NSCLC MRD ctDNANCT05441566
Significance of MRD After Surgery in Driver Gene-positive and Driver Gene-negative Stage IB-IIA NSCLC
An observational study of NSCLC MRD ctDNA, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
1. It has been controversial whether adjuvant therapy should be done for patients with stage IB NSCLC after surgery in clinical practice, and identifying patients with high-risk recurrence and those who can benefit from adjuvant therapy is an important clinical problem to be solved. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- NSCLC MRD ctDNA
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Dec 2026
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is an open-label, single-center study to explore the clinical significance of MRD in Chinese adult patients with operable stage I-II lung cancer with positive and negative driver gene mutations of NSCLC. The study will include 60 patients with stage I-II NSCLC who are treated surgically in our center.
Who may be able to join
- Patients with stage I-II operable NSCLC in AJCC TNM stage (8th edition) confirmed by clinical pathological staging;
- The physical condition and organ function allow surgery and postoperative adjuvant therapy；
- At the time of signing the informed consent form, the age is equal to or greater than 18 years old;
- Tumor histology or cytology confirmed NSCLC;
- Never received any surgery, radiotherapy, chemotherapy or molecular targeted anti-tumor therapy;
- Eastern Cooperative Oncology Group performance status score (ECOG PS) is 0 ~ 1 points;
- Patients agree and have the ability to follow the planned study visits, treatment plan, laboratory tests and other research steps;
- Expected survival time ≥ 6 months.
Who cannot join
- Patients with other malignant tumors;
- Patients with inoperable clinical evaluation;
- Patients with other serious diseases that may affect follow-up and significant short-term survival;
- Patients who have received previous anti-tumor treatment such as surgery, chemotherapy, targeted or immunotherapy;
- Eastern Cooperative Oncology Group performance status score (ECOG PS) > 2 points;
- Patients with clinically clear active infection, including but not limited to pneumonia;
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- Any other condition and social/psychological problems, etc., judged by the investigator that the patient is not suitable for participating in this study; can not accept the use of contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT) for clinical follow-up;
- Other researchers think it is not suitable;
- or can not comply with the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Dynamic Monitoring and Significance of Molecular Residual Disease After Surgery in Driver Gene-positive and Driver Gene-negative Stage IB-IIA NSCLC
- It has been controversial whether adjuvant therapy should be done for patients with stage IB NSCLC after surgery in clinical practice, and identifying patients with high-risk recurrence and those who can benefit from adjuvant therapy is an important clinical problem to be solved. Therefore, the first key scientific issue to be solved in this topic is to analyze the correlation between MRD detection results and both recurrence and adjuvant therapy efficacy by focusing on the stage IB-IIA postoperative NSCLC patient population. To provide clinical data to aid clinical screening of NSCLC patients at high risk of recurrence after surgery in stage IB-IIA.
2, if the detection of MRD has important clinical value such as accurately identifying the population at high risk of recurrence of stage IB-IIA NSCLC, the differences in MRD, etc. between driver gene-positive and -negative patients require further comparative analysis. The second key scientific issue to be solved in this topic is: the different role of MRD in driver gene-positive and driver gene-negative patients: comparison of positive rates, analysis of prognostic differences; and providing clinical data for elucidating the differences between driver gene-positive and -negative patients in MRD evaluation of lung cancer.
- If MRD is different between NSCLC patients with positive and negative driver genes in stage IB-IIA, is there a difference in the biological behavior of the tumors themselves between these two types of patients? Is there a difference in the ability of the tumor tissue itself to shed tumor cells to be released into the blood? The third scientific question to be addressed in this project is to explore the difference in the ability of patients with stage IB-IIA NSCLC to release ctDNA from their tumors by analyzing the correlation between detailed clinicopathological data and MRD. To provide a scientific basis for exploring the differences in tumor biological behavior between NSCLC driver gene positive and negative.
- Conditions
- NSCLC MRD ctDNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Driver gene-positive | Not described | |
| Driver gene-negative | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ctDNA levels after surgery 2 years
Measured: baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC MRD ctDNAStudies 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)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gui G Ding, Principal investigator, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441566
- Sponsor's protocol ID
- ShenzhenPH 0606
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 1 Jul 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 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Monitoring and Significance of Molecular Residual Disease After Surgery in Driver Gene-positive and Driver Gene-negative Stage IB-IIA NSCLC
- ClinicalTrials.gov ID
- NCT05441566
- Acronym / sponsor ID
- ShenzhenPH 0606
- Conditions
- NSCLC MRD ctDNA
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Jul 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.
- It has been controversial whether adjuvant therapy should be done for patients with stage IB NSCLC after surgery in clinical practice, and identifying patients with high-risk recurrence and those who can benefit from adjuvant therapy is an important clinical problem to be solved. Therefore, the first key scientific issue to be solved in this topic is to analyze the correlation between MRD detection results and both recurrence and adjuvant therapy efficacy by focusing on the stage IB-IIA postoperative NSCLC patient population. To provide clinical data to aid clinical screening of NSCLC patients at high risk of recurrence after surgery in stage IB-IIA.
2, if the detection of MRD has important clinical value such as accurately identifying the population at high risk of recurrence of stage IB-IIA NSCLC, the differences in MRD, etc. between driver gene-positive and -negative patients require further comparative analysis. The second key scientific issue to be solved in this topic is: the different role of MRD in driver gene-positive and driver gene-negative patients: comparison of positive rates, analysis of prognostic differences; and providing clinical data for elucidating the differences between driver gene-positive and -negative patients in MRD evaluation of lung cancer.
- If MRD is different between NSCLC patients with positive and negative driver genes in stage IB-IIA, is there a difference in the biological behavior of the tumors themselves between these two types of patients? Is there a difference in the ability of the tumor tissue itself to shed tumor cells to be released into the blood? The third scientific question to be addressed in this project is to explore the difference in the ability of patients with stage IB-IIA NSCLC to release ctDNA from their tumors by analyzing the correlation between detailed clinicopathological data and MRD. To provide a scientific basis for exploring the differences in tumor biological behavior between NSCLC driver gene positive and negative.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Driver gene-positive | – | – |
| Driver gene-negative | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is an open-label, single-center study to explore the clinical significance of MRD in Chinese adult patients with operable stage I-II lung cancer with positive and negative driver gene mutations of NSCLC. The study will include 60 patients with stage I-II NSCLC who are treated surgically in our center.
Key inclusion criteria (8 listed)
- Patients with stage I-II operable NSCLC in AJCC TNM stage (8th edition) confirmed by clinical pathological staging;
- The physical condition and organ function allow surgery and postoperative adjuvant therapy；
- At the time of signing the informed consent form, the age is equal to or greater than 18 years old;
- Tumor histology or cytology confirmed NSCLC;
- Never received any surgery, radiotherapy, chemotherapy or molecular targeted anti-tumor therapy;
Key exclusion criteria (9 listed)
- Patients with other malignant tumors;
- Patients with inoperable clinical evaluation;
- Patients with other serious diseases that may affect follow-up and significant short-term survival;
- Patients who have received previous anti-tumor treatment such as surgery, chemotherapy, targeted or immunotherapy;
- Eastern Cooperative Oncology Group performance status score (ECOG PS) > 2 points;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in ctDNA levels after surgery 2 years
Time frame: baseline and 2 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 1 Jul 2022.
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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.
Gui G Ding principal investigator
Shenzhen People's Hospital
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 NSCLC MRD ctDNA, run by Shenzhen People's 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 8 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 1 Jul 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ctDNA levels after surgery 2 years (time frame: baseline and 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 1 Jul 2022.