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Publications of the COMS
COMS Protocol and Data Collection Forms
Copies of the COMS Manual of Procedures and Study Forms book may be
obtained from:
National Technical Information Service (NTIS)
U.S. Department of Commerce
5285 Port Royal Road
Springfield, Virginia 22161
USA
Specify the title and NTIS accession number when ordering.
- PB95-179693INZ: Collaborative Ocular Melanoma Study Manual of Procedures
- PB98-139629: Collaborative Ocular Melamona Study Forms Book
COMS Numbered Reports
-
Collaborative Ocular Melanoma Study Group: Accuracy of diagnosis
of choroidal melanomas in the Collaborative Ocular Melanoma Study. COMS
Report No. 1. Arch Ophthalmol 108:1268-1273, 1990.
- Collaborative Ocular Melanoma Study Group: Complications of
enucleation surgery. COMS Report No. 2. In: Proceedings of the
Symposium on Retina and Vitreous (Rudolph M. Franklin, ed.).
New Orleans Academy of Ophthalmology. Kugler Publications, New York,
1993; pp. 181-190.
- Collaborative Ocular Melanoma Study Group: Design and methods
of a clinical trial for a rare condition: The Collaborative Ocular
Melanoma Study. COMS Report No. 3. Controlled Clin Trials
14:362-391, 1993.
-
Collaborative Ocular Melanoma Study Group: Mortality in patients
with small choroidal melanoma. COMS Report No. 4.
Arch Ophthalmol 115:886-893, 1997.
- Collaborative Ocular Melanoma Study Group: Factors predictive of growth
and treatment of small choroidal melanoma. COMS Report No. 5.
Arch Ophthalmol 115:1537-1544, 1997.
-
Collaborative Ocular Melanoma Study Group: Histopathologic
characteristics of uveal melanomas in eyes enucleated from the Collaborative Ocular Melanoma
Study. COMS Report No. 6. Am J Ophthalmol 125:745-766, 1998.
- Collaborative Ocular Melanoma Study Group: Sociodemographic and
clinical predictors of participation in two randomized trials: Findings
from the Collaborative Ocular Melanoma Study. COMS Report No. 7.
Controlled Clin Trials 22:526-537, 2001.
- Grossniklaus HE, Albert DM, Green WR, Conway BP, Hovland KR for the
Collaborative Ocular Melanoma Study Group: Clear cell differentiation in
choroidal melanoma. COMS Report No. 8. Arch Ophthalmol 115:894-898, 1997.
- Collaborative
Ocular Melanoma Study Group: The Collaborative Ocular Melanoma Study
(COMS) randomized trial of pre-enucleation radiation of large choroidal
melanoma. I: Characteristics of patients enrolled and not enrolled.
COMS Report No. 9. Am J Ophthalmol 125:767-778,1998.
- Collaborative
Ocular Melanoma Study Group: 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 125:779-796,1998.
- Collaborative
Ocular Melanoma Study Group: 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 126:362-372, 1998.
- Collaborative Ocular Melanoma Study Group: Echography (ultrasound)
procedures for the Collaborative Ocular Melanoma Study. COMS Report No.
12. J Ophth Nurs Technol Part I, 18(4):143-149, Part II,
18(5):219-232, 1999.
- Collaborative Ocular Melanoma Study Group: Consistency of observations from echograms made centrally in the Collaborative Ocular Melanoma Study.
COMS Report No. 13. Ophthalmic Epidemiol 9:11-27, 2002.
- Collaborative Ocular Melanoma Study Group:
Cause-specific mortality coding: Methods in the Collaborative Ocular
Melanoma Study. COMS Report No. 14. Control Clin Trials 22: 248-262, 2001.
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Collaborative Ocular Melanoma Study Group: Assessment
of metastatic disease status at death in 435 patients with large
choroidal melanoma in the Collaborative Ocular Melanoma Study. COMS
Report No. 15. Arch Ophthalmol 119:670-676, 2001.
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Collaborative Ocular Melanoma Study Group: Collaborative Ocular Melanoma Study (COMS)
randomized trial of I-125 brachytherapy for medium choroidal melanoma.
I. Visual acuity after 3 years. COMS Report No. 16. Ophthalmology 108(2):348-366,
2001.
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Collaborative Ocular Melanoma Study Group: The COMS randomized trial of iodine 125
brachytherapy for choroidal melanoma. II. Characteristics of patients enrolled and not
enrolled. COMS Report No. 17. Arch Ophthalmol 119: 951-965, 2001.
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Collaborative Ocular Melanoma Study Group: The COMS randomized
trial of iodine 125 brachytherapy for choroidal melanoma. III. Initial mortality findings.
COMS Report No. 18. Arch Ophthalmol 119: 969-982, 2001.
- Collaborative Ocular Melanoma Study Group: The COMS
randomized trial of iodine 125 brachytherapy for choroidal melanoma.
Local treatment failure and enucleation in the first 5 years after
brachytherapy. COMS Report No. 19. Ophthalmology 198:2197-2206, 2002.
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Collaborative Ocular Melanoma Study Group: Trends in
size and treatment of recently diagnosed choroidal melanoma, 1987-1997.
Findings from patients evaluated at Collaborative Ocular Melanoma Study
centers. COMS Report No. 20. Arch Ophthalmol 121:1156-1162, 2003.
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Collaborative Ocular Melanoma Study Group: Comparison
of clinical, echographic, and histologic measurements from eyes with
medium-sized choroidal melanoma in the Collaborative Ocular Melanoma
Study. COMS Report No. 21. Arch Opthalmol 121:1163-1171, 2003.
- Collaborative Ocular Melanoma Study Group: Ten-year
follow-up of fellow eyes of patients enrolled in Collaborative Ocular
Melanoma Study (COMS) randomized trials. COMS Report No. 22. Ophthalmology
111:996-976, 2004.
- Diener-West M, Reynolds SM, Agugliaro DJ, Caldwell R, Cumming K, Earle JD, Green
DL, Hawkins BS, Hayman I, Jaiyesimi I, Kirkwood JM, Koh W-J, Robertson DM,
Shaw JM, Thoma J. Screening for metastasis from choroidal melanoma:
Experience of the Collaborative Ocular Melanoma Study. Collaborative Ocular
Melanoma Study Report No. 23. Am J Clin Oncol 22:2438-2444, 2004.
- Collaborative Ocular Melanoma Study Group: The Collaborative Ocular Melanoma
Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma. IV. Ten-year mortality findings and prognostic factors. COMS Report
No. 24. Am J Ophthalmol 138:936-951, 2004.
- Collaborative Ocular Melanoma Study Group: Second Primary
Cancers After Enrollment in the COMS Trials for Treatment of Choroidal
Melanoma. COMS Report No. 25. Arch Ophthalmol 123:601-604, 2005.
- Collaborative Ocular Melanoma Study Group. Development of metastatic
disease after enrollment in the COMS trials for treatment of choroidal
melanoma. Collaborative Ocular Melanoma Study Group Report No. 26.Arch Ophthalmol 123:1639-1643, 2005.
- Collaborative Ocular Melanoma Study Group. Incidence of cataract and
outcomes after cataract surgery in the first 5 years after
125I brachytherapy in the COMS. COMS Report No. 27.
Ophthalmology 2007.
- Collaborative Ocular Melanoma Study Group. The COMS randomized trial
of iodine 125 brachytherapy for choroidal melanoma. V. Twelve-year mortality
rates and prognostic factors. COMS Report No. 28. Arch Ophthalmol
124:1684-1693, 2006.
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COMS-QOLS Reports
- Melia BM, Moy CS, McCaffrey L: Quality of life in patients with
choroidal melanoma: A pilot study. Ophthalmic Epidemiol 6:19-28, 1999.
- COMS Quality of Life Study Group: Quality of life assessment
in the Collaborative Ocular Melanoma Study: Design and methods. COMS-QOLS
Report No. 1. Ophthalmic Epidemiol 6:5-17, 1999.
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COMS Quality of Life Study Group: Development and validation of disease-specific
measures for choroidal melanoma. COMS-QOLS Report No. 2.
Arch Ophthalmol121:1010-1020, 2003.
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Collaborative Ocular Melanoma Study -- Quality of Life Study Group. Quality
of life after iodine 125 brachytherapy versus enucleation for choroidal
melanoma: 5-year results from the Collaborative Ocular Melanoma Study
prospective study. COMS-QOLS Report No. 3. Arch Ophthalmol
124:226-238, 2006.
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Editorials, Letters, Other Journal Articles, Proceedings, Other
- Fine SL: How should we manage a patient with uveal melanoma?
[Editorial] Arch Ophthalmol 103:910-911, 1985.
- Fine SL: Do I take the eye out or leave it in? [Editorial]
Arch Ophthalmol 104:653-654, 1986.
- Fine SL: Reply to comment on "Do I take the eye out or leave
it in?" [Letter] Arch Ophthalmol 104:1746-1747, 1986.
- Fine SL: The Collaborative Ocular Melanoma Study. Research
to Prevent Blindness, Inc. Science Writers Seminar; 1987.
- Earle J, Kline RW, Robertson DM: Selection of iodine 125 for
the Collaborative Ocular Melanoma Study. Arch Ophthalmol 105:763-764,
1987.
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Straatsma BR, Fine SL, Earle JD, Hawkins BS, Diener-West M, McLaughlin
JA, The Collaborative Ocular Melanoma Study Research Group: Enucleation
versus plaque irradiation for choroidal melanoma. Ophthalmology
95:1000-1004, 1988.
- Robertson DM: A rationale for comparing radiation to enucleation
in the management of choroidal melanoma. Am J Ophthalmol 108(4):448-451,
1989.
- Collaborative Ocular Melanoma Study Steering Committee: Response
to Char et al: "Failure of preenucleation radiation to decrease uveal
melanoma mortality" [Letter]. Am J Ophthalmol 107(4):440-441, 1989.
- Schachat AP, Markowitz JA, Hawkins BS, Fine SL, Collaborative
Ocular Melanoma Study Group: Nonocular cancers in patients with choroidal
melanoma. [Letter] Ophthalmology 97(7):837-838, 1990.
- Schachat AP: Collaborative Ocular Melanoma Study. Proceedings
of the Second International Meeting on the Diagnosis and Treatment
of Intraocular Tumors, Geneva, Switzerland, November 22-27, 1987.
- Park WL: The Collaborative [O]cular [M]elanoma [S]tudy. [Editorial]
J Am Optom Assoc 63(9):609-610, 1992.
- Ruiz RS, Diaz D: Collaborative Ocular Melanoma Study: Iodine-125
plaque therapy. Cancer Bull 44:360-365, 1992.
- Fine SL: Choroidal melanoma: A practical approach for the
1990's. In: Proceedings of the Symposium on Retina and Vitreous
(Rudolph M. Franklin, ed.). New Orleans Academy of Ophthalmology.
Kugler Publications, New York, 1993; pp. 191-192.
- Davis MD, Fine SL, Kupfer C: The Collaborative Ocular Melanoma
Study. [Letter] Arch Ophthalmol 112:730-731, 1994.
- Schachat AP for the Collaborative Ocular Melanoma Study Group:
Management of uveal melanoma. A continuing dilemma. [Letter] Cancer
74(11):3073-5, 1994.
- Kelly MP, Hahn KM: The Collaborative Ocular Melanoma Study.
J Ophthalmic Photog 17 (1):18-21, 1995.
- Wells C, Bradford RH, Fish GE, Straatsma BR, Hawkins BS for
the COMS Group: Choroidal melanoma in American Indians. Arch
Ophthalmol 114:1017-1018, 1996.
- Fine SL: No one knows the preferred management for choroidal
melanoma. Am J Ophthalmol 122:106-108, 1996.
- Goldsborough IL, Church RY, Newhouse MM, Hawkins BS: How clinic
coordinators spend their time in a multicenter clinical trial. Applied
Clin Trials 7(1):33-40, 1998.
- Scott IV, Moy CS, Murray TG for the COMS Group: Update
on the Collaborative Ocular Melanoma Study (COMS) for the Comprehensive
Ophthalmologist. J Comp Ophthalmol Update 1:185-191, 2000.
- Fine SL, Straatsma BR, Earle, JD, Davis MD: Reply to comment on "The COMS:
Why was it not stopped sooner?" [Letter] Ophthalmology 120:673, 2002.
- Diener-West M, Hawkins BS for the COMS Group: Changing
current practice: Implementing large multicenter trials for a rare
condition. Applied Clin Trials 11(9);48-54, 2002.
- Hollick RA, Reynolds SM for the COMS Group: Adding centers to boost subject
accrual: A case study for a rare condition. Applied Clin Trials 11(10):54-59, 2002.
- Mobley RY, Moy CS, Reynolds SM, Diener-West M, Newhouse MM,
Kerman JS, Hawkins BS. Time trends in personnel certification and turnover in
the Collaborative Ocular Melanoma Study. Clinical Trials 1(4):377-386,
2004.
- Fine SL, Hawkins BS. The investigators' perspective on the
Collaborative Ocular Melanoma Study. Arch Ophthalmol 2007 (in press).
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Published Abstracts (not superseded by other publications)
- Melia BM, Diener-West M, Collaborative Ocular Melanoma Study
Coordinating Center: Statistical methods for monitoring recruitment
in a multicenter clinical trial. Controlled Clin Trials 10(3):345,
1989.
- Connor PB, Newhouse MM, Grubb SC: Tracking, accessing and
reporting on edit queries. Controlled Clin Trials 11(4):272,
1990.
- Markowitz JA, Willis DM, Collaborative Ocular Melanoma Study
Research Group: Is standardization possible in a multicenter clinical
trial in which 45 medical centers and 500 clinical professionals are
involved? The COMS experience. Controlled Clin Trials 11(4):289,
1990.
- Hoover BA, Connor PB: Analyzing edit queries to identify problems
in data collection, edits, and management. Controlled Clin Trials
12(5):649, 1991.
- Moy CS for the COMS Quality Assurance Committee: Classification
of protocol deviations in a complex study. Controlled Clin Trials
13(5):390, 1992.
- Newhouse MM, Kerman JS for the COMS Coordinating Center:
Computer assisted eligibility review and randomization. Controlled
Clin Trials 13(5):400, 1992.
- Manos KS, Kerman JS for the COMS Coordinating Center: Computer-assisted
clinic monitoring: The COMS experience. Controlled Clin Trials
13(5):416, 1992.
- Coates TC, Connor PB for the COMS Coordinating Center: Lessons
for coordinating center management from a centralized computer-assisted
randomization system. Controlled Clin Trials 13(5):429, 1992.
- Moy CS for the COMS Group: Factors predictive of choice of
treatment among patients with choroidal melanoma. Invest Ophth
Vis Sci 34(4):967, 1993.
- Manos KS, Moy CS for the COMS Group: Phantom or real? Verification
of non-randomized patients evaluated for randomized clinical trials
of a rare disease. Controlled Clin Trials 14(5):441, 1993.
- Coates TC for the COMS Coordinating Center: Archiving and
material storage for a long-term clinical trial. Controlled Clin
Trials 14(5):448, 1993.
- Montague PR, Melia M, Weingeist TA and the COMS Study Group:
Evaluation of radiation retinopathy with color photography alone
vs. color photography with fluorescein angiography. Invest Ophthalmol
Vis Sci 35(4):1722, 1994.
- Coates TC, Hawkins BS for the COMS Group: (Un)Predictability
of accrual in randomized clinical trials. Controlled Clin Trials
16(3, suppl):83, 1995.
- Church RY, Kerman JS, Hawkins BS, Moy CS: Personnel certification
and turnover in the Collaborative Ocular Melanoma Study. Controlled
Clin Trials 17(2, suppl):76, 1996.
- Manos KS, Hollick RA for the COMS Group: Does workspace effect
coordinator performance in a randomized clinical trial? Controlled
Clin Trials 17(2, suppl):134, 1996.
- Kline R, Earle J: Implications of TG-43 for dose prescription
and calculation for I-125 eye plaques. Med Physics 23:1020,
1996.
- Hanson W: Implementation of the new I-125 standard and TG-43
recommendations in a cooperative clinical trial. Med Physics
23:1020, 1996.
- Imesch PD, Levitt BT, Albert DM for the COMS Group: Apoptosis
in intraocular and metastatic melanomas. Invest Ophthalmol Vis
Sci 39(4, suppl):414, 1998.
- Melia BM, Moy CM, Zeger SL for the COMS QOL Study:
Analysis of longitudinal quality of life data with incomplete and
possibly biased follow-up. Quality of Life Res 9(3):247, 2000.
- Hollick RA: Routine site visits in a multicenter clinical trial.
Controlled Clin Trials 24(3,suppl):185, 2003.
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Materials Filed at the National Technical Information Service
- Collaborative Ocular Melanoma Study Group: COMS Manual of Procedures,
PB95-179693, National Technical Information Service, Springfield,
VA, January 1995.
- Collaborative Ocular Melanoma Study Group: COMS Study Forms Book, PB98-139629,
National Technical Information Service, Springfield, VA, Aug 1998.
Return to the Index
Other COMS-related Articles in Peer-Reviewed Journals
- Marcus DM, Minkovitz JB, Wardwell SD, Albert DM for the Collaborative
Ocular Melanoma Study Group: The value of nucleolar organizer
regions in uveal melanoma. Am J Ophthalmol 110:527-534, 1990.
- Markowitz JA, Hawkins BS, Diener-West M, Schachat AP: Review
of mortality from choroidal melanoma. Part I. Quality of published
reports, 1966 through 1988. Arch Ophthalmol 110:239-244, 1992.
- Diener-West M, Hawkins BS, Markowitz JA, Schachat AP: Review
of mortality from choroidal melanoma. Part II: A meta-analysis of
five-year mortality rates following enucleation, 1966 through 1988.
Arch Ophthalmol 110:245-250,1992.
- Taylor KM: Integrating conflicting professional roles: Physician
participation in randomized clinical trials. Soc Sci Med 35(2):217-224,
1992.
- Taylor KM: Physician participation in a randomized clinical
trial for ocular melanoma. Ann Ophthalmol 24:337-344, 1992.
- Albert DM, Niffenegger AS, Willson JKV: Treatment of metastatic
uveal melanoma: Review and recommendations. Surv Ophthalmol
36(6):429-438, 1992.
- Soparker CN, O'Brien JM, Albert DM: Investigation of the role
of ras proto-oncogene point mutation in human uveal melanomas. Invest
Ophthalmol Vis Sci 34(7):2203-2209, 1993.
- Hawkins BS, McBride R, Singer SW, eds: Data Management for
Multicenter Studies: Methods and Guidelines. Controlled Clin Trials
16(2, suppl): 1-179, 1995. [This monograph includes several examples
from COMS data management systems to illustrate current standards.]
- Umlas J, Diener-West M, Robinson NL, Green WR, Grossnicklaus HE, Albert
DM: Comparison of transillumination and histologic slide measurements
of choroidal melanoma. Arch Ophthalmol 115(4):474-477, 1997.
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Diener-West M, Connor PB, Newhouse MM, Hawkins BS: Feasibility of keying data
from screen-displayed facsimile images in an ongoing trial: The Collaborative
Ocular Melanoma Study. Controlled Clin Trials 19(1):39-49, 1998.
- Ruiz RS, El-Harazi S, Albert DM, Bryar PJ: Cardiac metastasis of choroidal melanoma. Arch Ophthalmol 117:1558-1559, 1999.
- Krintz AL, Hanson WF, Ibbott GS, Followill DS: A
reanalysis of the Collaborative Ocular Melanoma Study medium tumor
trial eye plaque dosimetry. Int J Rad Oncol Biol Phys 56:889-898, 2003.
- Straatsma BR,
Diener-West M, Caldwell R, Engstrom RE for the Collaborative Ocular Melanoma Study Group:
Mortality after deferral of treatment or no treatment for choroidal melanoma. Am J Ophthalmol 136:47-54, 2003.
- Nag S, Quivey JM, Earle JD, Followill D, Fontanesi J, Finger PT; American
Brachytherapy Society. The American Brachytherapy Society recommendations for
brachytherapy of uveal melanomas. Int J Radiat oncol Biol Phys. 56(2):544-55, 2003 Jun 1.
Return to the Index
Book Chapters
- Sahel JA, Earle JD, Albert DM: Intraocular melanomas, Chapter 47, In: De Vita, Jr.,
VT, Hellman S, Rosenberg SA, eds: Cancer: Principles and Practice of Oncology,
4th Edition. J.B. Lippincott Co.; Philadelphia, 1993; pp. 1662-1678.
- Melia BM, Diener-West M.: Modeling interrater agreement
on an ordered categorical scale. In: Lange N, Ryan L, eds: Case
Studies in Biometry, John Wiley and Sons, New York, 1994; pp. 323-338.
- Servodidio C, Abramson D: Collaborative Ocular Melnaoma Study. (Chapter 15) In: Kertes PJ, Conway MD, eds: Clinical Trials in Ophthalmology: A Summary and Practice Guide. Williams & Wilkins, Baltimore, 1998; pp. 257-270.
- Schachat AP: Clinical Trials and Future Considerations. Volume IV,
In: Boyd B, eds: World Atlas Series of Ophthalmic Surgery. Vol. IV.
Highlights of Ophthalmology, Inc.; Panama City, 1998; pp. 245-247.
- Seddon JM, Moy CS: Epidemiology of uveal melanoma. Chapter 35,
In: Ryan SJ, ed: Retina, 3rd Edition. Mosby, Inc.; St. Louis, 2001;
pp. 664-672.
- Seddon JM, Moy CS: Choroidal melanoma: Prognosis. Chapter 37,
In: Ryan SJ, ed: Retina, 3rd Edition. Mosby, Inc.; St. Louis, 2001;
pp. 687-699.
- Schachat AP, Hawkins BS: Collaborative Ocular Melanoma Study.
Chapter 44; In: Ryan SJ, ed: Retina, 4th Edition. Elsevier Mosby;
Philadelphia, 2005; pp. 803-810.
- Robertson DM, Earle JD, Kline RW: Brachytherapy for choroidal melanoma.
Chapter 38, In: Ryan SJ, ed: Retina, 4th Edition. Elsevier Mosby;
Philadelphia, 2005; pp. 747-759.
- Hawkins BS, Schachat AP. Collaborative Ocular Melanoma Study. Chapter
44; In: Ryan SJ, ed: Retina, 4th Edition. Elsevier: New York, 2006;
pp. 803-810.
- Robertson DM, Earle JD, Kline RW. Brachytherapy for choroidal melanoma.
Chapter 38, In: Ryan SJ, ed: Retina, 4th Edition. Elsevier: New York,
2006; pp. 747-759.
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The Collaborative Ocular Melanoma Study.
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