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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06483919

Enrollment

228

Registered

2024-07-03

Start date

2023-10-01

Completion date

2025-01-30

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small-cell Lung Cancer

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Brain metastases free survival	2 years	The length of time after the ending of primary treatment that the patient survives without any brain metastases signs or symptoms

Secondary

Measure	Time frame	Description
Overall survival	2 years	The length of time after the ending of primary treatment that the patient survives.

Countries

China

Outcome results