Metastatic Colorectal CancerNCT05635630
Predictive Value of ctDNA for NED Status in mCRC and Its Utility in Guiding Therapeutic Intervention
A study testing ctDNA and adjuvant therapy and ctDNA in people with Metastatic Colorectal Cancer and No Evidence of Disease Status, run by Fudan University at 1 site in China.
Trial summary
The goal of this clinical trial is to detect the prognostic value of longitudinal monitoring circulating tumor DNA (ctDNA) for no evidence of disease (NED) status in metastatic colorectal cancer (mCRC) patients and its utility in guiding therapeutic intervention. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Metastatic Colorectal Cancer, No Evidence of Disease Status, ctDNA Monitoring
- What is being tested?
- ctDNA and adjuvant therapy and ctDNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2022to 24 Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old. Both male and female are eligible.
- Late stage metastatic colorectal adenocarcinoma diagnosed by histology or cytology.
- With potential opportunity of achieving NED status (including liver metastasis, lung metastasis, solitary lymph node metastasis, ovarian metastasis or focal pelvic metastasis), regardless of neo-adjuvant therapy or transforming therapy.
- Patients who are intended for focal therapy, radical surgery, focal radiotherapy, radiofrequency ablation or interventional therapy (anhydrous alcohol injection or cryotherapy)
- Eastern Cooperative Oncology Group (ECOG) grade 1-2.
- Approve the informed consent.
- Available for tumor sample obtained by resection or aspiration.
- Available for peripheral blood collection (10mL per tube for 2 tubes)
Who cannot join
- Cannot get histologic or cytologic diagnosis.
- Clinical tumor, node, and metastasis (cTNM) stage I-III according to the American Joint Committee on Cancer (AJCC), the 8th edition.
- Accompany with widespread metastasis and cannot achieve NED status by focal therapy, such as bone metastasis, peritoneum metastasis, diffuse liver or lung metastasis or malignant effusion, etc.
- Inadequate bone marrow reserve and organ function.
- Uncontrolled or severe systemic diseases, such as uncontrolled hyperplasia, severe infection, hepatitic B virus (HBV) infection, hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV) infection, etc.
- History of alcohol or drug abuse.
- Pregnant or lactating women.
- Cannot get tumor sample.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
Junjie Peng, 021-64175590, pengjj67@hotmail.com
About this study
Official title: Predictive Value of Circulating Tumor DNA (ctDNA) for no Evidence of Disease (NED) Status in Metastatic Colorectal Cancer (mCRC) and Its Utility in Guiding Therapeutic Intervention: an Open-label, Prospective, Phase II Cohort Study
The goal of this clinical trial is to detect the prognostic value of longitudinal monitoring circulating tumor DNA (ctDNA) for no evidence of disease (NED) status in metastatic colorectal cancer (mCRC) patients and its utility in guiding therapeutic intervention. The main questions it aims to answer are:
- Whether ctDNA monitoring could evaluate NED status ahead of normal radiologic monitoring. What about the concordance of evaluating NED status by ctDNA monitoring compared with normal radiologic monitoring?
- Whether the patients with ctDNA positive status could benefit from early therapeutic intervention.
Patients who receive any kinds of therapies with the aim of NED and are confirmed by clinical and radiologic examination will go through longitudinal ctDNA monitoring. According to the results of ctDNA monitoring, the patients will be divided into ctDNA positive group and ctDNA negative group. Patients in ctDNA positive group will receive individual therapeutic plan decided by the investigator. Patients in ctDNA negative group will receive regular examinations. When radiologic recurrences are confirmed, the patients will be re-evaluated for a second opportunity of radical resection.
- Being tested
- ctDNA and adjuvant therapy, ctDNA
- 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 and adjuvant therapyOther
Patients of ctDNA positive group receive individual adjuvant chemotherapy. The ctDNA status are evaluated every 2 months.
ctDNAOther
Patients of ctDNA negative group are monitored by ctDNA every 3 months.
| Study group | Role | What they receive |
|---|---|---|
| ctDNA positive | Experimental | Not described Receives: Other: ctDNA and adjuvant therapy |
| ctDNA negative | Experimental | Not described Receives: Other: ctDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival (RFS) time
To detect the RFS time in metastatic colorectal cancer (mCRC) patients with no evidence of disease (NED) status who received circulating tumor DNA (ctDNA) guided therapies.
Measured: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Secondary outcomes (4)
Overall survival (OS) time
To detect the OS time in mCRC patients with NED status who received ctDNA guided therapies.
Measured: From the date of surgery until the date of death from any cause, assessed up to 2 years.
The positive rate of ctDNA in mCRC patients with NED status.
When the NED status is confirmed by radiology post-operation, it will also be assessed the ctDNA positive rate.
Measured: Post-operation 1 month
The concordance index of ctDNA defined NED and radiology defined NED status.
In this study, we aim to evaluate the NED status by ctDNA and traditional radiologic methods. The concordance index will be used to detect the identity of two methods.
Measured: When the clinic trail is finished, up to 2 years.
The rate of achieving NED status when relapses happen.
When the diseases relapse during the follow-up. The multi-disciplinary treatment (MDT) team will discuss the opportunities to achieve a second NED status.
Measured: When the relapses happen, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start24 Jun 2022
- Primary completion24 Dec 2023 (estimated)
- Study completion24 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Responsible party
- Principal investigator, Junjie Peng, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635630
- Sponsor's protocol ID
- ctDNA-nedCRC
- Status last verified
- Nov 2022
- First submitted
- 3 Nov 2022
- Last updated
- 2 Dec 2022
- 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 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Circulating Tumor DNA (ctDNA) for no Evidence of Disease (NED) Status in Metastatic Colorectal Cancer (mCRC) and Its Utility in Guiding Therapeutic Intervention: an Open-label, Prospective, Phase II Cohort Study
- ClinicalTrials.gov ID
- NCT05635630
- Acronym / sponsor ID
- ctDNA-nedCRC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 24 Dec 2023 (estimated)
- Study completion
- 24 Dec 2025 (estimated)
- First posted
- 2 Dec 2022 (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 goal of this clinical trial is to detect the prognostic value of longitudinal monitoring circulating tumor DNA (ctDNA) for no evidence of disease (NED) status in metastatic colorectal cancer (mCRC) patients and its utility in guiding therapeutic intervention. The main questions it aims to answer are:
- Whether ctDNA monitoring could evaluate NED status ahead of normal radiologic monitoring. What about the concordance of evaluating NED status by ctDNA monitoring compared with normal radiologic monitoring?
- Whether the patients with ctDNA positive status could benefit from early therapeutic intervention.
Patients who receive any kinds of therapies with the aim of NED and are confirmed by clinical and radiologic examination will go through longitudinal ctDNA monitoring. According to the results of ctDNA monitoring, the patients will be divided into ctDNA positive group and ctDNA negative group. Patients in ctDNA positive group will receive individual therapeutic plan decided by the investigator. Patients in ctDNA negative group will receive regular examinations. When radiologic recurrences are confirmed, the patients will be re-evaluated for a second opportunity of radical resection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ctDNA positive | Experimental | Other: ctDNA and adjuvant therapy |
| ctDNA negative | Experimental | Other: ctDNA |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years old. Both male and female are eligible.
- Late stage metastatic colorectal adenocarcinoma diagnosed by histology or cytology.
- With potential opportunity of achieving NED status (including liver metastasis, lung metastasis, solitary lymph node metastasis, ovarian metastasis or focal pelvic metastasis), regardless of neo-adjuvant therapy or transforming therapy.
- Patients who are intended for focal therapy, radical surgery, focal radiotherapy, radiofrequency ablation or interventional therapy (anhydrous alcohol injection or cryotherapy)
- Eastern Cooperative Oncology Group (ECOG) grade 1-2.
Key exclusion criteria (8 listed)
- Cannot get histologic or cytologic diagnosis.
- Clinical tumor, node, and metastasis (cTNM) stage I-III according to the American Joint Committee on Cancer (AJCC), the 8th edition.
- Accompany with widespread metastasis and cannot achieve NED status by focal therapy, such as bone metastasis, peritoneum metastasis, diffuse liver or lung metastasis or malignant effusion, etc.
- Inadequate bone marrow reserve and organ function.
- Uncontrolled or severe systemic diseases, such as uncontrolled hyperplasia, severe infection, hepatitic B virus (HBV) infection, hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV) infection, etc.
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 and adjuvant therapyPatients of ctDNA positive group receive individual adjuvant chemotherapy. The ctDNA status are evaluated every 2 months. | Other | ctDNA positive |
| ctDNAPatients of ctDNA negative group are monitored by ctDNA every 3 months. | Other | ctDNA negative |
Primary outcome
Relapse-free survival (RFS) time
Time frame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
To detect the RFS time in metastatic colorectal cancer (mCRC) patients with no evidence of disease (NED) status who received circulating tumor DNA (ctDNA) guided therapies.
4 secondary outcomes
Overall survival (OS) time
Time frame: From the date of surgery until the date of death from any cause, assessed up to 2 years.
The positive rate of ctDNA in mCRC patients with NED status.
Time frame: Post-operation 1 month
The concordance index of ctDNA defined NED and radiology defined NED status.
Time frame: When the clinic trail is finished, up to 2 years.
The rate of achieving NED status when relapses happen.
Time frame: When the relapses happen, up to 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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CRC
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 ctDNA and adjuvant therapy and ctDNA in people with Metastatic Colorectal Cancer and No Evidence of Disease Status, 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 8 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 Dec 2022. 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 Junjie Peng (+86-021-64175590, pengjj67@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (RFS) time (time frame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 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 2 Dec 2022.