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NCT02949154 Clinical Trial

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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02949154
Other study ID # 201600693
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2016
Est. completion date April 2017

Study information
Verified date May 2024
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (1)
Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Independent correlation between baseline serum LDH level and 18F-FDG uptake of tumour lesions 3 months
Secondary Correlation between baseline serum LDH level and tumour 18F-FDG uptake in subgroups separated by metastasis site 3 months
Secondary Correlation between baseline serum S100B level and tumour 18F-FDG uptake 3 months
Secondary Difference between tumour burden as measured on CT scan and on 18F-FDG-PET 3 months
Secondary Difference between tumour volume as determined by manual measurement or semiautomatic measurement 3 months
Secondary Correlation of baseline serum LDH level with tumour volume as measured on CT scan and as measured on 18F-FDG-PET scan 3 months
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