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OpenTrials
Completed

NCT Number: NCT05673798

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

initial chemotherapy response

Other

Initial chemotherapy response is the first imaging examination of SCLC patient after starting chemotherapy

Primary outcomes

  1. Overall Survival

    Time frame: January 2011 to September 2022

    the Time Between the Discovery of the Tumor and the Patient's Death

Sponsors and collaborators

Lead sponsor

The Second Hospital of Shandong University

Other

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2023
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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