Elevated LDH Serum Levels and FDG-PET in Metastatic Melanoma Patients

Completed

• Conditions: Melanoma

• Registration Number: NCT02949154
• Lead Sponsor: University Medical Center Groningen

Brief Summary

A retrospective study investigating the relationship between FDG-PET uptake and LDH levels.

Detailed Description

Patient characteristics, tumour characteristics including the BRAF mutation status and baseline serum S100B and LDH levels of each patient will be retrospectively determined from the electronical patient file. In each patient, tumour burden and 18F-FDG uptake of the tumour lesions will be measured using multiple standard quantification parameters of the baseline 18F-FDG-PET scan. Tumour burden will also be measured on the baseline contrast enhanced CT scan. The correlation of each FDG-PET parameter with baseline LDH and S100B levels, respectively, will be analyzed using univariate and multivariate regression analysis.

Study Timeline

• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-31
• Study Start: 2016-11
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• All patients >18 years with histologically proven metastatic melanoma (American Joint Committee on Cancer [AJCC] stage IV melanoma) treated in the UMCG between May 2014 and December 2015.

Exclusion Criteria

• participation in interventional studies
• missing baseline 18F-FDG PET scan and/or baseline contrast enhanced CT scan
• missing baseline serum LDH level
• missing BRAF mutation status, concurrent malignancies or a history of previous malignancies.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Independent correlation between baseline serum LDH level and 18F-FDG uptake of tumour lesions	3 months

Secondary Outcome Measures

Name	Time	Method
Correlation between baseline serum S100B level and tumour 18F-FDG uptake	3 months
Correlation of baseline serum LDH level with tumour volume as measured on CT scan and as measured on 18F-FDG-PET scan	3 months
Difference between tumour volume as determined by manual measurement or semiautomatic measurement	3 months
Correlation between baseline serum LDH level and tumour 18F-FDG uptake in subgroups separated by metastasis site	3 months
Difference between tumour burden as measured on CT scan and on 18F-FDG-PET	3 months

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands