Ocular Adnexal Mucosa-Associated Lymphoid Tissue LymphomaNCT01302912
Lymphoma in the Orbit
An observational study of Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma, run by University of Zurich at 1 site in Switzerland.
Trial summary
Imaging techniques have considerably improved over the last decades and ocular adnexal lymphomas (OALs) nowadays can be detected. As major advances in immunophenotyping and molecular diagnostics in histology have been achieved offering an accurate diagnosis, the investigators would like to introduce that surgical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma
- What is being tested?
- Lymphoma-Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2011to May 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient, who underwent biopsy of an ocular adnexal lymphoma between 01/2006 and 12/2010 at the University Hospital Zurich, Division of Ophthalmology
Who may be able to join
- >17 years of age
- underwent biopsy of an ocular adnexal lymphoma between 01/2006 and 12/2010 at the University Hospital Zurich, Division of Ophthalmology
- diagnosis histologically proven
Who cannot join
- less than 18 years of age
- patient underwent no MRI before surgery (biopsy)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Ophthalmic Clinic
Zurich, Canton of Zurich, 8091
About this study
Imaging techniques have considerably improved over the last decades and ocular adnexal lymphomas (OALs) nowadays can be detected. As major advances in immunophenotyping and molecular diagnostics in histology have been achieved offering an accurate diagnosis, the investigators would like to introduce that surgical biopsy of an orbital lymphoma becomes crucial for the possibility of a correct diagnosis and proper treatment. As radiotherapy accomplished great preciseness as well and OALs respond excellently to radiation, this therapy should be the treatment of choice in local defined lymphomas instead of blind treatment with steroids. Radiation results in great local control rates of 85% to 100%
- Trial with surgical intervention
- Being tested
- Lymphoma-Biopsy
- Keywords
- ocular adnexal lymphomas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphoma-BiopsyProcedure or surgery
Patients after biopsy of orbital lymphoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startFeb 2011
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Adnexal Mucosa-Associated Lymphoid Tissue LymphomaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karla Chaloupka, MD, Principal investigator, University Hospital Zurich, Ophtalmic Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302912
- Sponsor's protocol ID
- USZ-OALs-Register
- Status last verified
- Nov 2011
- First submitted
- 23 Feb 2011
- Last updated
- 4 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphoma in the Orbit
- ClinicalTrials.gov ID
- NCT01302912
- Acronym / sponsor ID
- USZ-OALs-Register
- Keywords
- ocular adnexal lymphomas
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2011
- Study completion
- May 2012 (estimated)
- First posted
- 24 Feb 2011 (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.
Imaging techniques have considerably improved over the last decades and ocular adnexal lymphomas (OALs) nowadays can be detected. As major advances in immunophenotyping and molecular diagnostics in histology have been achieved offering an accurate diagnosis, the investigators would like to introduce that surgical biopsy of an orbital lymphoma becomes crucial for the possibility of a correct diagnosis and proper treatment. As radiotherapy accomplished great preciseness as well and OALs respond excellently to radiation, this therapy should be the treatment of choice in local defined lymphomas instead of blind treatment with steroids. Radiation results in great local control rates of 85% to 100%
- Trial with surgical intervention
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient, who underwent biopsy of an ocular adnexal lymphoma between 01/2006 and 12/2010 at the University Hospital Zurich, Division of Ophthalmology
Key inclusion criteria (3 listed)
- >17 years of age
- underwent biopsy of an ocular adnexal lymphoma between 01/2006 and 12/2010 at the University Hospital Zurich, Division of Ophthalmology
- diagnosis histologically proven
Key exclusion criteria (2 listed)
- less than 18 years of age
- patient underwent no MRI before surgery (biopsy)
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 |
|---|---|---|
| Lymphoma-BiopsyPatients after biopsy of orbital lymphoma | 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 4 Nov 2011.
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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.
Karla Chaloupka, MD principal investigator
University Hospital Zurich, Ophtalmic Clinic
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 Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 2 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 4 Nov 2011. 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 Switzerland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 4 Nov 2011.