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NCT Number: NCT05965024

Exploration on the Value of MRD Based on ctDNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location status: Recruiting

Location contact

Peng Zhang, PhD

CONTACT

[email protected]

02165115006

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old, regardless of gender;
  • Patients with pathological diagnosis of non-small cell lung cancer and clinical staging of stage IB-IIIB;
  • Able to undergo radical surgical treatment;
  • Physical condition score (ECOG) ≤1;
  • The expected survival time exceeds 24 months;
  • Volunteer to participate in this study and sign an informed consent form.

Exclusion criteria

  • Individuals with a history of other malignant tumors within 5 years;
  • Those who have undergone neoadjuvant therapy before surgery;
  • Postoperative incision margin R1 or incision margin R2;
  • Those who have undergone a blood transfusion within 2 weeks before the surgery;
  • Individuals with systemic inflammatory response syndrome;
  • Those with serious diseases of important organs such as the heart, lungs, kidneys, and brain;
  • Participants in other clinical trials within the past 30 days and have taken investigational drugs;
  • 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;
  • Researchers believe that it is not appropriate to participate in this experiment.

Treatment and study plan

Primary outcomes

  1. 2-year recurrence-free survival rate

    Time frame: Up to 24 months

    Recurrence-free survival means the time from the date of surgery to the first recorded date of disease recurrence or patient death, whichever occurs earlier. 2-year recurrence-free survival rate means the rate of patients survive without recurrence for 2 years or more.

Secondary outcomes

  1. Median recurrence-free survival

    Time frame: up to 60 months

    Recurrence-free survival means the time from the date of surgery to the first recorded date of disease recurrence or patient death, whichever occurs earlier. Median recurrence-free survival means the median value of recurrence-free survival.

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

Exploration on the Value of Molecular Residual Disease Based on Circulating Tumor DNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Jul 28, 2023
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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