The Impact of Whole Body Irradiation on Ocular FlareNCT01640236
Flare Measurements in Human Radiation Therapy Patients
An observational study of The Impact of Whole Body Irradiation on Ocular Flare, run by ChromoLogic, LLC at 1 site in United States.
Trial summary
This is a longitudinal Feasibility Study of a novel non-invasive device in assessing radiation dose exposure in humans. All patients receiving whole body irradiation therapy and meeting all other inclusion/exclusion criteria will receive ocular flare meter measurements and slit-lamp examinations on up to eleven… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Impact of Whole Body Irradiation on Ocular Flare
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2014
- 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: All patients meeting the inclusion/exclusion criteria and receiving whole body irradiation at the UCLA Radiation Oncology clinic
Who may be able to join
- Subjects must be scheduled to receive whole body irradiation in a dose range from 1.5 to 12Gy.
- Subjects must not have received ocular surgery for at least three months prior to study enrolment.
- Subjects must not have a history of uveitis.
- Subjects must have at least one eye free of cataracts
- Subject age must be greater than 18 years
- Subjects must have the ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Inability to give informed consent
- Cataracts in both eyes
- Subject has received ocular surgery within the prior three months
- Subject has a history of uveitis
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Radiation Oncology
Los Angeles, California, 90095
About this study
This is a longitudinal Feasibility Study of a novel non-invasive device in assessing radiation dose exposure in humans. All patients receiving whole body irradiation therapy and meeting all other inclusion/exclusion criteria will receive ocular flare meter measurements and slit-lamp examinations on up to eleven occasions starting prior to the first fractional dose of irradiation.
- Keywords
- Ocular flare
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular flare in radiotherapy patients
Determine if ocular flare meter spectra and/or a slit-lamp eye exam can assess radiation dose exposure in individual human radiotherapy patients.
Measured: Daily measurements for the duration of radiotherapy treatment (expected up to four days from start of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Impact of Whole Body Irradiation on Ocular FlareStudies 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
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChromoLogic, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Michell Kamrava, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640236
- Sponsor's protocol ID
- OCDOS_PRO_110314_02
- Status last verified
- Jul 2014
- First submitted
- 10 Jul 2012
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flare Measurements in Human Radiation Therapy Patients
- ClinicalTrials.gov ID
- NCT01640236
- Acronym / sponsor ID
- OCDOS_PRO_110314_02
- Keywords
- Ocular flare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ChromoLogic, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Jul 2012 (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.
This is a longitudinal Feasibility Study of a novel non-invasive device in assessing radiation dose exposure in humans. All patients receiving whole body irradiation therapy and meeting all other inclusion/exclusion criteria will receive ocular flare meter measurements and slit-lamp examinations on up to eleven occasions starting prior to the first fractional dose of irradiation.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients meeting the inclusion/exclusion criteria and receiving whole body irradiation at the UCLA Radiation Oncology clinic
Key inclusion criteria (6 listed)
- Subjects must be scheduled to receive whole body irradiation in a dose range from 1.5 to 12Gy.
- Subjects must not have received ocular surgery for at least three months prior to study enrolment.
- Subjects must not have a history of uveitis.
- Subjects must have at least one eye free of cataracts
- Subject age must be greater than 18 years
Key exclusion criteria (4 listed)
- Inability to give informed consent
- Cataracts in both eyes
- Subject has received ocular surgery within the prior three months
- Subject has a history of uveitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ocular flare in radiotherapy patients
Time frame: Daily measurements for the duration of radiotherapy treatment (expected up to four days from start of treatment)
Determine if ocular flare meter spectra and/or a slit-lamp eye exam can assess radiation dose exposure in individual human radiotherapy patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
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.
Michell Kamrava, MD principal investigator
University of California, Los Angeles
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 The Impact of Whole Body Irradiation on Ocular Flare, run by ChromoLogic, LLC at 1 site in United States.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 15 Jul 2014. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Ocular flare in radiotherapy patients (time frame: Daily measurements for the duration of radiotherapy treatment (expected up to four days from start of treatment)). It is what the study was designed to measure, not a finding.
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 15 Jul 2014.