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NCT05778253Recruiting

The Role of ctDNA Testing Plus AI-based Pathology in Resectable LSCC

Circulating Tumor DNA (ctDNA) Dynamic Monitoring Plus Artificial Intelligence (AI)-Based Pathology Predict the Efficacy of Chemoimmunotherapy in Resectable Lung Squamous Cell Carcinoma (LSCC)

Source: ClinicalTrials.gov · Last updated 21 Mar 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 dynamic monitoring plus AI-based pathology can more effectively predict the therapeutic effect of neoadjuvant chemoimmunotherapy for resectable lung squamous cell carcinoma, so as to accurately guide clinical diagnosis and treatment.

Status (registry)
Recruiting
Study type
Observational
Enrollment
50 (estimated)
First submitted
23 Feb 2023
Start date
23 Mar 2023
Primary completion date
23 Sept 2028
Lead sponsor
Second Xiangya Hospital of Central South University
Diseases
Lung cancer
NCT number
NCT05778253

What you commit to

  • Study type: Observational
  • Planned participants: 50
  • From 23 Mar 2023 to the primary completion date, 23 Sept 2028
  • 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
  • Previous use of CTLA-4, PD-1, or PD-L1 immune checkpoint inhibitors
  • Patients who have undergone other clinical drug trials

Other illness

  • Patients with interstitial lung disease
  • Patients with acute or chronic infectious disease

Other

  • Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form
  • Non-squamous NSCLC
  • Unresectable IIIa-IIIb tumor
  • Pregnant and lactating women

Who the study is looking for

  • Histopathology or cytology confirmed the lung squamous cell carcinoma
  • Age ranging from 18 to 75
  • Agree to participate in this study and sign an informed consent form
  • Treatment-naive tumor
  • According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage II-IIIb resectable or potentially resectable tumor
  • Sufficient tissue/blood samples are available to meet research requirements
  • The ECOG PS score is 0-1

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.