Circulating Tumor DNANCT04555369
The Value of ctDNA on Chemotherapy Efficacy for mCRC
A study testing ct-DNA in people with Circulating Tumor DNA, run by Fudan University at 1 site in China.
Trial summary
The study is designed to evaluate the value of ctDNA in predicting the drug efficacy of chemotherapy for metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circulating Tumor DNA
- What is being tested?
- ct-DNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2020to 1 Sep 2025
- Phase
- Interventional
- 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
Who may be able to join
- aged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma Eastern Cooperative Oncology Group performance status of 0 to 2 life expectancy of ≥ 3 months at least one measurable metastatic lesion have adequate bone marrow, hepatic, and renal function
Who cannot join
- patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction patients with symptomatic brain metastases active clinical severe infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jinjia Chang, MD,PhD, iamchangjinjia@163.com
Weijian Guo
About this study
Official title: Study on the Efficacy of Chemotherapy for Metastatic Colorectal Cancer Evaluated by Circulating Tumor DNA
The study is designed to evaluate the value of ctDNA in predicting the drug efficacy of chemotherapy for metastatic colorectal cancer.
- Conditions
- Circulating Tumor DNA
- Being tested
- ct-DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ct-DNAGenetic
Also called circulating tumor DNA
The enrolled mCRC patients will perform ct-DNA testing to evaluate drug efficacy of chemotherapy, at the time of baseline and after the first cycle of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| ct-DNA | Experimental | The enrolled mCRC patients will perform ct-DNA testing to evaluate drug efficacy of chemotherapy, at the time of baseline and after the first cycle of chemotherapy. Receives: Genetic: ct-DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
the response rate predicted by ct-DNA
Measured: 2 months
Secondary outcomes (2)
Progression free survival
Measured: 2 months
Overall survival
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start23 Sep 2020
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulating Tumor DNAStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weijian Guo, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555369
- Sponsor's protocol ID
- mCRC-ctDNA FUSCC
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy of Chemotherapy for Metastatic Colorectal Cancer Evaluated by Circulating Tumor DNA
- ClinicalTrials.gov ID
- NCT04555369
- Acronym / sponsor ID
- mCRC-ctDNA FUSCC
- Conditions
- Circulating Tumor DNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 18 Sep 2020 (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.
The study is designed to evaluate the value of ctDNA in predicting the drug efficacy of chemotherapy for metastatic colorectal cancer.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ct-DNA | Experimental | Genetic: ct-DNAThe enrolled mCRC patients will perform ct-DNA testing to evaluate drug efficacy of chemotherapy, at the time of baseline and after the first cycle of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged ≥18 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma Eastern Cooperative Oncology Group performance status of 0 to 2 life expectancy of ≥ 3 months at least one measurable metastatic lesion have adequate bone marrow, hepatic, and renal function
Key exclusion criteria (1 listed)
- patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction patients with symptomatic brain metastases active clinical severe infection
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 |
|---|---|---|
| ct-DNAAlso: circulating tumor DNAThe enrolled mCRC patients will perform ct-DNA testing to evaluate drug efficacy of chemotherapy, at the time of baseline and after the first cycle of chemotherapy. | Genetic | ct-DNA |
Primary outcome
Response rate
Time frame: 2 months
the response rate predicted by ct-DNA
2 secondary outcomes
Progression free survival
Time frame: 2 months
Overall survival
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Individual participant dataSharing planned: No
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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?
A study testing ct-DNA in people with Circulating Tumor DNA, run by Fudan 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 1 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 19 Jul 2021. 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 Weijian Guo, phD (8621-64175590, iamchangjinjia@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 2 months). 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 19 Jul 2021.