Skip to main content
OpenTrials
Completed

NCT Number: NCT02949154

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Independent correlation between baseline serum LDH level and 18F-FDG uptake of tumour lesions

    Time frame: 3 months

Secondary outcomes

  1. Correlation between baseline serum LDH level and tumour 18F-FDG uptake in subgroups separated by metastasis site

    Time frame: 3 months

  2. Correlation between baseline serum S100B level and tumour 18F-FDG uptake

    Time frame: 3 months

  3. Difference between tumour burden as measured on CT scan and on 18F-FDG-PET

    Time frame: 3 months

  4. Difference between tumour volume as determined by manual measurement or semiautomatic measurement

    Time frame: 3 months

  5. Correlation of baseline serum LDH level with tumour volume as measured on CT scan and as measured on 18F-FDG-PET scan

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2016
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.