Evaluation of the therapeutic efficacy of injectable 5FU solution for basal cell carcinoma in patients referred to Loghman Hakim and Shohada-e Tajrish hospitals between 2020 and 2021
Determining the percentage of people who are completely good or smaller by injecting 5FU lesions into the lesion,Determining the relationship between response rate and initial size, anatomical location, pathology type, and duration of lesion formation,Determining the relationship between response rate with age and gender
Design
Non-random sampling is a method for sampling. This means that all clients with BCC will be eligible to study.The size of the sample is determined by 50 people according to previous articles.The diagnosis of BCC will be based on histologically.
Settings and conduct
Demographic information is recorded through a questionnaire.Then,1 to 2 cc of 50mg / 5c 5FU solution will be injected in BCC lesion weekly.The injection is weekly and lasts until the lesion heals or lasts a maximum of 6 weeks.Then,the following criteria will be reviewed and graded at each session.The extent of the lesion reduction, the incidence of side effects, and the patient's pain and discomfort from the injection.At the end of the study, patients'lesions were removed by injection, a biopsy was performed and the pathology of the lesion was examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: people with BCC who are willing to participate in the study; people with BCC who can go for visiting weekly.
Exclusion criteria: recurrent BCC; very large BCC (larger than 2 cm); BCC around the eyes; patients with lymphoma or leukemia or immunodeficient; pregnant or lactating patients.
Intervention groups
Non-random sampling is a method for sampling. This means that all clients with BCC will be eligible to study.
Main outcome variables
Size of the lesion; pathology of the lesion; duration of treatment; dose of the drug; the effectiveness of the drug; the side effects of the drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200205046380N2
Registration date:2020-09-20, 1399/06/30
Registration timing:registered_while_recruiting
Last update:2020-09-20, 1399/06/30
Update count:0
Registration date
2020-09-20, 1399/06/30
Registrant information
Name
khatere zahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 5103
Email address
khaterezahedi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-04, 1399/01/16
Expected recruitment end date
2021-04-05, 1400/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic efficacy of injectable 5FU solution for basal cell carcinoma in patients referred to Loghman Hakim and Shohada-e Tajrish hospitals between 2020 and 2021
Public title
Evaluation of the therapeutic efficacy of injectable 5FU solution for basal cell carcinoma in patients referred to Loghman Hakim and Shohada-e Tajrish hospitals between 2020 and 2021
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with BCC who are willing to participate in the study
People with BCC who can go to the clinic for visiting
Exclusion criteria:
Recurrent BCC
Very large BCC (larger than 2 cm)
BCC around the eyes
Patients with lymphoma or leukemia or immunodeficiency or in pregnant or lactating patients
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The non-random sampling is a method for sampling.This means that all patients with BCC will be eligible to study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Skin Research Center - Shahid Beheshti University of Medical Sciences
Assessment the complete improvement or shrinkage of the lesion
Timepoint
Weekly until the healing of lesion or up to 6 weeks
Method of measurement
Observation and questionnaire
Secondary outcomes
1
Description
Evaluation of response to treatment based on initial size, anatomical location, pathology type, and duration of lesion formation and investigation the response to treatment based on age and gender
Timepoint
Weekly until the healing of lesion or up to 6 weeks
Method of measurement
Observation and questionnaire
Intervention groups
1
Description
Intervention group: 1-2 ml of the 50mg/ml 5FU solution (Kavosh Gostar Darou, Iran) will be injected in to the BCC lesion once a week until the resolution of the lesion or for a maximum duration of 6 weeks.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
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 the lesion, and the anatomical location of the lesion,Patient's gender and age, response rate based on observation of complete improvement or reduction of lesion size,Information about side effects of drug
When the data will become available and for how long
The data can be accessed after the publication of the results
To whom data/document is available
People working in academic and scientific institutions
Under which criteria data/document could be used
Data can only be used to improve individuals' disease condition.
From where data/document is obtainable
Dr. Khatere Zahedi 00989132154819 khaterezahedi4819@gmail.com
What processes are involved for a request to access data/document
Request via email with complete identification data of the individual, the institution he/she works in, thorough explanation of the reason of the request. Data can be accessed after investigation of the responsible agent.