Immuno-monitoring of Patients With Metastatic Melanoma (A... | NCT02332642

Studies
Immuno-monitoring of Patients With Metastatic Melanoma (AJCC Stadium IV) Under Chemotherapy

NCT02332642

Sponsor

Universitätsmedizin Mannheim

Status

Completed

Last Update Posted

Mar 7, 2017Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Immuno-monitoring

Interventions

Immuno-monitoring

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 31, 2016Actual

First Submitted Date

Jan 5, 2015

First Submission Date that Met QC Criteria

Jan 6, 2015

First Posted Date

Jan 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2017

Last Update Posted Date

Mar 7, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Christoffer Gebhardt, Principal Investigator, Universitätsmedizin MannheimPrincipal Investigator

Lead Sponsor

Universitätsmedizin MannheimOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This pilot clinical trial aims at evaluating immuno-modulating effects of palliative treatment with specifically dosed standard chemotherapeutics in patients with metastatic melanoma (AJCC stage IV) by assessing myeloid-derived suppressor cells' (MDSCs) count and activity.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Name	Type	Description	Arm Group Labels	Other Names
Immuno-monitoring	Other

Measure	Description	Time Frame
Immuno-monitoring		Immediate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

histologically defined metastatic melanoma patients (AJCC stage IV)
aged 18 to 80 years
at least one prior systemic anti-melanoma therapy; if BRAFV600 positive, at least one prior BRAFi therapy

Exclusion Criteria:

therapy-naive patients
any contra-indications for (specific) systemic chemotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Metastatic melanoma patients (AJCC stage IV)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christoffer Gebhardt, M.D.	Universitätsmedizin Mannheim	Principal Investigator
Jochen Utikal, M.D.	Universitätsmedizin Mannheim	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsmedizin Mannheim, Klinik für Dermatologie, Venerologie und Allergologie		Mannheim		68167	Germany