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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02949154

Enrollment

Registered

2016-10-31

Start date

2016-11-30

Completion date

2017-04-30

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results