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

NCT ID: NCT06198868

Last Updated: 2024-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2027-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Operable group

Early-stage patients with radical surgery or operable patients with neoadjuvant treatment

Operable

Intervention Type PROCEDURE

Enrolled patients capable of surgical treatment

Inoperable group

Advanced-stage patients receive non-surgery therapies.

No interventions assigned to this group

Interventions

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Operable

Enrolled patients capable of surgical treatment

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rong Yin, MD PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jiangsu Cancer Institute & Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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

Role: CONTACT

18305185629

Facility Contacts

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

Role: primary

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

Role: backup

Other Identifiers

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2023K-011

Identifier Type: -

Identifier Source: org_study_id

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