COMS

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

  1. 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.

  2. 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.

  3. 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.

  4. Collaborative Ocular Melanoma Study Group: Mortality in patients with small choroidal melanoma. COMS Report No. 4. Arch Ophthalmol 115:886-893, 1997.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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

  1. Melia BM, Moy CS, McCaffrey L: Quality of life in patients with choroidal melanoma: A pilot study. Ophthalmic Epidemiol 6:19-28, 1999.

  2. 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.

  3. 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.

  4. 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

  1. Fine SL: How should we manage a patient with uveal melanoma? [Editorial] Arch Ophthalmol 103:910-911, 1985.

  2. Fine SL: Do I take the eye out or leave it in? [Editorial] Arch Ophthalmol 104:653-654, 1986.

  3. Fine SL: Reply to comment on "Do I take the eye out or leave it in?" [Letter] Arch Ophthalmol 104:1746-1747, 1986.

  4. Fine SL: The Collaborative Ocular Melanoma Study. Research to Prevent Blindness, Inc. Science Writers Seminar; 1987.

  5. Earle J, Kline RW, Robertson DM: Selection of iodine 125 for the Collaborative Ocular Melanoma Study. Arch Ophthalmol 105:763-764, 1987.

  6. 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.

  7. Robertson DM: A rationale for comparing radiation to enucleation in the management of choroidal melanoma. Am J Ophthalmol 108(4):448-451, 1989.

  8. 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.

  9. 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.

  10. 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.

  11. Park WL: The Collaborative [O]cular [M]elanoma [S]tudy. [Editorial] J Am Optom Assoc 63(9):609-610, 1992.

  12. Ruiz RS, Diaz D: Collaborative Ocular Melanoma Study: Iodine-125 plaque therapy. Cancer Bull 44:360-365, 1992.

  13. 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.

  14. Davis MD, Fine SL, Kupfer C: The Collaborative Ocular Melanoma Study. [Letter] Arch Ophthalmol 112:730-731, 1994.

  15. Schachat AP for the Collaborative Ocular Melanoma Study Group: Management of uveal melanoma. A continuing dilemma. [Letter] Cancer 74(11):3073-5, 1994.

  16. Kelly MP, Hahn KM: The Collaborative Ocular Melanoma Study. J Ophthalmic Photog 17 (1):18-21, 1995.

  17. 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.

  18. Fine SL: No one knows the preferred management for choroidal melanoma. Am J Ophthalmol 122:106-108, 1996.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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)

  1. 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.

  2. Connor PB, Newhouse MM, Grubb SC: Tracking, accessing and reporting on edit queries. Controlled Clin Trials 11(4):272, 1990.

  3. 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.

  4. Hoover BA, Connor PB: Analyzing edit queries to identify problems in data collection, edits, and management. Controlled Clin Trials 12(5):649, 1991.

  5. Moy CS for the COMS Quality Assurance Committee: Classification of protocol deviations in a complex study. Controlled Clin Trials 13(5):390, 1992.

  6. Newhouse MM, Kerman JS for the COMS Coordinating Center: Computer assisted eligibility review and randomization. Controlled Clin Trials 13(5):400, 1992.

  7. Manos KS, Kerman JS for the COMS Coordinating Center: Computer-assisted clinic monitoring: The COMS experience. Controlled Clin Trials 13(5):416, 1992.

  8. 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.

  9. 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.

  10. 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.

  11. Coates TC for the COMS Coordinating Center: Archiving and material storage for a long-term clinical trial. Controlled Clin Trials 14(5):448, 1993.

  12. 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.

  13. Coates TC, Hawkins BS for the COMS Group: (Un)Predictability of accrual in randomized clinical trials. Controlled Clin Trials 16(3, suppl):83, 1995.

  14. 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.

  15. 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.

  16. Kline R, Earle J: Implications of TG-43 for dose prescription and calculation for I-125 eye plaques. Med Physics 23:1020, 1996.

  17. Hanson W: Implementation of the new I-125 standard and TG-43 recommendations in a cooperative clinical trial. Med Physics 23:1020, 1996.

  18. 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.

  19. 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.

  20. 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

  1. Collaborative Ocular Melanoma Study Group: COMS Manual of Procedures, PB95-179693, National Technical Information Service, Springfield, VA, January 1995.

  2. Collaborative Ocular Melanoma Study Group: COMS Study Forms Book, PB98-139629, National Technical Information Service, Springfield, VA, Aug 1998.

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Other COMS-related Articles in Peer-Reviewed Journals

  1. 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.

  2. 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.

  3. 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.

  4. Taylor KM: Integrating conflicting professional roles: Physician participation in randomized clinical trials. Soc Sci Med 35(2):217-224, 1992.

  5. Taylor KM: Physician participation in a randomized clinical trial for ocular melanoma. Ann Ophthalmol 24:337-344, 1992.

  6. Albert DM, Niffenegger AS, Willson JKV: Treatment of metastatic uveal melanoma: Review and recommendations. Surv Ophthalmol 36(6):429-438, 1992.

  7. 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.

  8. 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.]

  9. 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.

  10. 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.

  11. Ruiz RS, El-Harazi S, Albert DM, Bryar PJ: Cardiac metastasis of choroidal melanoma. Arch Ophthalmol 117:1558-1559, 1999.

  12. 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.

  13. 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.

  14. 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.

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Book Chapters

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Seddon JM, Moy CS: Choroidal melanoma: Prognosis. Chapter 37, In: Ryan SJ, ed: Retina, 3rd Edition. Mosby, Inc.; St. Louis, 2001; pp. 687-699.

  7. Schachat AP, Hawkins BS: Collaborative Ocular Melanoma Study. Chapter 44; In: Ryan SJ, ed: Retina, 4th Edition. Elsevier Mosby; Philadelphia, 2005; pp. 803-810.

  8. 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.

  9. Hawkins BS, Schachat AP. Collaborative Ocular Melanoma Study. Chapter 44; In: Ryan SJ, ed: Retina, 4th Edition. Elsevier: New York, 2006; pp. 803-810.

  10. 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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