Uveal MelanomaNCT01924923
New Biopsy Technique for Uveal Melanoma
An observational study of Uveal Melanoma, run by Greater Houston Retina Research at 1 site in United States.
Trial summary
This pilot study intends to investigate a new biopsy technique that will decrease the incidence of tumor cells in the biopsy tract. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Uveal Melanoma
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Mar 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 21, diagnosed with uveal melanoma and scheduled to undergo enucleation surgery. No known metastatis.
Who may be able to join
- Diagnosed with uveal melanoma
- Scheduled for enucleation surgery
Who cannot join
- Patients under 21 years old
- Patients unable to undergo surgery
- Patients with known metastatic uveal melanoma or other cancer.
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study intends to investigate a new biopsy technique that will decrease the incidence of tumor cells in the biopsy tract.
Read the detailed description
Uveal melanoma is the most common primary malignancy of the eye and is one of the few fatal diseases that are detected initially through an eye examination. For many years, clinical decision-making regarding which patient with uveal melanoma required treatment has been based solely on clinical features observed at the time of diagnosis. These features include: tumor size as measured by ultrasound, associated subretinal fluid, presence of orange lipofuscin pigment, lack of drusen, posterior location, and ciliary body involvement. All of these clinical features have been demonstrated to be associated with tumor growth which is associated with the eventual development of metastases. However, these clinical features are not adequately sensitive or specific enough to predict which patients will develop metastases.
More recently, researchers studying the genomics of uveal melanoma have focused on identifying genetic abnormalities present in tumor tissue in order to characterize these lesions more fully. Several landmark papers over the past 15 years have reported cytogenic and genomic abnormalities in uveal melanoma tumor tissue that are associated with a poorer prognosis. Although rare, there have been at least five cases in which patients undergoing biopsy of these lesions have developed extraocular spread of melanoma from the biopsy sites. With this new technique, the possible rate of extraocular spread should be lower, making the biopsy a safer technique than what is currently in practice.
- Conditions
- Uveal Melanoma
- Keywords
- uveal melanoma, biopsy, enucleation, ocular cancer
- Medical subject headings
- Uveal Melanoma, Eye Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Uveal Melanoma | Scheduled for enucleation surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with melanotic cells present at biopsy needle site
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Uveal 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greater Houston Retina Research
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Amy C Schefler, MD, Greater Houston Retina Research
- Investigators
- Amy C. Schefler, MD, Principal investigator, Retina Consultants Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924923
- Sponsor's protocol ID
- NBT-01
- Status last verified
- Mar 2015
- First submitted
- 13 Aug 2013
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma III: local complications and observations following enucleation COMS report no. 11. Am J Ophthalmol. 1998 Sep;126(3):362-72. doi: 10.1016/s0002-9394(98)00091-9.
PubMed 9744369The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma II: initial mortality findings. COMS report no. 10. Am J Ophthalmol. 1998 Jun;125(6):779-96. doi: 10.1016/s0002-9394(98)00039-7.
PubMed 9645716Schyberg E. Fine needle biopsy of orbital tumours [proceedings]. Acta Ophthalmol Suppl. 1975;(125):11. doi: 10.1111/j.1755-3768.1975.tb01202.x. No abstract available.
PubMed 184645Jakobiec FA, Coleman DJ, Chattock A, Smith M. Ultrasonically guided needle biopsy and cytologic diagnosis of solid intraocular tumors. Ophthalmology. 1979 Sep;86(9):1662-81. doi: 10.1016/s0161-6420(79)35349-0.
PubMed 551354Caminal JM, Sanz S, Carreras M, Catala I, Arruga J, Roca G. Epibulbar seeding at the site of a transvitreal fine-needle aspiration biopsy. Arch Ophthalmol. 2006 Apr;124(4):587-9. doi: 10.1001/archopht.124.4.587. No abstract available.
PubMed 16606890Glasgow BJ, Brown HH, Zargoza AM, Foos RY. Quantitation of tumor seeding from fine needle aspiration of ocular melanomas. Am J Ophthalmol. 1988 May 15;105(5):538-46. doi: 10.1016/0002-9394(88)90248-6.
PubMed 3369520Karcioglu ZA, Gordon RA, Karcioglu GL. Tumor seeding in ocular fine needle aspiration biopsy. Ophthalmology. 1985 Dec;92(12):1763-7. doi: 10.1016/s0161-6420(85)34105-2.
PubMed 4088631Engzell U, Esposti PL, Rubio C, Sigurdson A, Zajicek J. Investigation on tumour spread in connection with aspiration biopsy. Acta Radiol Ther Phys Biol. 1971 Aug;10(4):385-98. doi: 10.3109/02841867109130784. No abstract available.
PubMed 4329702SNELL AC Jr. Heterotransplantation of tumors into various regions of the guinea-pig eye. Am J Ophthalmol. 1951 May;34(5 1):733-8. doi: 10.1016/0002-9394(51)92285-4. No abstract available.
PubMed 14829489Shields JA, Shields CL, Ehya H, Eagle RC Jr, De Potter P. Fine-needle aspiration biopsy of suspected intraocular tumors. The 1992 Urwick Lecture. Ophthalmology. 1993 Nov;100(11):1677-84. doi: 10.1016/s0161-6420(93)31418-1.
PubMed 8233394Schefler AC, Gologorsky D, Marr BP, Shields CL, Zeolite I, Abramson DH. Extraocular extension of uveal melanoma after fine-needle aspiration, vitrectomy, and open biopsy. JAMA Ophthalmol. 2013 Sep;131(9):1220-4. doi: 10.1001/jamaophthalmol.2013.2506.
PubMed 24030334
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Biopsy Technique for Uveal Melanoma
- ClinicalTrials.gov ID
- NCT01924923
- Acronym / sponsor ID
- NBT-01
- Conditions
- Uveal Melanoma
- Keywords
- uveal melanoma, biopsy, enucleation, ocular cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Greater Houston Retina ResearchUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Study start
- Jun 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Aug 2013 (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 pilot study intends to investigate a new biopsy technique that will decrease the incidence of tumor cells in the biopsy tract.
Detailed description
Uveal melanoma is the most common primary malignancy of the eye and is one of the few fatal diseases that are detected initially through an eye examination. For many years, clinical decision-making regarding which patient with uveal melanoma required treatment has been based solely on clinical features observed at the time of diagnosis. These features include: tumor size as measured by ultrasound, associated subretinal fluid, presence of orange lipofuscin pigment, lack of drusen, posterior location, and ciliary body involvement. All of these clinical features have been demonstrated to be associated with tumor growth which is associated with the eventual development of metastases. However, these clinical features are not adequately sensitive or specific enough to predict which patients will develop metastases.
More recently, researchers studying the genomics of uveal melanoma have focused on identifying genetic abnormalities present in tumor tissue in order to characterize these lesions more fully. Several landmark papers over the past 15 years have reported cytogenic and genomic abnormalities in uveal melanoma tumor tissue that are associated with a poorer prognosis. Although rare, there have been at least five cases in which patients undergoing biopsy of these lesions have developed extraocular spread of melanoma from the biopsy sites. With this new technique, the possible rate of extraocular spread should be lower, making the biopsy a safer technique than what is currently in practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uveal Melanoma | – | –Scheduled for enucleation surgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 21, diagnosed with uveal melanoma and scheduled to undergo enucleation surgery. No known metastatis.
Key inclusion criteria (2 listed)
- Diagnosed with uveal melanoma
- Scheduled for enucleation surgery
Key exclusion criteria (3 listed)
- Patients under 21 years old
- Patients unable to undergo surgery
- Patients with known metastatic uveal melanoma or other cancer.
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
Number of subjects with melanotic cells present at biopsy needle site
Time frame: 1 Year
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 26 Mar 2015.
- Background: PubMed 9744369The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma III: local complications and observations following enucleation COMS report no. 11. Am J Ophthalmol. 1998 Sep;126(3):362-72. doi: 10.1016/s0002-9394(98)00091-9.
- Background: PubMed 9645716The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma II: initial mortality findings. COMS report no. 10. Am J Ophthalmol. 1998 Jun;125(6):779-96. doi: 10.1016/s0002-9394(98)00039-7.
- Background: PubMed 184645Schyberg E. Fine needle biopsy of orbital tumours [proceedings]. Acta Ophthalmol Suppl. 1975;(125):11. doi: 10.1111/j.1755-3768.1975.tb01202.x. No abstract available.
- Background: PubMed 551354Jakobiec FA, Coleman DJ, Chattock A, Smith M. Ultrasonically guided needle biopsy and cytologic diagnosis of solid intraocular tumors. Ophthalmology. 1979 Sep;86(9):1662-81. doi: 10.1016/s0161-6420(79)35349-0.
- Background: PubMed 16606890Caminal JM, Sanz S, Carreras M, Catala I, Arruga J, Roca G. Epibulbar seeding at the site of a transvitreal fine-needle aspiration biopsy. Arch Ophthalmol. 2006 Apr;124(4):587-9. doi: 10.1001/archopht.124.4.587. No abstract available.
- Background: PubMed 3369520Glasgow BJ, Brown HH, Zargoza AM, Foos RY. Quantitation of tumor seeding from fine needle aspiration of ocular melanomas. Am J Ophthalmol. 1988 May 15;105(5):538-46. doi: 10.1016/0002-9394(88)90248-6.
- Background: PubMed 4088631Karcioglu ZA, Gordon RA, Karcioglu GL. Tumor seeding in ocular fine needle aspiration biopsy. Ophthalmology. 1985 Dec;92(12):1763-7. doi: 10.1016/s0161-6420(85)34105-2.
- Background: PubMed 4329702Engzell U, Esposti PL, Rubio C, Sigurdson A, Zajicek J. Investigation on tumour spread in connection with aspiration biopsy. Acta Radiol Ther Phys Biol. 1971 Aug;10(4):385-98. doi: 10.3109/02841867109130784. No abstract available.
- Background: PubMed 14829489SNELL AC Jr. Heterotransplantation of tumors into various regions of the guinea-pig eye. Am J Ophthalmol. 1951 May;34(5 1):733-8. doi: 10.1016/0002-9394(51)92285-4. No abstract available.
- Background: PubMed 8233394Shields JA, Shields CL, Ehya H, Eagle RC Jr, De Potter P. Fine-needle aspiration biopsy of suspected intraocular tumors. The 1992 Urwick Lecture. Ophthalmology. 1993 Nov;100(11):1677-84. doi: 10.1016/s0161-6420(93)31418-1.
- Background: PubMed 24030334Schefler AC, Gologorsky D, Marr BP, Shields CL, Zeolite I, Abramson DH. Extraocular extension of uveal melanoma after fine-needle aspiration, vitrectomy, and open biopsy. JAMA Ophthalmol. 2013 Sep;131(9):1220-4. doi: 10.1001/jamaophthalmol.2013.2506.
Related trials for Uveal Melanoma
RecruitingObservational study
High-precision Radiosurgery Followed by Minimally Invasive Surgical Approach in Patients With High-prominence Uveal Melanoma: Modern Radiation Techniques and Outcomes
Uveal Melanoma, High-risk Uveal Melanoma
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
RecruitingPhase 2
HS-IT101 Injection Versus Chemotherapy in the Treatment of Advanced Melanoma（FASTIL-Mela02）
Melanoma (Excluding Uveal Melanoma)
Recruiting
Immune Response to Percutaneous Hepatic Perfusion With Melphalan for Ocular Melanoma Metastatic to the Liver
Uveal Melanoma
Active, not recruitingObservational study
Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
Choroidal Melanoma, Indeterminate Lesions
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.
Amy C. Schefler, MD principal investigator
Retina Consultants Houston
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 Uveal Melanoma, run by Greater Houston Retina Research 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 2 inclusion and 3 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 26 Mar 2015. 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?
Number of subjects with melanotic cells present at biopsy needle site (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01924923, which also lists 11 linked publications.
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 26 Mar 2015.