Radiomics of Immunotherapeutics Response Evaluation and Prediction

NCT04079283 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 285

Last updated 2020-04-02

No results posted yet for this study

Summary

This study aims to investigate the feasibility and efficiency of CT radiomic analysis which serves as a high through-put analytical strategy applied to image big-data resource in evaluating and predicting the response of immunotherapeutics. A multi-center retrospective diagnostic test has been designed for this aim to compare the predictive performance of clinical model, qualitative model incorporating semantic CT features and image-based quantitative radiomic model. The reference standard of therapeutic effect is determined by the latest evaluation result utilizing iRECIST within 365 days after recruited. This study intends to enroll 400 participates who had been diagnosed with advanced somatic solid tumor confirmed by histo- or cyto-pathological examination and were planning to receive immunotherapy.

Conditions

Interventions

DIAGNOSTIC_TEST

Clinical

Clinical: A diagnostic model incorporating clinical variables (Age, Pathological diagnosis, level of serum tumor biomarkers etc.)

DIAGNOSTIC_TEST

Semantic

Semantic: A diagnostic model incorporating semantic radiological features (shape, location, border, density etc.)

DIAGNOSTIC_TEST

Radiomic

Radiomic: A diagnostic model incorporating quantitative radiomic features (histogram, texture, morphology etc.)

Sponsors & Collaborators

  • Tianjin Chest Hospital

    collaborator OTHER
  • Shandong Tumor Hospital

    collaborator OTHER
  • West China Hospital

    collaborator OTHER
  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER
  • Sun Yat-sen University

    collaborator OTHER
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER
  • Liaoning Cancer Hospital & Institute

    collaborator OTHER
  • Hubei Cancer Hospital

    collaborator OTHER
  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER
  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Zhaoxiang Ye, M.D, Ph.D · Tianjin Medical University Cancer Institute and Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-12-31
Completion
2020-02-25

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04079283 on ClinicalTrials.gov