NCT05822284Not yet recruiting
ctDNA-MRD in Stage IIIB-C NSCLC Patients Treated With Induction Chemoimmunotherapy
The Role of Dynamic Circulating Tumor DNA-Molecular Residual Disease (ctDNA-MRD) Testing in Stage IIIB-C Oncogene-negative NSCLC Patients Treated With Induction Chemoimmunotherapy in the Multidisciplinary Team (MDT) Model of Diagnosis and Treatment
Source: ClinicalTrials.gov · Last updated 20 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this observational study is to explore whether ctDNA-MRD dynamic monitoring can more effectively predict the therapeutic effect of induction chemoimmunotherapy followed by surgery or non-surgical treatment for stage IIIB-C driver-negative NSCLC in the MDT model, so as to accurately guide clinical diagnosis and treatment.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 4 Apr 2023
- Start date
- Apr 2023
- Primary completion date
- Mar 2029
- Lead sponsor
- Second Xiangya Hospital of Central South University
- Diseases
- Lung cancer
- NCT number
- NCT05822284
What you commit to
- Study type: Observational
- Planned participants: 50
- From Apr 2023 to the primary completion date, Mar 2029
- 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
- Patients with solid organ or blood system transplantation
- Patients who have undergone other clinical drug trials
Other illness
- Small cell lung cancer
- Tumor directly invades esophagus, heart, aorta, diaphragm, trachea, or carina, or is considered unresectable even following induction therapy
- Patients with interstitial lung disease
- Patients with acute or chronic infectious disease
Lab values
- Previous use of recombinant cytotoxic T-lymphocyte associated antigen 4 (CTLA-4), programmed cell death 1 (PD-1), or programmed cell death ligand 1 (PD-L1) immune checkpoint inhibitors
Other
- Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form
- Driver gene positivity
- Pregnant and lactating women
Who the study is looking for
- Histopathology or cytology confirmed the non-small cell lung cancer
- Age ranging from 18 to 75
- Agree to participate in this study and sign an informed consent form
- Treatment-naive tumor
- Driver gene negativity
- According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage IIIB-C potentially resectable tumor
- The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0-1
Age in the registry: 18 years to 75 years · 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 |
|---|---|---|---|
| Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.