an Automated Liquid Biopsy Platform that improves the detection of CTCs in early cancer stages. Therefore, this study goals are: 1) to establish a standard detection process utilizing the Automated Liquid Biopsy Platform. 2) Parallel comparison of laboratory manual operation and Automated Liquid Biopsy Platform. 3) Verify the feasibility of use of an Automated Liquid Biopsy Platform in the clinical setting.
Detailed description
- Selection of patients:
- The disease group includes 300 patients diagnosed with stages 0-4 colorectal cancer not previously treated.
- The control group includes 450 control subjects who will undergo a colonoscopy procedure.
- Study stages Stage I: The laboratory manually analyzes circulating tumor cells to establish a standard detection process for Automated Liquid Biopsy System Stage II: Comparison analysis between manual and Automated Liquid Biopsy Platform, establishing the procedural and analytical models for the Automated Liquid Biopsy Platform Stage III: Verification of the feasibility of use of an Automated Liquid Biopsy Platform in the clinical setting.
- Methods
- CTC isolation Peripheral blood drawn from subjects will be processed using the CMx platform or the automated liquid biopsy system for detection and capture.
II. Characterization of isolated CTC using Immunofluorescence Staining
III. CRC-related gene expression The serum and circulating tumor cells isolated from the blood will be used to extract RNA, and then be analyzed with the expression of different genes by real-time quantitative polymerase chain reaction (real-time PCR).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disease Group | – | –The disease group is diagnosed with colorectal cancer 0-4 and has not been treated. |
| Control Group | – | –The control group will receive Colonoscopy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal cancer patients
Key inclusion criteria (3 listed)
- 1. The disease group is diagnosed with colorectal cancer 0-4 and has not been treated.
- 2. The control group will receive Colonoscopy
- 3. Above 20 years old
Key exclusion criteria (8 listed)
- 1. Refuse to sign the informed consent form
- 2. Received surgery within one month
- 3. Previous cancer history
- 4. Autoimmune diseases
- 5. Chronic inflammatory diseases
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
Detection of circulating tumor cells
Time frame: Prior to treatment or colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
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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.
Wen-Sy Tsai principal investigator
Chang Gung Memorial Hospital
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 Colo-rectal Cancer, run by CellMaxLife 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 3 inclusion and 8 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 2 Apr 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun-Tsui Chang (+886-2-26558455 ext. 404, joy@cellmaxlife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of circulating tumor cells (time frame: Prior to treatment or colonoscopy). 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 2 Apr 2018.