Advanced Lung Non-Small Cell CarcinomaCR1STALNCT05198154
ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC
An observational study of Advanced Lung Non-Small Cell Carcinoma, run by Fang Wu at 1 site in China.
Trial summary
This study aims to explore the correlation of circulating tumor DNA(ctDNA) and the risk of progression in patients with advanced NSCLC who have long-term benefit from first-line immunotherapy (PFS 12 months) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Non-Small Cell Carcinoma
- What is being tested?
- ctDNA detection
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2022to 30 Nov 2029
- How long will I take part?
- 3 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: Clinically confirmed advanced NSCLC patients with long-term benefit after first-line immunotherapy
Who may be able to join
- Age ≥ 18 years old
- Advanced non-small cell lung cancer (stage IIIB-IV), pathological types limited to squamous cell carcinoma or non-squamous cell carcinoma, driver gene mutations (EGFR/ALK/ROS1) were negative
- General condition: ECOG score 0 or 1
- First-line monotherapy or combination immunotherapy
- The long-term benefit of immunotherapy was defined as PFS=12months
- Tumor tissue samples can be obtained at the time of enrollment, and at least 5 ~ 10 sections can be generated, and the pathological report indicates that the overall tumor content is not less than 10% or NGS testing with a fixed-panel is available; or no tumor tissue is available.
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- At least one measurable lesion (except patients with CR after first-line treatment) can be evaluated according to RECIST1.1 standard.
- Have self-awareness, be able to understand the research scheme and voluntarily participate in the study, and can sign the informed consent form
- Have good compliance, be able to cooperate with the collection of specimens from each node and provide corresponding clinical information.
Who cannot join
- Serious primary diseases of the heart, liver and kidney
- Other malignant tumors within 3 years prior to diagnosis of NSCLC
- Women in pregnancy and lactation
- The active stage of human immunodeficiency virus (HIV) infection
- Patients with active systemic infection, pneumonia, tuberculosis, pericarditis
- Patients who cannot understand the content of the experiment and cannot cooperate and refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Oncology Department，Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
About this study
Official title: A Multicenter, Prospective Clinical Study of Circulating Tumor DNA Analysis to Monitor the Risk of Progression After Long-term Benefit to First-line Immunotherapy in Patients With Advanced NSCLC (CR1STAL)
This study aims to explore the correlation of circulating tumor DNA(ctDNA) and the risk of progression in patients with advanced NSCLC who have long-term benefit from first-line immunotherapy (PFS 12 months)
Read the detailed description
Evidence suggests that circulating tumor DNA (ctDNA) analysis can noninvasively identify minimal residual disease (MRD) in clinical oncology. The researches will be sharply increased about ctDNA potential clinical application in the near future. In the early stage of NSCLC, ctDNA has been indicated to identify those at high risk of recurrence after radical surgery. And this study will focus on those patients with advanced NSCLC who have long-term benefit from first-line immunotherapy (PFS 12 months). 20ml plasma will be collected concurrently with the imaging examination. Meanwhile, the investigators would like to explore the lead time of detectable ctDNA before regular imaging finding.
- Conditions
- Advanced Lung Non-Small Cell Carcinoma
- Being tested
- ctDNA detection
- Keywords
- ctDNA, advanced lung cancer, first-line immunotherapy, the risk of progression, minimal residual disease (MRD), long-term benefit
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ctDNA detectionDiagnostic test
High-depth sequencing method is used to detecting ctDNA.
| Study group | Role | What they receive |
|---|---|---|
| Advanced NSCLC patients with long-term benefit after first-line immunotherapy (Tumor-informed group) | The ctDNA detection will be performed using a tumor-informed analysis approach. This method requires the availability of tumor tissue samples or a fixed-panel next-generation sequencing (NGS) test. Receives: Diagnostic Test: ctDNA detection | |
| Advanced NSCLC patients with long-term benefit after first-line immunotherapy (Tumor-agnostic group) | The ctDNA detection will be performed using a tumor-agnostic analysis. This method does not require tumor tissue samples or an NGS testing panel, or in cases where tissue samples are available but fail to meet quality control standards. Receives: Diagnostic Test: ctDNA detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The duration from study enrollment to disease progression or death, whichever occurs first.
Measured: 3 years
Secondary outcomes (4)
The correlation of ctDNA and risk of progression
The correlation of ctDNA and risk of progression during the erolled observation process
Measured: 3 years
Lead time
Lead time defined as the interval between ctDNA detection and imaging of progression.
Measured: 3 years
Incidence of adverse events
the incidence of adverse events during the whole observation time
Measured: 3 years
Overall survival (OS)
Overall survival (OS) defined as the duration from study enrollment until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start24 Jan 2022
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Lung Non-Small Cell CarcinomaStudies 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
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fang Wu
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center, First Affiliated Hospital Xi'an Jiaotong University, Fujian Cancer Hospital, Third Affiliated Hospital of Third Military Medical University, Xiangya Hospital of Central South University, Qinghai Province Fifth People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhejiang Provincial People's Hospital, Hunan Cancer Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Second Affiliated Hospital, Zhejiang University, School of Medicine, Zhejiang Cancer Hospital, The First Affiliated Hospital of Guangzhou Medical University, Inner Mongolia People's Hospital, Guizhou Provincial People's Hospital, The Third Xiangya Hospital of Central South University, Yueyang Central Hospital, ZhuZhou Central Hospital, Zhangjiajie Affiliated Hospital of Hunan Normal University, Loudi Central Hospital, Cancer Hospital of Guangxi Medical University, First Affiliated Hospital of Kunming Medical University, The Affiliated Hospital of Inner Mongolia Medical University, Changsha Central Hospital, Hengyang Central Hospital, Xiangtan Central Hospital, Hunan University of Medicine General Hospital, Hunan Provincial People's Hospital, Hunan Provincial Hospital of Traditional Chinese Medicine, Yiyang Central Hospital, Hunan Shaoyang Central Hospital, Jiangsu Cancer Institute & Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, First Affiliated Hospital of Xinjiang Medical University, Renmin Hospital of Wuhan University, Changsha First Hospital, The Second People's Hospital of Huaihua, The First People's Hospital of Xiangtan City, Xiangxi Autonomous Prefecture People's Hospital, Chenzhou NO. 1 people's Hospital, Changde Hospital, Xiangya School of Medicine, Central South University, Wuhan TongJi Hospital, Changsha Third Hospital, Yongzhou Center Hospital, Liaoning Cancer Hospital & Institute
- Responsible party
- Sponsor-investigator, Fang Wu, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198154
- Sponsor's protocol ID
- XYEYY20211024
- Acronym
- CR1STAL
- Status last verified
- Feb 2026
- First submitted
- 1 Jan 2022
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Clinical Study of Circulating Tumor DNA Analysis to Monitor the Risk of Progression After Long-term Benefit to First-line Immunotherapy in Patients With Advanced NSCLC (CR1STAL)
- ClinicalTrials.gov ID
- NCT05198154
- Acronym / sponsor ID
- CR1STAL / XYEYY20211024
- Conditions
- Advanced Lung Non-Small Cell Carcinoma
- Keywords
- ctDNA, advanced lung cancer, first-line immunotherapy, the risk of progression, minimal residual disease (MRD), long-term benefit
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fang WuUniversity, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center, First Affiliated Hospital Xi'an Jiaotong University, Fujian Cancer Hospital, Third Affiliated Hospital of Third Military Medical University, Xiangya Hospital of Central South University, Qinghai Province Fifth People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhejiang Provincial People's Hospital, Hunan Cancer Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Second Affiliated Hospital, Zhejiang University, School of Medicine, Zhejiang Cancer Hospital, The First Affiliated Hospital of Guangzhou Medical University, Inner Mongolia People's Hospital, Guizhou Provincial People's Hospital, The Third Xiangya Hospital of Central South University, Yueyang Central Hospital, ZhuZhou Central Hospital, Zhangjiajie Affiliated Hospital of Hunan Normal University, Loudi Central Hospital, Cancer Hospital of Guangxi Medical University, First Affiliated Hospital of Kunming Medical University, The Affiliated Hospital of Inner Mongolia Medical University, Changsha Central Hospital, Hengyang Central Hospital, Xiangtan Central Hospital, Hunan University of Medicine General Hospital, Hunan Provincial People's Hospital, Hunan Provincial Hospital of Traditional Chinese Medicine, Yiyang Central Hospital, Hunan Shaoyang Central Hospital, Jiangsu Cancer Institute & Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, First Affiliated Hospital of Xinjiang Medical University, Renmin Hospital of Wuhan University, Changsha First Hospital, The Second People's Hospital of Huaihua, The First People's Hospital of Xiangtan City, Xiangxi Autonomous Prefecture People's Hospital, Chenzhou NO. 1 people's Hospital, Changde Hospital, Xiangya School of Medicine, Central South University, Wuhan TongJi Hospital, Changsha Third Hospital, Yongzhou Center Hospital, Liaoning Cancer Hospital & Institute
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 20 Jan 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.
This study aims to explore the correlation of circulating tumor DNA(ctDNA) and the risk of progression in patients with advanced NSCLC who have long-term benefit from first-line immunotherapy (PFS 12 months)
Detailed description
Evidence suggests that circulating tumor DNA (ctDNA) analysis can noninvasively identify minimal residual disease (MRD) in clinical oncology. The researches will be sharply increased about ctDNA potential clinical application in the near future. In the early stage of NSCLC, ctDNA has been indicated to identify those at high risk of recurrence after radical surgery. And this study will focus on those patients with advanced NSCLC who have long-term benefit from first-line immunotherapy (PFS 12 months). 20ml plasma will be collected concurrently with the imaging examination. Meanwhile, the investigators would like to explore the lead time of detectable ctDNA before regular imaging finding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advanced NSCLC patients with long-term benefit after first-line immunotherapy (Tumor-informed group) | – | Diagnostic Test: ctDNA detectionThe ctDNA detection will be performed using a tumor-informed analysis approach. This method requires the availability of tumor tissue samples or a fixed-panel next-generation sequencing (NGS) test. |
| Advanced NSCLC patients with long-term benefit after first-line immunotherapy (Tumor-agnostic group) | – | Diagnostic Test: ctDNA detectionThe ctDNA detection will be performed using a tumor-agnostic analysis. This method does not require tumor tissue samples or an NGS testing panel, or in cases where tissue samples are available but fail to meet quality control standards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinically confirmed advanced NSCLC patients with long-term benefit after first-line immunotherapy
Key inclusion criteria (9 listed)
- Age ≥ 18 years old
- Advanced non-small cell lung cancer (stage IIIB-IV), pathological types limited to squamous cell carcinoma or non-squamous cell carcinoma, driver gene mutations (EGFR/ALK/ROS1) were negative
- General condition: ECOG score 0 or 1
- First-line monotherapy or combination immunotherapy
- The long-term benefit of immunotherapy was defined as PFS=12months
Key exclusion criteria (6 listed)
- Serious primary diseases of the heart, liver and kidney
- Other malignant tumors within 3 years prior to diagnosis of NSCLC
- Women in pregnancy and lactation
- The active stage of human immunodeficiency virus (HIV) infection
- Patients with active systemic infection, pneumonia, tuberculosis, pericarditis
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 detectionHigh-depth sequencing method is used to detecting ctDNA. | Diagnostic test | Advanced NSCLC patients with long-term benefit after first-line immunotherapy (Tumor-agnostic group), Advanced NSCLC patients with long-term benefit after first-line immunotherapy (Tumor-informed group) |
Primary outcome
Progression-free survival (PFS)
Time frame: 3 years
The duration from study enrollment to disease progression or death, whichever occurs first.
4 secondary outcomes
The correlation of ctDNA and risk of progression
Time frame: 3 years
Lead time
Time frame: 3 years
Incidence of adverse events
Time frame: 3 years
Overall survival (OS)
Time frame: 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 31 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Advanced Lung Non-Small Cell Carcinoma, run by Fang Wu 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 6 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: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. 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?
Progression-free survival (PFS) (time frame: 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 31 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.