Plain English Summary
Background and study aims
Harmonic analysis has been proven to be used to assess circulation status. In this study, we will observe the correlation between various common gynecological diseases and harmonic indicators through harmonic analysis. It is expected that harmonic indicators may become risk indicators for common gynecological diseases.
Who can participate?
Adults aged 20 and older with gynecological diseases.
What does the study involve?
Participants are provided with information sheets and obtain written informed consent. Information on lifestyle questionnaires and medical history are updated in each follow-up visit. Participants are then invited to a clinic room for radial pressure wave measurement.
What are the possible benefits and risks of participating?
Doctors take the radial pulse spectrum as risk variables based on the study and previous research. The patients may benefit from early detection of gynecological diseases in the future. The radial pulse measuring device is non-invasive.
Where is the study run from?
Taipei City Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
April 2018 to March 2022
Who is funding the study?
Taipei City Hospital (Taiwan)
Who is the main contact?
1. Dr Chih-Yu Chen (Public), tpech.anthony@m2k.com.tw
2. Dr Sheng-Hung Wang (Scientific), rax.wang@miiann.com
Trial website
Contact information
Type
Public
Primary contact
Dr Chih-Yu Chen
ORCID ID
Contact details
No.10
Sec. 4
Ren’ai Rd.
Da’an Dist
Taipei City
106
Taiwan
+886 227093600
tpech.anthony@m2k.com.tw
Type
Scientific
Additional contact
Dr Sheng-Hung Wang
ORCID ID
Contact details
26F-1
No. 161
Songde Rd.
Taipei
11085
Taiwan
+886 223463003
rax.wang@miiann.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
TCHIRB-10703121-E
Study information
Scientific title
A study on gynecological disease classification by harmonic analysis of pressure pulse waveform
Acronym
Study hypothesis
Harmonic analysis has been proven to be used to assess circulation status. In this study, we will observe the correlation between various common gynecological diseases and harmonic indicators through harmonic analysis. It is expected that harmonic indicators may become risk indicators for common gynecological diseases.
Ethics approval
Approved 20/04/2018, Institutional Review Board of Taipei City Hospital (8F., No. 10, Sec. 4, Ren’ai Rd., Da’an Dist., Taipei City 106, Taiwan (R.O.C.); +886 227093600; no email provided), ref: TCHIRB-10703121-E. Extension granted 08/04/2019.
Study design
Non-invasive observational study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
No participant information sheet available
Condition
Risk factors in gynecological diseases
Intervention
All subjects underwent radial pressure wave measurement. Spectrum analysis of radial pressure wave was calculated and transformed into Fourier series coefficients Cn and Pn.
The enrolled group is investigated from April 2018. Both oral and written information about the study is given to the subjects. Informed consent is obtained from subjects after receiving approval from the institutional review board of Taipei City Hospital. The enrolled patients receive radial pulse wave measurement while referral until the end of the study or quit the project.
The study consists of two clinical tests:
1. The cross-sectional part measures the radial blood pressure wave when a person first joined this study. The radial pulse spectrum index is derived from the measurement. The measurement is noninvasive. The interactions among the various common gynecological diseases and the risk factors (including the radial pulse spectrum index) are evaluated. The medical records of subjects including the blood test, urine examination, medication history, and lifestyle questionnaires to investigate the risk confounded such as age, gender, body mass index, blood pressure, low-density cholesterol, high-density cholesterol, and smoke history are analysed.
2. The longitudinal part: This part takes the risk evaluation of cross-sectional cohort study as the baseline. We continue to measure the radial pulse spectrum and record the new-onset gynecological diseases at 4-year intervals.
In both parts of the cross-sectional and longitudinal part, it builds up the clinical risk variables for patients with gynecological diseases. Those clinical variables are safe enough to facilitate in routine clinical practice and also are cost-effective to repeat within months. Thus, periodic screening for those risk factors may help the doctors to evaluate the conditions of patients with gynecological diseases.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Radial blood pressure wave is assessed using a miniature pressure transducer (TD01C, Taiwan) at time of enrollment
2. Hormones (such as E2, LH, FSH and Prolactin) are assessed using blood test at time of enrollment
3. CA-125 and AFP are assessed using blood test at time of enrollment
Secondary outcome measures
Physician diagnosis from the medical record at time of enrollment.
Overall trial start date
01/04/2018
Overall trial end date
31/03/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with gynecological diseases
2. Over 20 years old
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1,500
Participant exclusion criteria
Severe diseases or acute symptoms are excluded if the pressure wave measurement could not be performed
Recruitment start date
08/05/2018
Recruitment end date
31/03/2022
Locations
Countries of recruitment
Taiwan
Trial participating centre
Taipei City Hospital
Department of Obstetrics and Gynecology
Renai Branch
Taipei
106
Taiwan
Sponsor information
Organisation
Taipei City Hospital
Sponsor details
No.10
Sec. 4
Ren’ai Rd.
Da’an Dist.
Taipei City
106
Taiwan
+886 227093600
tpech.anthony@m2k.com.tw
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Taipei City Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
31/03/2023
Participant level data
Other
Basic results (scientific)
Publication list