Condition category
Urological and Genital Diseases
Date applied
19/05/2020
Date assigned
25/05/2020
Last edited
22/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://english.tch.gov.taipei/

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

Publication citations

Additional files

Editorial Notes

22/05/2020: Trial’s existence confirmed by Institutional Review Board of Taipei City Hospital.