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CompletedNCT02949154Updated May 6, 2024

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

An observational study in Melanoma, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-06.

Sponsored by University Medical Center Groningen · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
65
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Melanoma

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03

In context

Melanoma

3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.

This study's enrollment of 65 is below the median of 182 across 448 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

University Medical Center Groningen is the lead sponsor of 625 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with metastatic melanoma

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
65 participants (actual)
Patient registry
No

Groups and cohorts

  • Metastatic melanoma patients

    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.

06

What researchers measure

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

07

Study locations

1 site
  • University Medical Center Groningen
    Groningen, 9713 GZ, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2016 to primary completion in Apr 2017, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2016
First posted
Oct 31, 2016
StartActual
Nov 2016
Primary completionActual
Apr 2017
CompletionActual
Apr 2017
Last update
May 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02949154
Responsible party
Sponsor
First posted
Oct 31, 2016
Start date
Nov 2016
Primary completion
Apr 2017
Completion
Apr 2017
Last update
May 6, 2024

Study contacts

M. Jalving, MD, PhD
principal investigator · University Medical Center Groningen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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