Neoplasms, Therapy-AssociatedNCT02523495
The Clinical Outcome and the Exploration of Related Biomarkers of Target Therapy in Metastasis Colorectal Cancer
An observational study of Neoplasms, Therapy-Associated, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer and explore some biomarkers that relate to target therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasms, Therapy-Associated
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Jul 2022
- How long will I take part?
- 5 Years
- 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: Metastasis colorectal cancer patients in Chinese Han population
Who may be able to join
- Metastasis colorectal cancer confirmed by histologically and radiography
- Receive target therapy over half a year
- Have a measurable lesions
Who cannot join
- 1. A history of other malignant tumors in five years
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Yuan Xianglin, Professional
About this study
Through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer and explore some biomarkers that relate to target therapy.
Read the detailed description
- Establish a clinical database of patients who are diagnosed with metastasis colorectal cancer in tongji hospital.
- Build a biological specimen banks of metastasis colorectal cancer through collecting blood samples from those patients who have reached an agreement with us.
- Through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer.
- To extract DNA from the blood and explore some biomarkers that related to target therapy in metastasis colorectal cancer.
- Conditions
- Neoplasms, Therapy-Associated
- Keywords
- Molecular Targeted Therapy, metastasis colorectal cancer, biomarker
- Medical subject headings
- Neoplasms, Second Primary
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startJun 2012
- Primary completionJul 2020 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, Therapy-AssociatedStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianglin Yuan, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523495
- Sponsor's protocol ID
- TJCC003-TTMCRC
- Status last verified
- Aug 2018
- First submitted
- 4 Aug 2015
- Last updated
- 7 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Outcome and the Exploration of Related Biomarkers of Target Therapy in Metastasis Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02523495
- Acronym / sponsor ID
- TJCC003-TTMCRC
- Conditions
- Neoplasms, Therapy-Associated
- Keywords
- Molecular Targeted Therapy, metastasis colorectal cancer, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 14 Aug 2015 (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.
Through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer and explore some biomarkers that relate to target therapy.
Detailed description
- Establish a clinical database of patients who are diagnosed with metastasis colorectal cancer in tongji hospital.
- Build a biological specimen banks of metastasis colorectal cancer through collecting blood samples from those patients who have reached an agreement with us.
- Through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer.
- To extract DNA from the blood and explore some biomarkers that related to target therapy in metastasis colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Metastasis colorectal cancer patients in Chinese Han population
Key inclusion criteria (3 listed)
- Metastasis colorectal cancer confirmed by histologically and radiography
- Receive target therapy over half a year
- Have a measurable lesions
Key exclusion criteria (1 listed)
- 1. A history of other malignant tumors in five years
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
overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 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.
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 Neoplasms, Therapy-Associated, run by Huazhong University of Science and Technology at 1 site in China.
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 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 7 Aug 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 China. 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 Yuan Xianglin, Professional (13667241722, yxl@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 5 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 7 Aug 2018.