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Trial Title:
Significance of MRD Monitoring in Patients With Potentially Resectable Stage III Non-small Cell Lung Cancer
NCT ID:
NCT06081777
Condition:
NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
MRD, potentially resectable NSCLC, stage III
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Stratification of postoperative ctDNA status can effectively assess the risk of
recurrence in patients. In addition, the multi-node dynamic monitoring of ctDNA is more
effective in predicting the recurrence risk of patients. In this study, EGFR/ALK negative
potentially resectable Stage III non-small cell lung cancer were enrolled. Baseline
tissues, Peripheral blood samples of patients at baseline puncture tissue, after
neoadjuvant therapy, after surgery (if any), after adjuvant therapy, and at multiple
nodes during follow-up were collected for 1021-MRD analysis through tumor-informed
personalized monitoring MRD test kit. This study aim to explore MRD biomarker in patients
with potentially resectable stage III non-small cell lung cancer.
Detailed description:
In this prospective study, 65 patients with potentially operable non-small cell lung
cancer without driving gene EGFR/ALK mutation in stage III were enrolled in this
prospective study. peripheral blood samples from multiple nodes after neoadjuvant
therapy, postoperative (if any), adjuvant therapy and follow-up were collected and
analyzed by high-throughput sequencing in the target region. Patients were enrolled in
the study for 1 year, followed up for 2 years, and the study lasted for 3 years. The
patients were followed up for 2 years according to the standard diagnosis and treatment
path, with a total of 9 times of follow-up, all of which were 3-month follow-up plan of
the standard diagnosis and treatment path, and the follow-up examination was conducted in
accordance with clinical standards.
Criteria for eligibility:
Study pop:
1. Capable of giving signed informed consent, age ≥ 18 and ≤ 80.
2. patients with stage Ⅲ non-small cell lung cancer confirmed by histology or cytology
have potential surgical opportunities.
3. No driving gene EGFR/ALK mutation.
4. PS = 0-1.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Capable of giving signed informed consent, age ≥ 18 and ≤ 80.
2. patients with stage Ⅲ non-small cell lung cancer confirmed by histology or cytology
have potential surgical opportunities.
3. No driving gene EGFR/ALK mutation.
4. PS = 0-1.
5. the treatment process cooperated with the provision of clinicopathological and
imaging data needed in the research process, followed up and collected the blood of
the clinical efficacy evaluation nodes, and agreed to use the test data for
follow-up research and product development.
Exclusion Criteria:
1. patients suffering from other malignant tumors.
2. patients change the treatment regimen before receiving the specified treatment or
before the disease progresses.
3. Patients could not cooperate with the study for follow-up according to the defined
clinical follow-up period;
4. Patients were unable to accept or provide imaging and other designated therapeutic
evaluation means.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yuyan Wang
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Bo Jia
Contact backup:
Last name:
Han Yin
Start date:
November 25, 2022
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Geneplus-Beijing Co. Ltd.
Agency class:
Industry
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06081777
