Status:

RECRUITING

MRD-guided Prognosis Prediction and Adjuvant Treatment Based on CTC and ctDNA in NSCLC

Lead Sponsor:

Jiangsu Cancer Institute & Hospital

Conditions:

Non-small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Brief Summary

This is a prospective cohort study, which aims to evaluate the effectiveness and superiority of a novel minimal residual disease-guided prognosis monitoring and adjuvant treatment in stage IIA-IIIC no...

Detailed Description

This observational study is a single-center, prospective cohort study, which aims to detect minimal residual disease (MRD) using circulating tumor cells (CTC) and circulating tumor DNA (ctDNA). To eva...

Eligibility Criteria

Inclusion

  • Written informed consent must be signed before implementing any enrollment-related procedures;
  • Age ≥18 years old;
  • Patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer, 8th Edition TNM staging);
  • There is no special restriction on the source of genetic test report.
  • According to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), there is at least one radiographically measurable lesion.
  • Have not received any previous systemic antitumor therapy for advanced diseases.
  • No serious abnormalities of hematopoietic function, heart, lung, liver, kidney function and immune system.
  • ECOG score: 0-1;
  • Expected survival time \> 3 months.

Exclusion

  • Received surgical treatment for lung tumors.
  • Received neoadjuvant chemotherapy or radiotherapy.
  • Received cellular therapy within the last 1 year.
  • Treated but uncontrolled diabetes, mellitus, asthma, autoimmune diseases and other chronic diseases.
  • Participated in other clinical trials (including research vaccines, drugs, medical devices, etc.) within one month.

Key Trial Info

Start Date :

February 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

February 1 2027

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06198868

Start Date

February 1 2024

End Date

February 1 2027

Last Update

January 12 2024

Active Locations (1)

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Jiangsu Cancer Institute & Hospital

Nanjing, Jiangsu, China, 210009