Comparison of survival among eligible patients not enrolled versus enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma.

Comparison of survival among eligible patients not enrolled versus enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma. Research Abstract Details 

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Comparison of survival among eligible patients not enrolled versus enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma. Abstract Text:

Marta M Gilson,Marie Diener-West,Barbara S Hawkins,

PURPOSE: To compare survival between patients enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation therapy (PERT) for large choroidal melanoma and eligible patients who did not enroll. METHODS: COMS clinical center personnel prospectively reported to the COMS Coordinating Center all patients with choroidal melanoma examined between November 1986 and December 1994. Deaths of enrolled patients were reported prospectively by clinical center personnel. In a COMS ancillary study, we retrospectively searched medical records of participating clinical centers, the Social Security Death Index, and the National Death Index to determine vital status of eligible patients not enrolled. Cox proportional hazards analysis was used to compare survival within 10 years of baseline reporting and before July 31, 2000, of enrolled patients versus eligible patients not enrolled. RESULTS: Clinical centers that received local institutional review board approval to participate in this ancillary study prospectively reported on 129 of 299 eligible patients not enrolled in the COMS PERT trial. The baseline characteristics of the 129 patients included in this ancillary study were similar to those of the 170 patients not included; 73 patients were reported as deceased. Previously identified prognostic covariates, i.e., age and longest tumor diameter, were confirmed to predict survival in both enrolled patients and eligible patients not enrolled; trial enrollment was not predictive. After adjusting for prognostic covariates and stratifying by clinical center, the estimated hazard ratio (enrolled vs. not-enrolled) was 1.12 (95% confidence interval: 0.83 to 1.51). CONCLUSIONS: The results of the COMS PERT trial should be generalizable to all patients with choroidal melanoma meeting the eligibility criteria for that trial. While the methods we used may not be generalizable to all clinical trials because of unique features of the COMS, other researchers may be able to use similar methods to determine the generalizability of their trial results.

Comparison of survival among eligible patients not enrolled versus enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma. Publishing Authors By Initials

MM Gilson,M Diener-West,BS Hawkins,

For similar geographic locations: americas: north america: united states research abstracts see: geographic locations: americas: north america: united states research

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Comparison of survival among eligible patients not enrolled versus enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma. Journal Published:

PUBLICATION TYPE: Research Support, N.I.H., Extr

Journal: Ophthalmic epidemiology

VOLUME: 14

Page Numbers: 251-7

Journal Abbreviation:

ISSN: 0928-6586

DAY: 3

MONTH: 12

YEAR: 2007

Comparison of survival among eligible patients not enrolled versus enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma. Information

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LANGUAGE: eng

NlmUniqueID: 9435674

Comparison of survival among eligible patients not enrolled versus enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma. Keywords Mesh Terms:

KEYWORDS: United States

MESH TERMS: epidemiology

Chemical & Substance for Abstract: Comparison of survival among eligible patients not enrolled versus enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma. Information

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Grant and Affiliation Information for Comparison of survival among eligible patients not enrolled versus enrolled in the Collaborative Ocular Melanoma Study (COMS) randomized trial of pre-enucleation radiation of large choroidal melanoma.

AFFILIATION: Department of Surgery, School of Medicine, Johns Hopkins University, USA. mmgilson@jhmi.edu

Country: England

AGENCY: United States NEI

GRANT: U10EY06287

ACRONYM: EY

MEDLINETA: Ophthalmic Epidemiol

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