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

January 10, 2024 updated by: Rong Yin, MD PhD, Jiangsu Cancer Institute & Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A total of 60 patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC would be enrolled from Jiangsu Cancer Institute & Hospital. In resectable group, we would enroll 20 early-stage cases and 20 operable patients for neoadjuvant treatment . In non-resectable group, 20 advanced-stage inoperable patients would be enrolled.

Description

Inclusion Criteria:

  1. Written informed consent must be signed before implementing any enrollment-related procedures;
  2. Age ≥18 years old;
  3. 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)；
  4. There is no special restriction on the source of genetic test report.
  5. According to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), there is at least one radiographically measurable lesion.
  6. Have not received any previous systemic antitumor therapy for advanced diseases.
  7. No serious abnormalities of hematopoietic function, heart, lung, liver, kidney function and immune system.
  8. ECOG score: 0-1;
  9. Expected survival time > 3 months.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Operable group
Early-stage patients with radical surgery or operable patients with neoadjuvant treatment
Procedure: Operable
Enrolled patients capable of surgical treatment
Inoperable group
Advanced-stage patients receive non-surgery therapies.
Procedure: Operable
Enrolled patients capable of surgical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the date of first dose of study drug until date of death from any cause (up to approximately 5 years )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Cancer Institute & Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

December 28, 2023

First Submitted That Met QC Criteria

December 28, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023K-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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