MelanomaNCT00406900
Melanoma Inhibitory Activity (MIA): A Serological Marker for Metastatic Uveal Melanoma
An observational study of Melanoma and Radiotherapy, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma, Radiotherapy, Metastatic Disease
- What is being tested?
- Treatment of metastatic disease
- Type of treatment
- Surgery or procedure
- How many people
- 560 participants
- Where
- 1 siteGermany
- Study dates
- Jan 1999to Sep 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- uveal melanoma (With/without overt metastatic disease)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dept of Ophthalmology, University of Munich
Munich, 80538
Ulrich C Schaller, MD, +49895160 ext. 3811, ulrich.schaller@med.uni-muenchen.de
Ulrich C Schaller, MD
About this study
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
Read the 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.
- Conditions
- Melanoma, Radiotherapy, Metastatic Disease
- Being tested
- Treatment of metastatic disease
- Keywords
- uveal melanoma, metastatic disease
- Medical subject headings
- Melanoma, Neoplasm Metastasis, Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of metastatic diseaseProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startJan 1999
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 560 participants
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Ulrich C Schaller, MD, Principal investigator, University of Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406900
- Sponsor's protocol ID
- MIA
- Status last verified
- Nov 2006
- First submitted
- 29 Nov 2006
- Last updated
- 6 Dec 2006
- Results posted
- No
Publications
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.
PubMed 12459649
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanoma Inhibitory Activity (MIA): A Serological Marker for Metastatic Uveal Melanoma
- ClinicalTrials.gov ID
- NCT00406900
- Acronym / sponsor ID
- MIA
- Conditions
- Melanoma, Radiotherapy, Metastatic Disease
- Keywords
- uveal melanoma, metastatic disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 560 participants
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Jan 1999
- Study completion
- Sep 2006
- First posted
- 4 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- uveal melanoma (With/without overt metastatic disease)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of metastatic disease | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2006.
- Results publication: PubMed 12459649Schaller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich C Schaller, MD principal investigator
University of Munich, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Radiotherapy, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrich C Schaller, MD (+49/89/5160 ext. 3811, ulrich.schaller@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00406900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2006.