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Trial Title:
Exploration on the Value of MRD Based on ctDNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer
NCT ID:
NCT05965024
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Recurrence
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Based on the unique patented MONOD and Methyl Titan methylation sequencing technology on
lung cancer tissue and blood samples, a lung cancer MRD monitoring panel is designed. The
panel is used to detect molecular residual disease of stage IB-IIIB non-small cell lung
cancer patients underwent radical surgery, explore personalized analysis models, and
conduct research on recurrence monitoring for non-small cell lung cancer patients.
Criteria for eligibility:
Study pop:
Patients with pathological diagnosis of non-small cell lung cancer and clinical staging
of stage IB-IIIB
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old, regardless of gender;
2. Patients with pathological diagnosis of non-small cell lung cancer and clinical
staging of stage IB-IIIB;
3. Able to undergo radical surgical treatment;
4. Physical condition score (ECOG) ≤1;
5. The expected survival time exceeds 24 months;
6. Volunteer to participate in this study and sign an informed consent form.
Exclusion Criteria:
1. Individuals with a history of other malignant tumors within 5 years;
2. Those who have undergone neoadjuvant therapy before surgery;
3. Postoperative incision margin R1 or incision margin R2;
4. Those who have undergone a blood transfusion within 2 weeks before the surgery;
5. Individuals with systemic inflammatory response syndrome;
6. Those with serious diseases of important organs such as the heart, lungs, kidneys,
and brain;
7. Participants in other clinical trials within the past 30 days and have taken
investigational drugs;
8. Due to various reasons, sampling cannot be completed, samples do not meet the
requirements, or baseline samples (preoperative and postoperative plasma samples,
tumor tissue samples) are incomplete;
9. Researchers believe that it is not appropriate to participate in this experiment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Zhang, PhD
Phone:
02165115006
Email:
zhangpeng1121@tongji.edu.cn
Start date:
October 25, 2023
Completion date:
August 2028
Lead sponsor:
Agency:
Shanghai Pulmonary Hospital, Shanghai, China
Agency class:
Other
Source:
Shanghai Pulmonary Hospital, Shanghai, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05965024
