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| Name | Class |
|---|---|
| Instituto Mexicano del Seguro Social | OTHER_GOV |
| University of Guadalajara | OTHER |
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The purpose of this study is to evaluate the therapeutic efficacy of interferon alfa 2b and topical mitomycin C in patients with diagnosis of conjunctival-corneal intraepithelial neoplasia.
The corneal and conjunctival intraepithelial neoplasia is the most common malignant tumor of the ocular surface. Classic treatment is complete excision with safety margins, however, usually the edges are not sharp and difficult clinical differentiation between healthy areas that are not; to this treatment has joined him carrying out cryotherapy bedding and borders . Despite this treatment the recurrence rate ranges from 9-52 %. Antineoplastic drugs have been used either as adjuvant or primary treatment . Among the drugs used the investigators have mitomycin C (MMC) and interferon alpha 2b (INFα 2b).
Controlled clinical trial , single-blind , randomized . Non-probability sampling of consecutive cases. Patients will be assigned to treatment with MMC or INFα2b Periodic clinical evaluations and photos will be made. Time of resolution, resistance and adverse effects will be determined.
Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months).
Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitomycin C | Active Comparator | Mitomycin C 0.04% 4 times daily for 7 days and 7 days off until resolution of neoplasia (3-6 cycles). |
|
| Interferon alfa 2b | Active Comparator | Interferon alfa-2b 1 million IU/ml 4 times daily until complete resolution of the tumor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitomycin C | Drug | Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic effect - 100% resolution- with interferon alfa-2b and mitomycin C in patients diagnosed with primary conjunctival-corneal intraepithelial neoplasia | Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months). Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences. | One month to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects with topic therapy | Watch as topical treatment is maintained and at least one years after the resolution of the lesion. | One to two years |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of conjunctival-corneal intraepithelial neoplasia | Watch at least one year after the resolution of the lesion to detect recurrence. | One year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alvarado Beatriz, M.D. | Instituto Mexicano del Seguro Social | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMSS Centro Médico de Occidente | Guadalajara | Jalisco | Mexico |
we intend to publish the results as a scientific article with all results of participants
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| ID | Term |
|---|---|
| D016685 | Mitomycin |
| D000077190 | Interferon alpha-2 |
| D007438 | Introns |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
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|
| Interferon Alfa-2b | Drug | Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences |
|
|
| D001389 |
| Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |