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Comparative study of breast mass evaluation by a new diagnostic method (Breast Light) and mammography in women over forty years

Protocol summary

Study aim
Determining the diagnostic value of the new device (Breast Light) in comparison with mammography for evaluating breast masses
Design
The present study is one of the studies evaluating diagnostic tests and screening. All eligible people (including 252 people) will be examined with both Brestlight and mammography diagnostics based on available sampling. Clearly, blinding and randomization do not apply in this study.
Settings and conduct
In this study, 252 women over the age of 40 who are candidates for breast cancer screening or who have symptoms such as mastalgia, nipple discharge, changes in the appearance of the breast, etc., according to the doctor, need to be screened for diagnostic methods. Initially, the specialist will evaluate the breast tissue using a burst light device in a dark room through direct contact of the probe with the skin of the person. Seeing the dark areas of the cluster indicates malignancy and the results will be recorded by the specialist. They should then be re-examined with a mammogram. It should be noted that in people who will be diagnosed with the disease will be directed to continue treatment and biopsy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women 40 years of age and older, women candidates for breast cancer screening Exclusion criteria: Reluctance to undergo screening with Brest Light, pregnancy
Intervention groups
In this study, two diagnostic interventions, Brest Light and mammography, will be used to evaluate breast masses. In this way, all the subjects will be examined first using the new Brest Light diagnostic method, and then mammography will be performed
Main outcome variables
Primary outcome variables include true positive, true negative, false positive, and false negative of the diagnostic test Brest Light

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090701002114N8
Registration date: 2021-01-13, 1399/10/24
Registration timing: prospective

Last update: 2021-01-13, 1399/10/24
Update count: 0
Registration date
2021-01-13, 1399/10/24
Registrant information
Name
Fatemeh Yari
Name of organization / entity
Lorestan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1222 6450
Email address
yari.f@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-19, 1399/10/30
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of breast mass evaluation by a new diagnostic method (Breast Light) and mammography in women over forty years
Public title
Evaluation of breast mass diagnosis with breast light and mammography
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 40 and over Women who are candidates for breast cancer screening
Exclusion criteria:
pregnancy Reluctance to perform the screening process by Brest Light
Age
From 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 252
More than 1 sample in each individual
Number of samples in each individual: 2
Each participant is first examined with a Brest Light device and then the same person is examined with a mammogram, so there will be two samples for each person to examine breast masses
Randomization (investigator's opinion)
N/A
Randomization description
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
Ethics committee of Lorestan University of Medical Sciences
Street address
Office of Research Ethics Committee, Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences, University Campus Complex, km 3 of Khorramabad Boroujerd Road, Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2021-01-03, 1399/10/14
Ethics committee reference number
IR.LUMS.REC.1399.258

Health conditions studied

1

Description of health condition studied
Diagnosis and screening of breast mass
ICD-10 code
ICD-10 code description
Breast screening

Primary outcomes

1

Description
The true positive detection rate of the Brest Light device
Timepoint
When using the Brest Light device, and then with a subsequent examination by mammography
Method of measurement
By examining the number of people who are positive for the Brest Light screening test, and these people are diagnosed as really ill with a subsequent examination through mammography and biopsy

2

Description
The true negative detection rate of the Brest Light device
Timepoint
When using the Brest Light device, and then with a subsequent examination by mammography
Method of measurement
By examining the number of people who are negative for the Brest Light screening test, and these people are diagnosed as really health with a subsequent examination through mammography

3

Description
The false positive detection rate of the Brest Light device
Timepoint
When using the Brest Light device, and then with a subsequent examination by mammography
Method of measurement
By examining the number of people who are positive for the Brest Light screening test, if by the next check by mammography these people are healthy

4

Description
The false negative detection rate of the Brest Light device
Timepoint
When using the Brest Light device, and then with a subsequent examination by mammography
Method of measurement
By examining the number of people who are negative for the Brest Light screening test, if by the next check by mammography these people are ill

Secondary outcomes

1

Description
Brest Light diagnostic sensitivity
Timepoint
When using the Brest Light device, and then with a subsequent examination by mammography
Method of measurement
Divide the number of people who have a positive diagnostic test and are really sick by the number of people who have a positive screening result

2

Description
Brest Light diagnostic specificity
Timepoint
When using the Brest Light device, and then with a subsequent examination by mammography
Method of measurement
Divide the number of people who have a negative diagnostic test and are really healthy by the number of people who have a negative screening result

Intervention groups

1

Description
Intervention group: The first intervention group includes all people for whom the Brest Light diagnostic method is used to examine breast masses.
Category
Diagnosis

2

Description
Intervention group: The second intervention group includes the same people under the first intervention. This time, mammographic diagnostic method will be used to examine breast masses
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Asali hospital
Full name of responsible person
Masoumeh Ghaffarzadeh
Street address
Asali Hospital, 14th Street, Palestine Alley
City
Khorramabad
Province
Lorestan
Postal code
6818795895
Phone
+98 66 3340 6099
Email
asali.hospital@lums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Ibrahim Fallahi
Street address
medical school., 4 km Khorramabad Boroujerd Road., Kamalvand
City
khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3312 0172
Email
falahi.e@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fatemeh Yari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Medical school., 4 km Khorramabad Boroujerd Road., Kamalvand
City
Khorramabad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3312 0133
Email
yari.f@lums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fatemeh Yari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Medical school., 4 km Khorramabad Boroujerd Road., Kamalvand
City
Khorramabad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3312 0133
Email
yari.f@lums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fatemeh Yari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
medical school., 4 km Khorramabad Boroujerd Road., Kamalvand
City
Khorramabad
Province
Lorestan
Postal code
381351698
Phone
+98 66 3312 0133
Email
yari.f@lums.ac.ir

Sharing plan

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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
It is possible to share all the data while maintaining the principle of not mentioning the names of individuals
When the data will become available and for how long
Six months after the publication of the related article
To whom data/document is available
University researchers, gynecologists and radiologists
Under which criteria data/document could be used
The data of the present study can be used for additional research, after obtaining permission and approval from the Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences.
From where data/document is obtainable
Refer to the project manager, Dr. Fatemeh Yari, with email address yari1672@yahoo.com, and contact number 09163613621
What processes are involved for a request to access data/document
After completing the research and publishing the relevant article, individuals can apply to the Vice Chancellor for Research and Technology of Lorestan University of Medical Sciences to receive documents and after obtaining permission from this department, send a confirmation from the Vice Chancellor for Research to the project manager. Can access documentation
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