- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05198154
ctDNA Analysis to Monitor the Risk of Progression After First-line Immunotherapy in Patients With Advanced NSCLC (CR1STAL)
January 21, 2024 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
Recruiting
Conditions
Intervention / Treatment
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).
10ml plasma will be collected every three months until disease progression to interrogate ctDNA by high-depth panel sequencing, exploring its prediction value about the risk of progression.
Meanwhile, the investigators would like to explore the lead time of detectable ctDNA before regular imaging finding.
Study Type
Observational
Enrollment (Estimated)
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
- Name: Chunhong Hu, professor
- Phone Number: +86 13508486908
- Email: huchunh5829@126.com
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410011
- Recruiting
- Oncology Department,Second Xiangya Hospital of Central South University
-
Contact:
- Chunhong Hu, professor
- Phone Number: +86 13508486908
- Email: huchunh5829@126.com
-
Contact:
- Fang Wu, professor
- Phone Number: 13574858332
- Email: wufang4461@csu.edu.cn
-
-
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
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 from 18 to 75 years old
- Advanced non-small cell lung cancer (stage IIIB-IV), pathological types limited to squamous cell carcinoma or adenocarcinoma, 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%.
- 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 |
Intervention / Treatment |
---|---|
Advanced NSCLC patients with long-term benefit after first-line immunotherapy
For patients with advanced NSCLC who have long-term benefit (PFS 12 months) after first-line immunotherapy
|
High-depth sequencing method is used to detecting ctDNA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: 3 years
|
Time from the beginning of first-line immunotherapy to the first progression(PD) in patients with advanced NSCLC.
|
3 years
|
Secondary Outcome Measures
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: 3 years
|
Overall survival (OS) defined as the duration from the beginning of first-line immunotherapy 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.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
January 24, 2022
Primary Completion (Estimated)
December 30, 2024
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
January 1, 2022
First Submitted That Met QC Criteria
January 15, 2022
First Posted (Actual)
January 20, 2022
Study Record Updates
Last Update Posted (Estimated)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 21, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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
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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