COMS - Ancillary Studies

Pilot, Parallel and Ancillary Studies Currently Active or Completed

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PILOT STUDY FOR SMALL CHOROIDAL MELANOMA
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A nonrandomized prospective pilot study of small choroidal melanoma (i.e., those no more than 3.0 mm in apical height and no more than 16.0 mm in longest basal diameter) was initiated concurrently with COMS randomized trials of treatment for medium and large choroidal melanoma. The objectives of this pilot study were:

To determine the number of patients with small tumors presenting at COMS Clinical Centers or referred to them;
To determine how these small tumors were being managed by the ophthalmologic community as represented by the COMS investigators;
To observe the rate of growth of these small tumors over a short period of time;
To determine, in a limited way, the impact of these small tumors on survival, visual acuity, and metastatic disease;
To identify methods of management that were candidates for evaluation in a randomized controlled trial.

This group of cases may be the most important in terms of long-range management of choroidal melanoma as these tumors are diagnosed much earlier than previously because of improved methods of examination. The ability to intervene early, before enucleation must be considered, to preserve both life and vision is most promising in this group of patients.

Publications

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.
Melia BM, Diener-West M, Folk JC, Bennett SR, Montague PR, Weingeist TA for the COMS Group: Mortality and tumor growth in patients with small choroidal melanoma: A report from the COMS Group. Invest Ophthalmol Vis Sci 36(4, suppl):1036, 1995.

PARALLEL STUDY OF QUALITY OF LIFE IN MEDIUM-TUMOR PATIENTS
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In the COMS medium-tumor trial, the two treatments being compared - enucleation and plaque - are likely to have different psychological and physiological effects on the patients receiving them. Regardless of the presence or magnitude of survival differences between treatment groups, quality of life after treatment will become an important consideration in determining the best form of therapy. The primary goals of the COMS Quality of Life Study (QOLS) are 1) to estimate the quality of life and how it changes in choroidal melanoma patients from the time of diagnosis and enrollment into the COMS and through a 5-year follow-up period, and 2) to compare quality of life and how it changes in patients treated with plaque versus enucleation. The study incorporates multiple, prospective quality of life assessments, with a baseline evaluation made before randomization and follow-up assessments made six months after enrollment and at yearly intervals thereafter. Interviews are conducted on the telephone by interviewers located at the COMS Coordinating Center.

Publications

COMS Quality of Life Study Group: Incorporating a quality of life assessment into an ongoing multi-center clinical trial: The COMS experience. COMS-QOLS Report No. 2. (Submitted)
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 6:5-18, 1999.
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 Manual of Procedures
Manos KS, Moy CS for the COMS-QOLS Group: Incorporating a quality of life assessment into an ongoing multi-center clinical trial: problems and recommendations. Controlled Clin Trials 18:104, 1997.

PHYSICIAN FACTORS INFLUENCING PATIENT RECRUITMENT
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A survey of COMS ophthalmologists, radiation oncologists, and clinic coordinators was conducted regarding their attitudes towards clinical trials and the impact of participating in clinical research on physicians' perspectives. The goal was to correlate physician attitudes with rate of patient accrual in COMS clinical trials.

Publications

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.

ANALYSIS OF THE PATTERN OF ONCOGENE ACTIVATION IN THE DNA OF PATIENTS WITH UVEAL MELANOMA
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Dr. Daniel Albert, Director of the COMS Pathology Center in Boston, analyzed the pattern of oncogene activation in the DNA of tumor samples of eyes of COMS patients received at the Pathology Center. The purpose of the Study is to identify mutations which predispose to formation of choroidal melanoma by investigating the correlations between oncogene activation and histological data and between oncogene activation and tumor prognosis.

Publication

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.

NUCLEOLAR ORGANIZATION REGIONS IN CHOROIDAL MELANOMA
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Drs. Dennis Marcus and Daniel Albert conducted an ancillary study at the COMS Pathology Center to identify the malignant potential of uveal melanocytic lesions and elucidate the effect of radiation on the malignant potential of melanoma cells.

Publication

Marcus DM, Minkovitz JB, Wardwell SC, 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.

NATURAL HISTORY OF UNTREATED CHOROIDAL MELANOMA
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Dr. Bradley Straatsma, of COMS Clinical Center 16 at Jules Stein Eye Institute in Los Angeles, proposed to assess the natural history of patients evaluated for the COMS who were eligible for either the medium tumor trial or the large tumor trial but who elected to remain untreated. Patients continue to be followed in this ongoing project.

INTRAOPERATIVE ULTRASOUND
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Sandra Frazier Byrne, the Director of the COMS Echography Center, lead an informal study to investigate ultrasound plaque localization techniques. Fifteen COMS clinical centers participated in this ancillary study. Of 133 reported plaque localizations from these centers, 81 echogram sets taken at the time of plaque surgery had been received by the Echography Center. Correct plaque position was confirmed in about 85% of cases; the majority of the remaining echography studies were ungradable due to technical deviations. Publication of results from this study is contingent upon the availability of local control rates and at least 2 years of follow-up.

DETECTION OF MELANOCYTE STIMULATING HORMONES (MSH) RECEPTORS IN OCULAR MELANOMA TISSUE
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Receptors for melanocyte stimulating hormones (MSH) have been found to be expressed in most cutaneous melanoma metastases, but it is not known whether MSH receptors are expressed in ocular or cutaneous melanoma cells, or in normal or neoplastic ocular melanocytes. Expression of MSH receptors in normal or diseased ocular melanocytes would have implications for the basic biology of the target cells as well as for the development of antineoplastic chemotherapeutic agents for treatment of melanoma. The study was modified to incorporate evaluation of estrogen receptors in uveal melanoma. A publication is in preparation.

A COMPARISON OF TUMOR MEASUREMENTS DETERMINED BY TRANSILLUMINATION AND DIRECT MEASUREMENT IN FRESH, FIXED AND PROCESSED GLOBES
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Dr. Daniel Albert of the COMS Pathology Center conducted this study comparing tumor size as determined by transillumination and direct observation at various stages of processing of enucleated globes containing melanomas. A grading of subretinal fluid and shape of tumor based upon histopathology was also undertaken to investigate differences in tumor dimension measurements based on these characteristics.

Publications

Umlas J, Albert D, Diener-West M for the Collaborative Ocular Melanoma Study Group: Correlation of transillumination size and microscopic measurement of choroidal melanoma. Invest Ophthalmol Vis Sci 35(4):1925, 1994.
Umlas J, Diener-West M, Robinson NL, Green WR, Grossniklaus HE, Albert DM: Comparison of transillumination and histologic slide measurements of choroidal melanoma. Arch Ophthalmol 115(4):474-477, 1997.

DNA FLOW CYTOMETRY IN UVEAL MALIGNANT MELANOMAS
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Dr. Christine Corriveau and Dr. Jean Deschenes of the University of Montreal investigated the DNA content and mitotic activity of uveal melanoma using flow cytometry. In preliminary research utilizing tissue from 45 uveal melanoma, they found that the percentage of cells in the S phase of the cell cycle was strongly associated with more aggressive histopathologic cell types; in addition, a quantification of aneuploidy was a very strong predictor of mortality. The ancillary study was designed to replicate the earlier work in COMS enucleated patients.

Publications

Tabesh T, Duclos AJ, Corriveau C, et al.: Cell-cycle analysis of uveal melanoma. Inv Ophthalmol Vis Sci 37(3):S208, 1996.

HISTOLOGIC ASSESSMENT OF THE MICROCIRCULATION OF UVEAL MELANOMA
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Dr. Robert Folberg and Dr. Thomas Weingeist of the University of Iowa proposed to assess vascular microcirculatory patterns from histologic sections of eyes removed for choroidal melanoma in the COMS. In previous research by Dr. Folberg and his colleagues, certain tumor vascular patterns were found to be associated with death from metastatic disease. Ultimately, the development of noninvasive techniques to identify these prognostic vascular patterns would enhance the management of choroidal melanoma. This study is ongoing.

HOW CLINIC COORDINATORS SPEND THEIR TIME
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A survey of COMS clinic coordinators was conducted to assess the types of activities performed and the relative amount of time spent on each. This study yielded a profile of clinic responsibilities across the COMS group. Comparisons among subgroups of coordinators (e.g., nurses, ophthalmic technicians, other) may be of interest. Evaluation of the proportion of time spent on each activity and whether time spent on COMS activities is correlated with the number of patients reported and/or enrolled was also planned.

Publication

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.

APOPTOSIS IN UVEAL MELANOMA
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Using previously cut sections from 100 randomly selected COMS melanomas and from 20 randomly selected metastases, Dr. Daniel Albert evaluated whether there is a correlation between cell type and degree of apoptosis, whether protection of intraocular melanomas from the immune system results in relative resistance to apoptosis, and whether bc1-2 or FasL expression is involved in regulation of apoptosis in uveal melanoma.

Publication

Imesch PD, Lovitt BT, Albert DM for the COMS Group: Apoptosis in intraocular and metastatic melanomas. Inv Ophthalmol Vis Sci 39(4):S414, 1998.

MELANOMA INHIBITORY ACTIVITY (MIA) AS AN INDICATOR OF EARLY METASTATIC DISEASE
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Dr. Frederick Davidorf, principal investigator of the COMS clinical center in Columbus, Ohio, and Dr. Greg LaValle, surgical oncologist, initiated an investigation of the relationship between melanoma inhibitory activity and early metastatic disease. It was hypothesized that this method might be useful at the time of melanoma diagnosis for identifying patients at greatest risk of metastatic disease. This study is ongoing.

MORTALITY FOLLOW-UP OF ELIGIBLE PATIENTS NOT ENROLLING IN THE COMS LARGE TUMOR TRIAL
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Ms. Marta Marsh of the COMS Coordinating Center proposed to determine whether overall and cause-specific mortality differ among patients who agreed to random treatment assignment and those who elected to choose their own treatment. The availability of data for this group of eligible patients who did not enroll in the large tumor trial provides a rare opportunity to assess the external validity of the large tumor trial mortality results. This study is ongoing.

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