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| Name | Class |
|---|---|
| Aleppo University Hospital | UNKNOWN |
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The investigators want to assess the safety and efficacy of using intralesional 5-FU for the management of different types of BCC (including all the types EXCEPT the infiltrative one), by estimating different outcomes after the intralesional administration of 5-FU to BCC patient. Patients are randomly selected from the outpatient dermatologic clinic in the Aleppo University Hospital (AUH) over a period of 12 months and then these patients are followed up over another 12 months.
Brief Description: The investigatorswant to assess the safety and efficacy of using intralesional 5-FU for the management of different types of BCC (including all the types EXCEPT the infiltrative one), by estimating different outcomes after the intralesional administration of 5-FU to BCC patient. Patients are randomly selected from the outpatient dermatologic clinic in the Aleppo University Hospital (AUH) over a period of 12 months and then these patients are followed up over another 12 months.
Detailed Description: Clinicians routinely consider surgical removal as the best and sometimes the only cost-effective treatment of Basal cell carcinoma, but several studies have discussed other promising treatment approaches for BCC including 5% 5-FU cream which is indicated for the treatment of superficial BCC, in addition many studies have investigated the efficacy of the combination of 5-FU with Imiquimode or cryoablation presenting promising results, however when searching the medical literature there was only few studies dealing with types other than superficial BCC, in addition intralesional administration of 5-FU alone was not thoroughly assessed so far even though there are some studies showing positive results suggesting 5-FU to be a cost-effective alternative to surgical excision, but as these papers are asking for further studies and stronger evidence the invistigators decided to conduct this study in accordance with the best recommendations reached by latest medical literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with intralesional 5-fluorouracil. | Experimental |
| |
| Patients with Surgery | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Fluorouracil | Drug | The invistigators want to assess the safety and efficacy of using intralesional 5-FU for the management of different types of BCC (including all the types EXCEPT the infiltrative one), by estimating different outcomes after the intralesional administration of 5-FU to BCC patient. Patients are randomly selected from the outpatient dermatologic clinic in the Aleppo University Hospital (AUH) over a period of 12 months and then these patients are followed up over another 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Histologic complete response rate | defined by absence of any tumor on the basis of histologic analysis of the excised specimen. | 1 - 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sides effect | The patient will be monitored and followed up for 365 days after the injection. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ibrahim Arnaout, M.D. Candidate | Contact | +963993279977 | ibrahim.arnaout25@gmail.com | |
| George Zakhour, M.D. Candidate | Contact | +963 959 115 307 | geo.zakhour@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Noura Abdulrahman, M.D. | Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, Syria | Principal Investigator |
| Rama Haj mharram, M.D. | Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, Syria |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ibrahim Arnaout | Recruiting | Aleppo | Syria |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| SURGERY | Other | Total excision of the lesion |
|
| Study Director |
| Ahmad Yamen Arnaout, M.D. | Faculty of Medicine, University of Aleppo, Aleppo, Syria. | Study Director |
| Silva Ishkhanian, PhD | Department of Dermatology and Venereology, Faculty of Medicine, University of Aleppo, Aleppo, Syria | Study Director |
| D018295 |
| Neoplasms, Basal Cell |
| D006571 |
| Heterocyclic Compounds |