The Predictive Value of Proteome Profiling for Brain Metastasis in Limited-Stage Small-Cell Lung Cancer

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

ACTIVE_NOT_RECRUITING

Total Enrollment

228 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-01-30

Brief Summary

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This study aims to evaluate the predictive value of proteome profiling for brain metastasis in limited-stage small-cell lung cancer

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Detailed Description

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Small-cell lung cancer (SCLC) constitutes approximately 15% of all lung cancer cases and is characterized by a highly aggressive disease course and poor prognosis. The brain is the most common metastatic site of SCLC, and it is also an important cause of high mortality. More than 20% of SCLC patients have developed brain metastasis (BM) at the first diagnosis. Prophylactic cranial irradiation (PCI), as an essential part of the treatment of limited-stage small-cell lung cancer (LS-SCLC), inevitably leads to neurotoxicity. Therefore, there is an urgent need for a convenient and effective prediction model to realize the early prediction of SCLC brain metastasis. Patients at high risk of brain metastases were treated with individualized PCI.

In the current study, the investigators have analyzed the proteome profiling using Data-independent Acquisition mass spectrometry (DIA-MS) method in formalin-fixed paraffin-embedded (FFPE) tissues from patients with limited-stage small-cell lung cancer. The prognostic biomarkers were developed based on machine learning in the non-PCI group. Patients in the non-PCI group were classified into modeling cohort and external validation cohort . Furthermore, the prognostic value of the candidate biomarkers be evaluated in a prospective cohort . Based on the brain metastasis model, patients were divided into high- and low-risk groups. The benefit value of PCI was analyzed in high-risk and low-risk groups.

Conditions

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Small-cell Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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SCLC patients with brain metastasis

No interventions assigned to this group

SCLC patients without brain metastasis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Age \> 18 years old
2. Histological / pathologic proved limited-stage small-cell lung cancer
3. Achieved a complete response (CR) or partial response (PR) after first-line CRT

Exclusion Criteria

1. Simultaneous participation in another clinical trial
2. Brain MRI was not performed during treatment and follow-up
3. The follow-up time was less than 2 years
4. Patients presenting with other known malignancies for which they are receiving treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No