Clinical Trial Protocol Iranian Registry of Clinical Trials

26 Sep 2021

Evaluation of the therapeutic efficacy of injectable 5FU solution for basal cell carcinoma in patients referred to Loghman Hakim and Shohada-e hospitals between 2020 and 2021

Protocol summary Size of the lesion; pathology of the lesion; duration of treatment; dose of the drug; the effectiveness of the Study aim drug; the side effects of the drug Determining the percentage of people who are completely good or smaller by injecting 5FU lesions into General information the lesion,Determining the relationship between response rate and initial size, anatomical location, Reason for update pathology type, and duration of lesion Acronym formation,Determining the relationship between IRCT registration information response rate with age and gender IRCT registration number: IRCT20200205046380N2 Design Registration date: 2020-09-20, 1399/06/30 Non-random sampling is a method for sampling. This Registration timing: registered_while_recruiting means that all clients with BCC will be eligible to study.The size of the sample is determined by 50 people Last update: 2020-09-20, 1399/06/30 according to previous articles.The diagnosis of BCC will Update count: 0 be based on histologically. Registration date Settings and conduct 2020-09-20, 1399/06/30 Demographic information is recorded through a questionnaire.Then,1 to 2 cc of 50mg / 5c 5FU solution Registrant information will be injected in BCC lesion weekly.The injection is Name weekly and lasts until the lesion heals or lasts a khatere zahedi maximum of 6 weeks.Then,the following criteria will be Name of organization / entity reviewed and graded at each session.The extent of the Country lesion reduction, the incidence of side effects, and the (Islamic Republic of) patient's pain and discomfort from the injection.At the Phone end of the study, patients'lesions were removed by +98 21 8804 5103 injection, a biopsy was performed and the pathology of Email address the lesion was examined. [email protected] Participants/Inclusion and exclusion criteria Inclusion criteria: people with BCC who are willing to Recruitment status participate in the study; people with BCC who can go for Recruitment complete visiting weekly. Exclusion criteria: recurrent BCC; very Funding source large BCC (larger than 2 cm); BCC around the eyes; patients with lymphoma or leukemia or immunodeficient; Expected recruitment start date pregnant or lactating patients. 2020-04-04, 1399/01/16 Intervention groups Expected recruitment end date Non-random sampling is a method for sampling. This 2021-04-05, 1400/01/16 means that all clients with BCC will be eligible to study. Actual recruitment start date Main outcome variables empty

1 Actual recruitment end date Shahid Beheshti University of Medical Sciences empty Street address Trial completion date Shohada-E-Tajrish hospital, Qods Sq., , Iran empty City Tehran Scientific title Province Evaluation of the therapeutic efficacy of injectable 5FU Tehran solution for basal cell carcinoma in patients referred to Postal code Loghman Hakim and Shohada-e Tajrish hospitals 1989934148 between 2020 and 2021 Approval date 2019-12-17, 1398/09/26 Public title Ethics committee reference number Evaluation of the therapeutic efficacy of injectable 5FU IR.SBMU.SRC.REC.1398.014 solution for basal cell carcinoma in patients referred to Loghman Hakim and Shohada-e Tajrish hospitals between 2020 and 2021 Health conditions studied Purpose Treatment 1 Inclusion/Exclusion criteria Inclusion criteria: Description of health condition studied People with BCC who are willing to participate in the Basal cell carcinoma study People with BCC who can go to the clinic for ICD-10 code visiting C44.01 Exclusion criteria: ICD-10 code description Recurrent BCC Very large BCC (larger than 2 cm) BCC Basal cell carcinoma of skin of lip around the eyes Patients with lymphoma or leukemia or immunodeficiency or in pregnant or lactating patients Primary outcomes Age No age limit Gender 1 Both Description Assessment the complete improvement or shrinkage of Phase the lesion 2 Timepoint Groups that have been masked Weekly until the healing of lesion or up to 6 weeks No information Method of measurement Sample size Observation and questionnaire Target sample size: 50 Randomization (investigator's opinion) Randomized Secondary outcomes Randomization description The non-random sampling is a method for sampling.This 1 means that all patients with BCC will be eligible to study. Blinding (investigator's opinion) Description Not blinded Evaluation of response to treatment based on initial size, Blinding description anatomical location, pathology type, and duration of Placebo lesion formation and investigation the response to Not used treatment based on age and gender Assignment Timepoint Single Weekly until the healing of lesion or up to 6 weeks Other design features Method of measurement Observation and questionnaire Secondary Ids Intervention groups empty

Ethics committees 1 Description Intervention group: 1-2 ml of the 50mg/ml 5FU solution 1 (Kavosh Gostar Darou, Iran) will be injected in to the BCC Ethics committee lesion once a week until the resolution of the lesion or for Name of ethics committee a maximum duration of 6 weeks. Research Ethics Committee of Skin Research Center - Category

2 Treatment - Drugs Province Tehran Recruitment centers Postal code 1983969411 Phone 1 +98 21 29901 Recruitment center Fax Name of recruitment center +98 21 2243 1919 Shohadaye Tajrish Hospital Email Full name of responsible person pr.offi[email protected] Dr. Mohammad Mehdi Forouzanfar Grant name Street address Grant code / Reference number Shohadaye Tajrish Hospital, Tajrish Square, Tehran, Is the source of funding the same sponsor Iran organization/entity? City Yes Tehran Title of funding source Province Shahid Beheshti University of Medical Sciences Proportion provided by this source Tehran 100 Postal code Public or private sector 1989934148 Public Phone Domestic or foreign origin +98 21 25719 Domestic Fax Category of foreign source of funding +98 21 2271 9014 empty Email Country of origin [email protected] Type of organization providing the funding Academic 2 Recruitment center Person responsible for general inquiries Name of recruitment center Loghman Hakim Hospital Contact Full name of responsible person Name of organization / entity Dr Omidvar Rezayi Shahid Beheshti University of Medical Sciences Street address Full name of responsible person Loghman Hakim Hospital, Makhsus Ave., Lashkar Khetere Zahedi Crossroad,Tehran, Iran crossroad, Tehran, Iran Position City Resident Tehran Latest degree Province Medical doctor Tehran Other areas of specialty/work Postal code Dermatology 1333635445 Street address Phone SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, +98 21 5541 9005 Iran Email City [email protected] Tehran Province Sponsors / Funding sources Tehran Postal code 1436943415 1 Phone 002188045103 Sponsor Email Name of organization / entity [email protected] Shahid Beheshti University of Medical Sciences Full name of responsible person Dr. Gholmali Tabarsat Person responsible for scientific Street address inquiries SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran Contact City Name of organization / entity Tehran Shahid Beheshti University of Medical Sciences

3 Full name of responsible person +98 21 8804 5103 Khatere Zahedi Email Position [email protected] Resident Latest degree Sharing plan Medical doctor Other areas of specialty/work Deidentified Individual Participant Data Set (IPD) Dermatology Yes - There is a plan to make this available Street address Study Protocol SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Yes - There is a plan to make this available Iran Statistical Analysis Plan City Yes - There is a plan to make this available Tehran Informed Consent Form Province Yes - There is a plan to make this available Tehran Clinical Study Report Postal code Yes - There is a plan to make this available 14369-43415 Analytic Code Phone Yes - There is a plan to make this available +98 21 8804 5103 Data Dictionary Email Yes - There is a plan to make this available [email protected] Title and more details about the data/document Information about the timing of diagnosis of disease,The type of lesion is based on the histology, the duration of Person responsible for updating data the lesion, and the anatomical location of the lesion,Patient's gender and age, response rate based on Contact observation of complete improvement or reduction of Name of organization / entity lesion size,Information about side effects of drug Shahid Beheshti University of Medical Sciences When the data will become available and for how Full name of responsible person long Khatere zahedi The data can be accessed after the publication of the Position results Resident To whom data/document is available Latest degree People working in academic and scientific institutions Medical doctor Under which criteria data/document could be used Other areas of specialty/work Data can only be used to improve individuals' disease Dermatology condition. Street address From where data/document is obtainable SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Dr. Khatere Zahedi 00989132154819 Iran [email protected] City What processes are involved for a request to access Tehran data/document Province Request via email with complete identification data of Tehran the individual, the institution he/she works in, thorough Postal code explanation of the reason of the request. Data can be 14369-43415 accessed after investigation of the responsible agent. Phone Comments

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