NCT02668887

Brief Summary

Within the first year after diagnosis, data on employment and quality of life will be collected and evaluated in patients with malignant melanoma

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Typical duration 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

January 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

2.3 years

First QC Date

January 27, 2016

Last Update Submit

February 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of life questionnaire

    one year

Interventions

Eligibility Criteria

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

Patients with malignant melanoma

You may qualify if:

  • first diagnosis of malignant melanoma stage 0 to stage IIIC within the last 6 weeks
  • written informed consent

You may not qualify if:

  • diagnosis of malignant melanoma stage IV
  • inability to follow the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fachklinik Hornheide

Münster, 48157, Germany

Location

MeSH Terms

Conditions

Melanoma

Interventions

Quality of Life

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

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Hans-Joachim Schulze, M.D.

    Fachklinik Hornheide

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 27, 2016

First Posted

January 29, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2018

Study Completion

February 1, 2019

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations