About The COMS
Clinical Trials for Choroidal Melanoma
The quality of life of patients with medium choroidal melanoma is also being assessed. Patients are interviewed by telephone before enrolling in the COMS and several times after treatment.
COMS clinical trials are funded by the National Eye Institute and the National Cancer Institute of the National Institutes of Health of the United States, and are being conducted at more than 40 medical centers in the United States and Canada. Important information collected about the patients who take part in each COMS clinical trial is forwarded to a central data center called a Coordinating Center. The quality of life interviewer, who conducts telephone interviews with medium tumor patients, is also located at the COMS Coordinating Center. The COMS Coordinating Center is located at the Johns Hopkins Medical Institutions in Baltimore, Maryland.
When two forms of therapy are being compared in a clinical trial, how will a patient be assigned to one type of treatment or the other?In a clinical trial, one group of patients receives the"standard" or more common treatment and another receives an alternative treatment which is compared to the standard. For example, as in the COMS clinical trial for medium tumors, one group may receive the usual surgical treatment of a certain cancer while another group with the same type of cancer may receive radiation therapy to see which one most often leads to longer life. The doctors do not know which treatment is better. Both treatments have been effective in ridding some patients of cancer. No one knows which treatment gives the patient a better chance of a normal life-span or whether they are equally good. Some patients may not be eligible for a clinical trial because they have other medical problems. In such cases, the doctor does not recommend that enrollment in a clinical trial be considered. To prevent any bias or prejudice of the patient or the doctor from influencing the results of the clinical trial, a patient is assigned to one treatment or another by randomization. When the patient and the doctor agree to randomization, the treatment received by the patient is selected by chance. The patient has an equal chance of receiving either treatment. The doctor has already judged that the patient is equally likely to benefit from either treatment based on current knowledge.
If your doctor asks you to consider a trial using randomization, he or she is uncertain which of two treatments will be better for you and is equally willing for you to have either one. If your doctor believes that you would benefit more from one particular treatment than from the other, he or she will recommend that treatment to you and will not ask you to take part in a clinical trial.
Although certain evaluations should be conducted by your COMS physicians, participation in the COMS does not mean that a patient should stop seeing personal physicians for medical care. Your COMS doctors will keep your personal doctor informed about COMS examinations and treatment and will cooperate fully in your total medical care.
What happens to information about patients who take part in the Collaborative Ocular Melanoma Study?Aside from discussions with each patient's personal doctors, no information that identifies the patient is given to anyone outside the COMS. A complete set of medical records is kept for each patient taking part in the COMS; access to those records is restricted to safeguard the patient's privacy. When information about a patient is sent to the COMS Coordinating Center, the information is coded so that only the patient's own COMS doctor and clinic coordinator can identify him or her. At the COMS Coordinating Center, the information from all patients is pooled and analyzed to see which treatment is better. When clinically important information becomes available, these findings will be reported to the patients and published in medical and scientific journals, so that all doctors as well as future patients with choroidal melanoma can benefit from new knowledge. In these reports, individual patients are not identified.
Copyright © 1997, 1999, The Collaborative Ocular Melanoma Study. All rights reserved.