Clinical trial NCT06483919: The Predictive Value of Proteome Profiling for Brain Metastasis in Limited-Stage Small-Cell Lung Cancer
Official title: The Predictive Value of Proteome Profiling for Brain Metastasis in Limited-Stage Small-Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Small-cell Lung Cancer
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Limited-stage 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.

Eligibility criteria: 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

Primary outcomes:
measure: Brain metastases free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Xiangjiao Meng, PhD
role: STUDY_DIRECTOR
References: