Colorectal CancersPhase 1NCT01828918
Biomarkers for the Early Diagnosis, Prediction, Prognosis for Colorectal Cancers
A Phase 1 study testing microRNAs in people with Colorectal Cancers, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Recent basic and clinical research on the circulating tumor cells (CTCs) in CRC patients takes potential diagnostics, prognostics, and applications into consideration, especially the molecular detection of CTCs in peripheral blood. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Colorectal Cancers
- What is being tested?
- microRNAs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2012to Dec 2016
- Phase
- Phase 1
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 y/o
- Histological / pathologic and image study proved colorectal cancer
- Patients with adequate tissue for biomarkers analysis
- Patients voluntary sign informed consent
Who cannot join
- Patients who are not met with either one of items which mentioned above.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City, Kaohsiung, 807
Jaw-Yuan Wang, Professor, +886-7-3121101 ext. 5583, cy614112@ms14.hinet.net
Jaw-Yuan Wang, Professor
About this study
Official title: Kaohsiung Medical University Hospital
Recent basic and clinical research on the circulating tumor cells (CTCs) in CRC patients takes potential diagnostics, prognostics, and applications into consideration, especially the molecular detection of CTCs in peripheral blood. Moreover, identification of therapeutic targets on CTCs and real-time monitoring of CTCs in cancer patients undergoing systemic therapy are the most important future clinical applications. CTCs measures may be useful to guide change in treatment decisions.
Read the detailed description
Colorectal cancer (CRC) is one of the most frequent malignancies and is also the third major cause of cancer-related death in Taiwan, with over 11,000 new cases of CRC were diagnosed and more than 4,400 Taiwanese died from CRC in 2008 (Department of Health). CRC is regarded as the accumulation of acquired genetic and epigenetic changes causing disorders in cell growth, differentiation and apoptosis resulting in transformation of normal colonic epithelium to colon adenocarcinoma.
Recent basic and clinical research on the circulating tumor cells (CTCs) in CRC patients takes potential diagnostics, prognosis, and applications into consideration, especially the molecular detection of CTCs in peripheral blood. Moreover, identification of therapeutic targets on CTCs and real-time monitoring of CTCs in cancer patients undergoing systemic therapy are the most important future clinical applications. The investigators divide the current project into three dimensions to include all the biomarkers related to diagnostic, prognostic and predictive roles for the potential clinical implication. Sub-project 1: prognostic validation and economic evaluation of biochips/biomarkers. Sub-project 2: evaluation of biomarkers for tailored therapy. Sub-project 3: identification and validation of novel biomarkers for early detection. After accomplishment of three sub-projects, a comprehensive network including early diagnostic, prognostic and predictive biomarkers/biochips for high-risk screening, postoperative surveillance, therapeutic strategies of CRC patients will be formed.
- Conditions
- Colorectal Cancers
- Being tested
- microRNAs
- Keywords
- early diagnosis, prediction, prognosis
- Medical subject headings
- Colorectal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microRNAsGenetic
| Study group | Role | What they receive |
|---|---|---|
| early recurrence | Other | find the postoperative early relapse out Receives: Genetic: microRNAs |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative early recurrence
Measured: within 12 months postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancersStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Academia Sinica, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828918
- Sponsor's protocol ID
- KMUH-IRB-2012-03-02 (II)
- Status last verified
- Jun 2012
- First submitted
- 27 Jan 2013
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kaohsiung Medical University Hospital
- ClinicalTrials.gov ID
- NCT01828918
- Acronym / sponsor ID
- KMUH-IRB-2012-03-02 (II)
- Conditions
- Colorectal Cancers
- Keywords
- early diagnosis, prediction, prognosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- Academia Sinica, Taiwan
- Study start
- Jun 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Apr 2013 (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.
Recent basic and clinical research on the circulating tumor cells (CTCs) in CRC patients takes potential diagnostics, prognostics, and applications into consideration, especially the molecular detection of CTCs in peripheral blood. Moreover, identification of therapeutic targets on CTCs and real-time monitoring of CTCs in cancer patients undergoing systemic therapy are the most important future clinical applications. CTCs measures may be useful to guide change in treatment decisions.
Detailed description
Colorectal cancer (CRC) is one of the most frequent malignancies and is also the third major cause of cancer-related death in Taiwan, with over 11,000 new cases of CRC were diagnosed and more than 4,400 Taiwanese died from CRC in 2008 (Department of Health). CRC is regarded as the accumulation of acquired genetic and epigenetic changes causing disorders in cell growth, differentiation and apoptosis resulting in transformation of normal colonic epithelium to colon adenocarcinoma.
Recent basic and clinical research on the circulating tumor cells (CTCs) in CRC patients takes potential diagnostics, prognosis, and applications into consideration, especially the molecular detection of CTCs in peripheral blood. Moreover, identification of therapeutic targets on CTCs and real-time monitoring of CTCs in cancer patients undergoing systemic therapy are the most important future clinical applications. The investigators divide the current project into three dimensions to include all the biomarkers related to diagnostic, prognostic and predictive roles for the potential clinical implication. Sub-project 1: prognostic validation and economic evaluation of biochips/biomarkers. Sub-project 2: evaluation of biomarkers for tailored therapy. Sub-project 3: identification and validation of novel biomarkers for early detection. After accomplishment of three sub-projects, a comprehensive network including early diagnostic, prognostic and predictive biomarkers/biochips for high-risk screening, postoperative surveillance, therapeutic strategies of CRC patients will be formed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| early recurrence | Other | Genetic: microRNAsfind the postoperative early relapse out |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 y/o
- Histological / pathologic and image study proved colorectal cancer
- Patients with adequate tissue for biomarkers analysis
- Patients voluntary sign informed consent
Key exclusion criteria (1 listed)
- Patients who are not met with either one of items which mentioned above.
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 |
|---|---|---|
| microRNAs | Genetic | early recurrence |
Primary outcome
postoperative early recurrence
Time frame: within 12 months postoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
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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.
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing microRNAs in people with Colorectal Cancers, run by Kaohsiung Medical University Chung-Ho 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 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 11 Apr 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative early recurrence (time frame: within 12 months postoperation). 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 11 Apr 2013.