NCT02907827

Brief Summary

Patients with locally advanced melanoma are at high risk for recurrence following surgical treatment. More patients with stage IV melanoma remain in complete remission following systemic therapy. No standards have been established for the surveillance of patients at high risk for recurrence. Whole-body diffusion-weighted magnetic resonance imaging and cfDNA analysis of blood are innovative imaging and laboratory investigations that may be of benefit for early detection of recurrence in this patient population.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

November 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

11 years

First QC Date

September 14, 2016

Last Update Submit

December 16, 2020

Conditions

Melanoma

Keywords

complete remissioncfDNADW-MRIsurveillance

Outcome Measures

Primary Outcomes (1)

  • explorative evaluation of the use of DWMRI in the follow-up of high risk melanoma patients

    5years

Secondary Outcomes (3)

  • • Distant metastasis-free survival (for stage III patients only), overall survival

    5years

  • • Registration of the nature and result of salvage therapies offered at the time of detection of recurrence/progression

    5 years

  • • Explore the correlation of cfDNA measurements and the clinical or MRI based diagnosis of recurrence/progression

    5years

Study Arms (2)

stage IV melanoma CR>3years

EXPERIMENTAL

Stage IV: Complete remission for more than 3 years, confirmed by most recent CT or PET-CT imaging

Other: follow up DW MRI

Stage III Melanoma

EXPERIMENTAL

AJCC Stage III: No evidence of disease on most recent CT or PET-CT imaging

Other: follow up DW MRI

Interventions

follow up DW MRIOTHER

Whole-body diffusion-weighted magnetic resonance imaging and cfDNA analysis

Also known as: cfDNA
Stage III Melanomastage IV melanoma CR>3years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed malignant melanoma;
  • AJCC Stage III: No evidence of disease on most recent CT or PET-CT imaging
  • Stage IV: Complete remission for more than 3 years, confirmed by most recent CT or PET-CT imaging

You may not qualify if:

  • Contra-indication for MRI: pacemaker, metallic foreign body in eye, recent operation with prosthetic material (\< 6weken)
  • Claustrophobia
  • Metallic devices implanted such as hip prostheses, since this can alter the imaging quality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UZ Brussel

Jette, Brabant, 1090, Belgium

RECRUITING

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

MelanomaPathologic Complete Response

Interventions

Cell-Free Nucleic Acids

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesDisease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nucleic AcidsNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Bart Neyns, Md Phd

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bart Neyns, MD Phd

CONTACT

02 477 60 40bart.neyns@uzbrussel.be

Yanina JL Jansen, MD

CONTACT

02 477 91 23yanina.jansen@uzbrussel.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 20, 2016

Study Start

November 1, 2014

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

anonymous

Locations

BE(2)