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NCT Number: NCT06198868

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

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 non-small cell lung cancer.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jiangsu Cancer Institute & Hospital

Nanjing, Jiangsu, 210009, China

Location status: Recruiting

Location contact

Jifeng Feng, M.D., Ph.D.

CONTACT

[email protected]

Siwei Wang, M.D., Ph.D.

CONTACT

[email protected]

About this study

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 evaluate the effectiveness and superiority of MRD detection, we enroll operable or inoperable IIA-IIIC stage NSCLC patients, and single-cell RNA sequencing and genomic sequencing would be performed for CTC and ctDNA, respectively.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Operable

Procedure

Enrolled patients capable of surgical treatment

Primary outcomes

  1. To evaluate the Progression-free Survival (PFS)

    Time frame: From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first), up to approximately 3 years

    Progression-free survival (PFS) is defined as the time from the start of treatment to the occurrence of tumor progression or death due to any cause based on RECIST 1.1 assessed by investigator review.

Secondary outcomes

  1. To evaluate the Overall Survival (OS)

    Time frame: From the date of first dose of study drug until date of death from any cause (up to approximately 5 years )

    Overall Survival (OS) was measured from the date of first dose of study drug until date of death from any cause. Participants who were lost to follow-up and the participants who were alive at the date of data cutoff was censored at the date the participant was last known alive, whichever came earlier.

Study contacts

Contact information is provided by the study sponsor or research team.

Rong Yin, M.D., Ph.D.

CONTACT

[email protected]

18305185629

Sponsors and collaborators

Lead sponsor

Jiangsu Cancer Institute & Hospital

Other

Registry information

Official study title

Minimal Residual Disease (MRD) Guided Prognosis Prediction and Adjuvant Treatment Based on Expression and Mutational Signatures of Circulating Tumor Cell (CTC) and Circulating Tumor DNA (ctDNA) in Non-small Cell Lung Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 10, 2024
Registry last updated
Jan 12, 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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