Melanoma Inhibitory Activity (MIA): A Serological Marker... | NCT00406900

Studies
Melanoma Inhibitory Activity (MIA): A Serological Marker for Metastatic Uveal Melanoma

NCT00406900

Sponsor

Ludwig-Maximilians - University of Munich

Status

Unknown status

Last Update Posted

Dec 6, 2006Estimated

Enrollment

560

Phase

Not provided

Conditions

Melanoma
Radiotherapy
Metastatic Disease

Interventions

Treatment of metastatic disease

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

Nov 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1999

Primary Completion Date

Not provided

Completion Date

Sep 2006

First Submitted Date

Nov 29, 2006

First Submission Date that Met QC Criteria

Nov 29, 2006

First Posted Date

Dec 4, 2006Estimated

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

Dec 5, 2006

Last Update Posted Date

Dec 6, 2006Estimated

Description Module

Brief Summary

Uveal Melanoma is the most common primary intraocular tumor in adults. Most tumors metastasize to the liver. So far no sensitive or specific serological tumor marker is routinely used. The marker "Melanoma inhibitory activity" is a promising marker. Study hypothesis is to detect metastatic lesions in an early stage. This would increase life expectance of our patients

Detailed Description

Serum is taken from each melanoma patient at every follow up after signed concent. With ELISA the marker MIA is evaluated. An increase of MIA serum level will lead to search for metastasis by oncologists.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

560

Name	Type	Description	Arm Group Labels	Other Names
Treatment of metastatic disease	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

uveal melanoma (With/without overt metastatic disease)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ulrich C Schaller, MD	Contact	+49/89/5160	3811	ulrich.schaller@med.uni-muenchen.de

Overall Officials

Name	Affiliation	Role
Ulrich C Schaller, MD	University of Munich, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Ophthalmology, University of Munich	Recruiting	Munich		80538	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12459649	Result	Schaller UC, Bosserhoff AK, Neubauer AS, Buettner R, Kampik A, Mueller AJ. Melanoma inhibitory activity: a novel serum marker for uveal melanoma. Melanoma Res. 2002 Dec;12(6):593-9. doi: 10.1097/01.cmr.0000043146.28051.b8.

ID	Term
D008545	Melanoma
D009362	Neoplasm Metastasis
D000098943	Uveal Melanoma

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type