NCT05198154Active, not recruiting
ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC
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)
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 1 Jan 2022
- Start date
- 24 Jan 2022
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Fang Wu
- Diseases
- Lung cancer
- NCT number
- NCT05198154
What you commit to
- Study type: Observational
- Planned participants: 100
- From 24 Jan 2022 to the primary completion date, 30 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other malignant tumors within 3 years prior to diagnosis of NSCLC
Other illness
- Serious primary diseases of the heart, liver and kidney
- The active stage of human immunodeficiency virus (HIV) infection
- Patients with active systemic infection, pneumonia, tuberculosis, pericarditis
Other
- Women in pregnancy and lactation
- Patients who cannot understand the content of the experiment and cannot cooperate and refuse to sign informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oncology Department，Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.