Non-small Cell Lung CancerNCT06198868
MRD-guided Prognosis Prediction and Adjuvant Treatment Based on CTC and ctDNA in NSCLC
An observational study of Non-small Cell Lung Cancer, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial summary
This is a prospective cohort study, which aims to evaluate the effectiveness and superiority of a novel minimal residual disease-guided prognosis monitoring and adjuvant treatment in stage IIA-IIIC non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Operable
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 Feb 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: A total of 60 patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC would be enrolled from Jiangsu Cancer Institute \& Hospital. In resectable group, we would enroll 20 early-stage cases and 20 operable patients for neoadjuvant treatment . In non-resectable group, 20 advanced-stage inoperable patients would be enrolled.
Who may be able to join
- Written informed consent must be signed before implementing any enrollment-related procedures;
- Age ≥18 years old;
- Patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer, 8th Edition TNM staging)；
- There is no special restriction on the source of genetic test report.
- According to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), there is at least one radiographically measurable lesion.
- Have not received any previous systemic antitumor therapy for advanced diseases.
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- No serious abnormalities of hematopoietic function, heart, lung, liver, kidney function and immune system.
- ECOG score: 0-1;
- Expected survival time > 3 months.
Who cannot join
- Received surgical treatment for lung tumors.
- Received neoadjuvant chemotherapy or radiotherapy.
- Received cellular therapy within the last 1 year.
- Treated but uncontrolled diabetes, mellitus, asthma, autoimmune diseases and other chronic diseases.
- Participated in other clinical trials (including research vaccines, drugs, medical devices, etc.) within one month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, 210009
Jifeng Feng, M.D., Ph.D., fjif@vip.sina.com
Siwei Wang, M.D., Ph.D., wangsiwei@njmu.edu.cn
About this study
Official title: Minimal Residual Disease (MRD) Guided Prognosis Prediction and Adjuvant Treatment Based on Expression and Mutational Signatures of Circulating Tumor Cell (CTC) and Circulating Tumor DNA (ctDNA) in Non-small Cell Lung Cancer
This is a prospective cohort study, which aims to evaluate the effectiveness and superiority of a novel minimal residual disease-guided prognosis monitoring and adjuvant treatment in stage IIA-IIIC non-small cell lung cancer.
Read the detailed description
This observational study is a single-center, prospective cohort study, which aims to detect minimal residual disease (MRD) using circulating tumor cells (CTC) and circulating tumor DNA (ctDNA). To evaluate the effectiveness and superiority of MRD detection, we enroll operable or inoperable IIA-IIIC stage NSCLC patients, and single-cell RNA sequencing and genomic sequencing would be performed for CTC and ctDNA, respectively.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Operable
- Keywords
- NSCLC, Minimal Residual Disease, Prognosis monitoring, Adjuvant treatment
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OperableProcedure or surgery
Enrolled patients capable of surgical treatment
| Study group | Role | What they receive |
|---|---|---|
| Operable group | Early-stage patients with radical surgery or operable patients with neoadjuvant treatment Receives: Procedure: Operable | |
| Inoperable group | Advanced-stage patients receive non-surgery therapies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the Progression-free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the start of treatment to the occurrence of tumor progression or death due to any cause based on RECIST 1.1 assessed by investigator review.
Measured: From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first), up to approximately 3 years
Secondary outcomes (1)
To evaluate the Overall Survival (OS)
Overall Survival (OS) was measured from the date of first dose of study drug until date of death from any cause. Participants who were lost to follow-up and the participants who were alive at the date of data cutoff was censored at the date the participant was last known alive, whichever came earlier.
Measured: From the date of first dose of study drug until date of death from any cause (up to approximately 5 years )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Yin, MD PhD, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198868
- Sponsor's protocol ID
- 2023K-011
- Status last verified
- Jan 2024
- First submitted
- 28 Dec 2023
- Last updated
- 12 Jan 2024
- 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 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Residual Disease (MRD) Guided Prognosis Prediction and Adjuvant Treatment Based on Expression and Mutational Signatures of Circulating Tumor Cell (CTC) and Circulating Tumor DNA (ctDNA) in Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06198868
- Acronym / sponsor ID
- 2023K-011
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC, Minimal Residual Disease, Prognosis monitoring, Adjuvant treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 10 Jan 2024 (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 is a prospective cohort study, which aims to evaluate the effectiveness and superiority of a novel minimal residual disease-guided prognosis monitoring and adjuvant treatment in stage IIA-IIIC non-small cell lung cancer.
Detailed description
This observational study is a single-center, prospective cohort study, which aims to detect minimal residual disease (MRD) using circulating tumor cells (CTC) and circulating tumor DNA (ctDNA). To evaluate the effectiveness and superiority of MRD detection, we enroll operable or inoperable IIA-IIIC stage NSCLC patients, and single-cell RNA sequencing and genomic sequencing would be performed for CTC and ctDNA, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operable group | – | Procedure: OperableEarly-stage patients with radical surgery or operable patients with neoadjuvant treatment |
| Inoperable group | – | –Advanced-stage patients receive non-surgery therapies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 60 patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC would be enrolled from Jiangsu Cancer Institute \& Hospital. In resectable group, we would enroll 20 early-stage cases and 20 operable patients for neoadjuvant treatment . In non-resectable group, 20 advanced-stage inoperable patients would be enrolled.
Key inclusion criteria (9 listed)
- Written informed consent must be signed before implementing any enrollment-related procedures;
- Age ≥18 years old;
- Patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer, 8th Edition TNM staging)；
- There is no special restriction on the source of genetic test report.
- According to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), there is at least one radiographically measurable lesion.
Key exclusion criteria (5 listed)
- Received surgical treatment for lung tumors.
- Received neoadjuvant chemotherapy or radiotherapy.
- Received cellular therapy within the last 1 year.
- Treated but uncontrolled diabetes, mellitus, asthma, autoimmune diseases and other chronic diseases.
- Participated in other clinical trials (including research vaccines, drugs, medical devices, etc.) within one month.
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 |
|---|---|---|
| OperableEnrolled patients capable of surgical treatment | Procedure or surgery | Operable group |
Primary outcome
To evaluate the Progression-free Survival (PFS)
Time frame: From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first), up to approximately 3 years
Progression-free survival (PFS) is defined as the time from the start of treatment to the occurrence of tumor progression or death due to any cause based on RECIST 1.1 assessed by investigator review.
1 secondary outcome
To evaluate the Overall Survival (OS)
Time frame: From the date of first dose of study drug until date of death from any cause (up to approximately 5 years )
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- 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.
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 Non-small Cell Lung Cancer, run by Jiangsu Cancer Institute & Hospital 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 9 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rong Yin, M.D., Ph.D. (18305185629, rong_yin@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the Progression-free Survival (PFS) (time frame: From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first), up to approximately 3 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 12 Jan 2024.