NCT02949154

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

October 27, 2016

Last Update Submit

May 3, 2024

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (5)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic melanoma

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • M. Jalving, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2016

First Posted

October 31, 2016

Study Start

November 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

May 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)