ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC (CR1STAL)

August 26, 2026 updated by: Fang Wu

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Oncology Department，Second Xiangya Hospital of Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Clinically confirmed advanced NSCLC patients with long-term benefit after first-line immunotherapy

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: ctDNA detection
High-depth sequencing method is used to detecting ctDNA.
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.
Diagnostic test: ctDNA detection
High-depth sequencing method is used to detecting ctDNA.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 3 years
The duration from study enrollment to disease progression or death, whichever occurs first.
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The correlation of ctDNA and risk of progression
Time Frame: 3 years
The correlation of ctDNA and risk of progression during the erolled observation process
3 years
Lead time
Time Frame: 3 years
Lead time defined as the interval between ctDNA detection and imaging of progression.
3 years
Incidence of adverse events
Time Frame: 3 years
the incidence of adverse events during the whole observation time
3 years
Overall survival (OS)
Time Frame: 5 years
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.
5 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 3 years
ORR is defined as the proportion of study participants who achieve complete response (CR) or partial response (PR) among the total study participants.
3 years
Factors influencing ctDNA detection
Time Frame: 3 years
Analyze the factors affecting ctDNA shedding and non-shedding.
3 years
Differences between ctDNA MRD and other peripheral blood biomarkers.
Time Frame: 3 years
Differences between ctDNA MRD and other peripheral blood biomarkers.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fang Wu

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zhejiang Cancer Hospital
Xiangya Hospital of Central South University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Fujian Cancer Hospital
Hunan Cancer Hospital
First Affiliated Hospital Xi'an Jiaotong University
Guizhou Provincial People's Hospital
The Third Xiangya Hospital of Central South University
Jiangsu Cancer Institute & Hospital
The First Affiliated Hospital of Guangzhou Medical University
Hunan Provincial People's Hospital
ZhuZhou Central Hospital
Renmin Hospital of Wuhan University
Second Affiliated Hospital of Xi'an Jiaotong University
Zhejiang Provincial People's Hospital
First Affiliated Hospital of Xinjiang Medical University
Wuhan TongJi Hospital
The Affiliated Hospital of Inner Mongolia Medical University
Inner Mongolia People's Hospital
Cancer Hospital of Guangxi Medical University
Loudi Central Hospital
Xiangtan Central Hospital
Yueyang Central Hospital
Shaoyang Central Hospital
Yiyang Central Hospital
Changsha Central Hospital
Hengyang Central Hospital
Xiangxi Autonomous Prefecture People's Hospital
The Third Hospital of Changsha
Xiangya Changde Hospital
Liaoning Cancer Hospital & Institute
Changsha First Hospital
Chenzhou NO. 1 people's Hospital
Third Affiliated Hospital of Third Military Medical University
First Affiliated Hospital of Kunming Medical University
Zhangjiajie Affiliated Hospital of Hunan Normal University
Yongzhou Center Hospital
The Second People's Hospital of Huaihua
The First People's Hospital of Xiangtan City
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Sun Yat-Sen University Cancer Center
Hunan University of Medicine General Hospital
Second Affiliated Hospital, Zhejiang University, School of Medicine
Qinghai Province Fifth People's Hospital
Hunan Provincial Hospital of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XYEYY20211024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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