Development and Validation of Nomogram Predicting Survival in Chinese SCLC Patients

In this retrospective study, patients diagnosed with SCLC between January 2011 to September 2022 were identified from database of the Second Hospital of Shandong University. Following inclusion criteria should be met: (1) Had histologically or cytologically confirmed newly diagnosed SCLC; (2) No cancer treatment has been done before; (3) Complete clinical, laboratory, imaging, treatment data and follow-up information. The exclusion criteria included: Patients without complete records for pathological information, complete epidemiology and other key clinical information.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Other: initial chemotherapy response

Detailed Description

The investigators classified qualitative variables according to clinical practice. Age included less than 60 years, 61-66 years, and more than 67 years. The primary tumor location included left-sided and right-sided. The anatomic sites included lower and others. The smoking status included never smoker and ever smoker. The forms of performance status according to the Eastern Cooperative Oncology Group scale (ECOG PS) were ECOG ≤ 2, and ECOG ≥ 3. Five groups were formed according to clinical T stage (T0-1, T2, T3, T4, and T stage that could not be evaluated). Three groups were formed according to clinical N stage (N0-1, N2-3, and N stage that could not be evaluated). Some stages were unevaluated, on account of a portion of non-measurable tumor size and lymph node. Three groups were formed according to clinical M stage (M0, Ma-b, Mc). Four groups were formed according to clinical TNM stage (Ⅰ-Ⅱ, Ⅲ, Ⅳ and TNM stage that could not be evaluated). The common metastatic sites(brain, liver, and bone) of tumor was divided into none and yes. The hematologic markers (serum natrium , lactate dehydrogenase, carcinoembryonic antigen, neuron-specific enolase, cytokeratin 19 fragment, and pro-gastrin-releasing peptide) were divided into normal and abnormal. The above information was collected before treatment. The RECIST version 1.0 was used to assess tumor responses after initial imaging studies of commencing chemotherapy. Initial chemotherapy response is the first imaging examination of SCLC patient after starting chemotherapy. Six groups were formed according to initial response to chemotherapy (CR, PR, SD, PD, response that could not be evaluated, and no chemotherapy). Other treatments (radiotherapy, surgery, targeted therapy, immunotherapy, Interventional therapy, and whole-brain prophylactic cranial irradiation) was classified none and yes.

• Study Type: Observational
• Enrollment (Actual): 569

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

In this retrospective study, patients diagnosed with SCLC between January 2011 to September 2022 were identified from database of the Second Hospital of Shandong University.

Description

Inclusion Criteria:

1. Newly diagnosis of small cell lung cancer
2. No cancer treatment has been done before
3. Complete clinical, laboratory, imaging, treatment data and follow-up information

Exclusion Criteria:

1. Without complete records for pathological information, complete epidemiology and other key clinical information

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
training cohort; The investigators used the training cohort to develop the predictive nomogram with potential risk factors( initial response to chemotherapy)	Other: initial chemotherapy response; Initial chemotherapy response is the first imaging examination of SCLC patient after starting chemotherapy
validation cohort; The investigators used the validation cohort to verify the clinical utility and predictive ability	Other: initial chemotherapy response; Initial chemotherapy response is the first imaging examination of SCLC patient after starting chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	the Time Between the Discovery of the Tumor and the Patient's Death	January 2011 to September 2022

Collaborators and Investigators

• Sponsor: The Second Hospital of Shandong University

Publications and helpful links

General Publications

• Lara PN Jr, Redman MW, Kelly K, Edelman MJ, Williamson SK, Crowley JJ, Gandara DR; Southwest Oncology Group. Disease control rate at 8 weeks predicts clinical benefit in advanced non-small-cell lung cancer: results from Southwest Oncology Group randomized trials. J Clin Oncol. 2008 Jan 20;26(3):463-7. doi: 10.1200/JCO.2007.13.0344.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 8, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: ChineseSCLC2022