NCT01924923

Brief Summary

This pilot study intends to investigate a new biopsy technique that will decrease the incidence of tumor cells in the biopsy tract.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

August 13, 2013

Last Update Submit

March 25, 2015

Conditions

Uveal Melanoma

Keywords

uveal melanomabiopsyenucleationocular cancer

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with melanotic cells present at biopsy needle site

    1 Year

Study Arms (1)

Uveal Melanoma

Scheduled for enucleation surgery

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 21, diagnosed with uveal melanoma and scheduled to undergo enucleation surgery. No known metastatis.

You may qualify if:

  • Diagnosed with uveal melanoma
  • Scheduled for enucleation surgery

You may not qualify if:

  • Patients under 21 years old
  • Patients unable to undergo surgery
  • Patients with known metastatic uveal melanoma or other cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Related Publications (11)

  • 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.

    PMID: 9744369BACKGROUND

  • The 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.

    PMID: 9645716BACKGROUND

  • Schyberg 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.

    PMID: 184645BACKGROUND

  • Jakobiec 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.

    PMID: 551354BACKGROUND

  • Caminal 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.

    PMID: 16606890BACKGROUND

  • Glasgow 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.

    PMID: 3369520BACKGROUND

  • Karcioglu 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.

    PMID: 4088631BACKGROUND

  • Engzell 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.

    PMID: 4329702BACKGROUND

  • SNELL 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.

    PMID: 14829489BACKGROUND

  • Shields 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.

    PMID: 8233394BACKGROUND

  • Schefler 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.

    PMID: 24030334BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

The eye will be enucleated and histopathologic sections of the sclera will be examined for extra scleral extension of cells. After the tissues are examined, they will be stored in the ocular histopathology lab for 10 years.

MeSH Terms

Conditions

Uveal MelanomaEye Neoplasms

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsNeoplasms by SiteEye DiseasesUveal Diseases

Study Officials

  • Amy C. Schefler, MD

    Retina Consultants Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Ophthalmic Oncology

Study Record Dates

First Submitted

August 13, 2013

First Posted

August 19, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

US(1)