Colorectal CancerNCT03416478
The Implication of ctDNA in the Recurrence Surveillance of Stage II and III Colorectal Cancer
An observational study of Colorectal Cancer and ctDNA, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This study is to evaluate circulating tumor DNA (ctDNA) as a predictive and surveillant method for tumor recurrence in stage II and III colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, ctDNA, Surveillance
- What is being tested?
- ctDNA test
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2018to Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage II or stage III colorectal cancer must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria.
Who may be able to join
- Male or female ≥ 18 years of age on the day of signing informed consent.
- Patients must have histologically confirmed stage II or IIIcolorectal cancer.
- Patients must receive radical resection.
- Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.
Who cannot join
- Patient has severe anemia.
- Patients received neoadjuvant treatment.
- Patients received blood transfusion two weeks before or during the surgical resection.
- Patient has any other conditions, which, in the opinion of the Investigator, would interfere with the evaluation of the subject
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Sixth Affiliated Hospital, Sun Yet-sen University
Guangzhou
Xiaojian Wu, MD, PhD
About this study
Official title: The Implication of Plasma Circulating Tumor DNA (ctDNA) in the Recurrence Surveillance of Stage II and III Colorectal Cancer: a Prospective Study
This study is to evaluate circulating tumor DNA (ctDNA) as a predictive and surveillant method for tumor recurrence in stage II and III colorectal cancer (CRC).
Read the detailed description
This study will evaluate circulating tumor DNA (ctDNA) as a prognostic marker and as a monitor of a short-term disease recurrence in surgical resective stage II and stage III colorectal cancer (CRC). The investigators will recruit newly diagnosed CRC patients, systematically collect their blood samples at the following time point: before surgery, one week after surgery, every three months for the first year and every six months for the second year, which are coincidence with the recommended clinical follow-up. Patients' outcome and survival will be tracked. These study will permit assessment of ctDNA as a predictive and surveillant method for a short-term (two years) tumor recurrence in comparison with other parameters.
- Conditions
- Colorectal Cancer, ctDNA, Surveillance
- Being tested
- ctDNA test
- Keywords
- Colorectal Cancer, ctDNA, Surveillance
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNA testDiagnostic test
ctDNA test to find some possible mutation.
| Study group | Role | What they receive |
|---|---|---|
| ctDNA test group | Not described Receives: Diagnostic Test: ctDNA test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival
Measured: Two years
Secondary outcomes (1)
Overall survival
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study startJan 2018 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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 only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojian Wu, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Xiaojian Wu, MD, PhD, Principal investigator, Sixth Affiliated Hospital, Sun Yet-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416478
- Sponsor's protocol ID
- FFJC2017-01
- Status last verified
- Jan 2018
- First submitted
- 24 Jan 2018
- Last updated
- 1 Feb 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 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implication of Plasma Circulating Tumor DNA (ctDNA) in the Recurrence Surveillance of Stage II and III Colorectal Cancer: a Prospective Study
- ClinicalTrials.gov ID
- NCT03416478
- Acronym / sponsor ID
- FFJC2017-01
- Conditions
- Colorectal Cancer, ctDNA, Surveillance
- Keywords
- Colorectal Cancer, ctDNA, Surveillance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 31 Jan 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.
This study is to evaluate circulating tumor DNA (ctDNA) as a predictive and surveillant method for tumor recurrence in stage II and III colorectal cancer (CRC).
Detailed description
This study will evaluate circulating tumor DNA (ctDNA) as a prognostic marker and as a monitor of a short-term disease recurrence in surgical resective stage II and stage III colorectal cancer (CRC). The investigators will recruit newly diagnosed CRC patients, systematically collect their blood samples at the following time point: before surgery, one week after surgery, every three months for the first year and every six months for the second year, which are coincidence with the recommended clinical follow-up. Patients' outcome and survival will be tracked. These study will permit assessment of ctDNA as a predictive and surveillant method for a short-term (two years) tumor recurrence in comparison with other parameters.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ctDNA test group | – | Diagnostic Test: ctDNA test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage II or stage III colorectal cancer must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- Male or female ≥ 18 years of age on the day of signing informed consent.
- Patients must have histologically confirmed stage II or IIIcolorectal cancer.
- Patients must receive radical resection.
- Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.
Key exclusion criteria (4 listed)
- Patient has severe anemia.
- Patients received neoadjuvant treatment.
- Patients received blood transfusion two weeks before or during the surgical resection.
- Patient has any other conditions, which, in the opinion of the Investigator, would interfere with the evaluation of the subject
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 |
|---|---|---|
| ctDNA testctDNA test to find some possible mutation. | Diagnostic test | ctDNA test group |
Primary outcome
Disease Free Survival
Time frame: Two years
1 secondary outcome
Overall survival
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 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.
Xiaojian Wu, MD, PhD principal investigator
Sixth Affiliated Hospital, Sun Yet-sen University
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 Colorectal Cancer and ctDNA, run by Sixth Affiliated Hospital, Sun Yat-sen University 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 4 inclusion and 4 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 1 Feb 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 Xiaojian Wu, MD, PhD (86-020-38455325, wuxjian@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (time frame: Two 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 1 Feb 2018.