Advanced Colorectal CancerNCT05495672
Circulating Tumor DNA Guided Therapeutic Strategies for CRC Patients With Small Pulmonary Nodules
A study testing Local treatment in people with Advanced Colorectal Cancer and Circulating Tumor DNA, run by Junjie Peng at 1 site in China.
Trial summary
The clinical diagnosis and treatment of small pulmonary nodules (suspected to be lung metastases) in advanced colorectal cancer patients remain controversy. Previous studies have shown that tumor-informed circulating tumor DNA (ctDNA) blood testing can sensitively detect residual cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Colorectal Cancer, Circulating Tumor DNA
- What is being tested?
- Local treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤80 years old, regardless of gender;
- Pathologically confirmed as adenocarcinoma of advanced colorectal cancer;
- Lung lesions only, which was considered as metastatic by imaging consultation, and clinically diagnosed as lung metastasis of colorectal cancer;
- Multiple lung lesions are allowed, but the maximum lesion diameter should be less than or equal to 2 cm;
- For lesions larger than 1 cm, local treatment is planned, such as radical surgical resection or local radiotherapy, radio frequency ablation or interventional therapy (absolute alcohol treatment or cryotherapy);
- Eastern Cooperative Oncology Group (ECOG) score 1 ~ 2;
Show all 10Show fewer
- The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study;
- Surgical specimens or puncture specimens containing tumor tissue are available;
- 20 mL of peripheral blood are available (10 mL per tube, two tubes in total);
- Agreed to follow up for at least 2 years.
Who cannot join
- The pathology was not confirmed by enteroscopic biopsy or biopsy of metastatic lesions;
- Patients with stage I-III colorectal cancer;
- Primary lung cancer, GGO, tuberculosis and other non metastatic conditions were excluded after diagnosis by imaging consultation;
- Presence of metastasis other than lung;
- Insufficient organ function, such as severe abnormal hemogram, abnormal liver and kidney function;
- Any signs of severe or uncontrolled systemic diseases that the researcher believes may have a significant patient risk/benefit balance, including uncontrolled hypertension, severe infection, hepatitis B, hepatitis C and human immunodeficiency virus;
- History of alcoholism or drug abuse;
- Pregnant or lactating patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
About this study
Official title: Circulating Tumor DNA Guided Therapeutic Strategies for Colorectal Cancer Patients With Small Pulmonary Nodules Suspected to be Metastases: an Open-Label, Prospective, Phase II Cohort Study
The clinical diagnosis and treatment of small pulmonary nodules (suspected to be lung metastases) in advanced colorectal cancer patients remain controversy. Previous studies have shown that tumor-informed circulating tumor DNA (ctDNA) blood testing can sensitively detect residual cancer. Postoperative ctDNA in colorectal cancer patients is a valuable biomarker to identify minimal residual disease (MRD) after radical resection, which is possibly useful in redefining the risk group of patients and guiding postoperative treatment. This study aimed to explore the clinical value of therapeutic strategies based on tumor-informed ctDNA test in advanved colorectal cancer patients with small pulmonary nodules.
- Conditions
- Advanced Colorectal Cancer, Circulating Tumor DNA
- Being tested
- Local treatment
- Keywords
- advanced colorectal cancer, lung metastasis, circulating tumor DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local treatmentProcedure or surgery
Radical surgical resection, local radiotherapy, radiofrequency ablation (RFA) or interventional therapy (absolute alcohol or cryotherapy).
The equipment used for RFA of lung lesions consisted of the radiofrequency generator (CelonLab POWER), cold circulation pump (Celon Aquaflow Ⅲ), radiofrequency needle electrode (Celon proSurge: T20, T30 and T40 is an electrode length of 20, 30 and 40 mm respectively, and maximum output power of 20, 30 and 40 W; Olympus Surgical Technologies Europe, Hamburg, Germany).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1-Arm A: the largest pulmonary nodule is less than or equal to 1 cm, ctDNA positive | Experimental | ctDNA is detected before curative treatment. Subjects with ctDNA positive before treatment will receive curative treatments for pulmonary nodules such as surgery, radio frequency ablation or stereotactic body radiotherapy. ctDNA will be detected after curative treatment and then every three months until progression or 2 years. At the same time, routine post treatment follow-up will be performed. Receives: Procedure: Local treatment |
| Cohort 1-Arm B: the largest pulmonary nodule is less than or equal to 1 cm, ctDNA negative | No intervention | Subjects with ctDNA negative will undergo routine follow-up. ctDNA will be detected every three months until progression or 2 years. |
| Cohort 2-Arm C: the largest pulmonary nodule is between 1 cm to 2 cm, ctDNA positive | Experimental | ctDNA is detected before curative treatment. Subjects with ctDNA positive before treatment will receive curative treatments for pulmonary nodules such as surgery, radio frequency ablation or stereotactic body radiotherapy.
ctDNA is rechecked following treatment. Subjects with ctDNA positive after treatment will receive chemotherapy. Subjects with ctDNA negative after curative treatment will undergo routine follow-up.
After treatment, ctDNA will be detected every three months until progression or 2 years. At the same time, routine post treatment follow-up will be performed. Receives: Procedure: Local treatment |
| Cohort 2-Arm D: the largest pulmonary nodule is between 1 cm to 2 cm, ctDNA negative | No intervention | Subjects with ctDNA negative will undergo routine follow-up. ctDNA will be detected every three months until progression or 2 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) in advanced colorectal cancer patients with metastatic small pulmonary nodules under ctDNA guided therapeutic strategies
Measured: From date of treatment until the date of first documented progression or date of death from any cause, assessed up to 36 months.
Secondary outcomes (4)
ctDNA positive rate in colorectal cancer patients with metastatic small pulmonary nodules
Measured: 4 weeks
ctDNA positive prediction rate (Consistent with histopathological result as the standard for comparison)
Measured: 8 weeks
The ctDNA clearance rate after local treatment
Measured: 8 weeks
The ctDNA clearance rate after chemotherapy in patients achieving NED (Cohort 2)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Junjie Peng
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai OrigiMed Co., Ltd.
- Responsible party
- Sponsor-investigator, Junjie Peng, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495672
- Sponsor's protocol ID
- ctDNA-nedCRC-lung
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2022
- Last updated
- 10 Aug 2022
- Results posted
- 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 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA Guided Therapeutic Strategies for Colorectal Cancer Patients With Small Pulmonary Nodules Suspected to be Metastases: an Open-Label, Prospective, Phase II Cohort Study
- ClinicalTrials.gov ID
- NCT05495672
- Acronym / sponsor ID
- ctDNA-nedCRC-lung
- Conditions
- Advanced Colorectal Cancer, Circulating Tumor DNA
- Keywords
- advanced colorectal cancer, lung metastasis, circulating tumor DNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Junjie PengUniversity, hospital or other
- Collaborators
- Shanghai OrigiMed Co., Ltd.
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 10 Aug 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 clinical diagnosis and treatment of small pulmonary nodules (suspected to be lung metastases) in advanced colorectal cancer patients remain controversy. Previous studies have shown that tumor-informed circulating tumor DNA (ctDNA) blood testing can sensitively detect residual cancer. Postoperative ctDNA in colorectal cancer patients is a valuable biomarker to identify minimal residual disease (MRD) after radical resection, which is possibly useful in redefining the risk group of patients and guiding postoperative treatment. This study aimed to explore the clinical value of therapeutic strategies based on tumor-informed ctDNA test in advanved colorectal cancer patients with small pulmonary nodules.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1-Arm A: the largest pulmonary nodule is less than or equal to 1 cm, ctDNA positive | Experimental | Procedure: Local treatmentctDNA is detected before curative treatment. Subjects with ctDNA positive before treatment will receive curative treatments for pulmonary nodules such as surgery, radio frequency ablation or stereotactic body radiotherapy. ctDNA will be detected after curative treatment and then every three months until progression or 2 years. At the same time, routine post treatment follow-up will be performed. |
| Cohort 1-Arm B: the largest pulmonary nodule is less than or equal to 1 cm, ctDNA negative | No intervention | –Subjects with ctDNA negative will undergo routine follow-up. ctDNA will be detected every three months until progression or 2 years. |
| Cohort 2-Arm C: the largest pulmonary nodule is between 1 cm to 2 cm, ctDNA positive | Experimental | Procedure: Local treatmentctDNA is detected before curative treatment. Subjects with ctDNA positive before treatment will receive curative treatments for pulmonary nodules such as surgery, radio frequency ablation or stereotactic body radiotherapy. ctDNA is rechecked following treatment. Subjects with ctDNA positive after treatment will receive chemotherapy. Subjects with ctDNA negative after curative treatment will undergo routine follow-up. After treatment, ctDNA will be detected every three months until progression or 2 years. At the same time, routine post treatment follow-up will be performed. |
| Cohort 2-Arm D: the largest pulmonary nodule is between 1 cm to 2 cm, ctDNA negative | No intervention | –Subjects with ctDNA negative will undergo routine follow-up. ctDNA will be detected every three months until progression or 2 years. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 and ≤80 years old, regardless of gender;
- Pathologically confirmed as adenocarcinoma of advanced colorectal cancer;
- Lung lesions only, which was considered as metastatic by imaging consultation, and clinically diagnosed as lung metastasis of colorectal cancer;
- Multiple lung lesions are allowed, but the maximum lesion diameter should be less than or equal to 2 cm;
- For lesions larger than 1 cm, local treatment is planned, such as radical surgical resection or local radiotherapy, radio frequency ablation or interventional therapy (absolute alcohol treatment or cryotherapy);
Key exclusion criteria (8 listed)
- The pathology was not confirmed by enteroscopic biopsy or biopsy of metastatic lesions;
- Patients with stage I-III colorectal cancer;
- Primary lung cancer, GGO, tuberculosis and other non metastatic conditions were excluded after diagnosis by imaging consultation;
- Presence of metastasis other than lung;
- Insufficient organ function, such as severe abnormal hemogram, abnormal liver and kidney function;
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 |
|---|---|---|
| Local treatmentRadical surgical resection, local radiotherapy, radiofrequency ablation (RFA) or interventional therapy (absolute alcohol or cryotherapy). The equipment used for RFA of lung lesions consisted of the radiofrequency generator (CelonLab POWER), cold circulation pump (Celon Aquaflow Ⅲ), radiofrequency needle electrode (Celon proSurge: T20, T30 and T40 is an electrode length of 20, 30 and 40 mm respectively, and maximum output power of 20, 30 and 40 W; Olympus Surgical Technologies Europe, Hamburg, Germany). | Procedure or surgery | Cohort 1-Arm A: the largest pulmonary nodule is less than or equal to 1 cm, ctDNA positive, Cohort 2-Arm C: the largest pulmonary nodule is between 1 cm to 2 cm, ctDNA positive |
Primary outcome
Progression-free survival (PFS) in advanced colorectal cancer patients with metastatic small pulmonary nodules under ctDNA guided therapeutic strategies
Time frame: From date of treatment until the date of first documented progression or date of death from any cause, assessed up to 36 months.
4 secondary outcomes
ctDNA positive rate in colorectal cancer patients with metastatic small pulmonary nodules
Time frame: 4 weeks
ctDNA positive prediction rate (Consistent with histopathological result as the standard for comparison)
Time frame: 8 weeks
The ctDNA clearance rate after local treatment
Time frame: 8 weeks
The ctDNA clearance rate after chemotherapy in patients achieving NED (Cohort 2)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Advanced Colorectal Cancer
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Not yet recruitingObservational study
Multidimensional Study Designed to Develop a Methodological Framework Based on MRI Data to Predict Pathological Complete Response (pCR) in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Treatment
Rectal Cancer, Chemoradiotherapy
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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 Local treatment in people with Advanced Colorectal Cancer and Circulating Tumor DNA, run by Junjie Peng 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 10 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 10 Aug 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, MD, PhD (86-18017317122, pengjj67@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) in advanced colorectal cancer patients with metastatic small pulmonary nodules under ctDNA guided therapeutic strategies (time frame: From date of treatment until the date of first documented progression or date of death from any cause, assessed up to 36 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 10 Aug 2022.