Pathological and Nuclear Medicine Factors for Prognosis in Lung Carcinoma

NCT04276025 | Completed

• 1 other identifier: PANU022020
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Retrospective study in patients with therapy-naive non small cell lung carcinoma correlating presurgical F18-FDG-PET/CT imaging texture analysis data with postsurgical molecular pathology data and clinical patient outcome. Main aim is to identify pretherapeutic prognostic factors.

Conditions

NSCLC

Keywords

F18-FDG-PET/CT; Radiomics; Texture analysis; Lung cancer; Molecular pathology

Outcome Measures

Primary Outcomes (2)

• Progression free survival

  Time to progression (RECIST) based on routine clinical CT imaging on a quarterly base

  through study completion an average of 3 years after initial inclusion

• Overall survival

  Time to death based on clinical records

  through study completion an average of 3 years after initial inclusion

Study Arms (3)

German cohort Bayreuth

Retrospective analysis of clinical routine F18-FDG-PET/CT, molecular pathology and clinical outcome data.

Other: Clinical routine F18-FDG-PET/CT, molecular pathology and clinical outcome

German cohort Hof

Retrospective analysis of clinical routine F18-FDG-PET/CT, molecular pathology and clinical outcome data.

Other: Clinical routine F18-FDG-PET/CT, molecular pathology and clinical outcome

Chinese cohort Beijing

Retrospective analysis of clinical routine F18-FDG-PET/CT, molecular pathology and clinical outcome data.

Other: Clinical routine F18-FDG-PET/CT, molecular pathology and clinical outcome

Interventions

Clinical routine F18-FDG-PET/CT, molecular pathology and clinical outcome OTHER

Retrospective analysis of clinical routine F18-FDG-PET/CT, molecular pathology and clinical outcome data.

Chinese cohort Beijing; German cohort Bayreuth; German cohort Hof

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

German and chinese NSCLC patients who have received presurgical F18-FDG-PET/CT imaging followed by surgical removal of the primary lung tumor with postsurgical molecular pathology evaluation.

You may qualify if:

• Retrospective selection of both German cohort NSCLC patients with concomitant gene mutation results, CTCs accounting results and 18F-FDG PET/CT imaging data before lung tumor surgery (both German patient cohorts)
• Retrsopective selection of Chinese NSCLC patients with concomitant gene mutation results, CTCs accounting results and 18F-FDG PET/CT imaging data before lung tumor surgery (Chinese patient collective)

You may not qualify if:

• NSCLC patients with surgical resection of the target/primary tumor before 18F-FDG PET/CT scanning.
• NSCLC patients with elevated blood glucose levels (\> 150 mg/dl) immediately before 18F-FDG injection.
• based on PET CT scanning no concomitant malignancies

Sponsors & Collaborators

• Klinikum Bayreuth GmbH: lead
• Peking University Cancer Hospital & Institute: collaborator
• Sana Klinikum Hof: collaborator

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  PMID: 25900186 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Material from routine diagnosis. No additional material taken from the present study.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 19, 2020
• Study Start: July 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share