UMIN-CTR Clinical Trial

Public title

Pathological investigation of thromboembolism in the obstetrics and gynecology disorder

Acronym

Pathological investigation of thromboembolism in the obstetrics and gynecology disorder (PAINT Study)

Scientific Title

Pathological investigation of thromboembolism in the obstetrics and gynecology disorder

Scientific Title:Acronym

Pathological investigation of thromboembolism in the obstetrics and gynecology disorder (PAINT Study)

Region

Japan

Condition

Venous Thromboembolism

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To clarify the correlation between thromboembolism and protein S gene mutation in the patients of obstetrics and gynecology. In addition, to investigate the availability of protein S-specific activity as the screening for congenital thrombotic factor in the patients of obstetrics and gynecology.

Basic objectives2

Others

Basic objectives -Others

Protein S gene mutation

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Frequency of protein S gene mutation

Key secondary outcomes

Correlation between protein S gene mutation and protein S specific- activity, correlation among other parameters of coagulation system, hormone level and protein S-specific activity.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

Group A:Patients with the history of thromboembolism
1.Patients of obstetrics and gynecology with the history of thromboembolism (deep vein thrombosis or pulmonary embolism).
2.Patients providing the written informed consent.
3.Patient with 20 years or older at the date of informed consent.
Group B:Patients without the history of thromboembolism
1.Patients without the history of thromboembolism in obstetrics and gynecology
2.Patients providing the written informed consent.
3.Patient with 20 years or older at the date of informed consent.
Group C:Normal female subjects
1.Normal female subjects in human genome/gene analysis research "Pathological Investigation of the factor of thromboembolism peculiar in Asian" conducted at Faculty of Nutritional Science, Nakamura Gakuen University.
2.Patient with 20 years or older at the date of informed consent.

Key exclusion criteria

Group A:Patients with the history of thromboembolism
1.Patients with pregnant.
2.Patients with post partum within 28 days.Patients within 28 days after surgery (exclude surgeries less than 30 minutes).
Group B:Patients without the history of thromboembolism
1.Patients with pregnant.
2.Patients with post partum within 28 days.Patients within 28 days after surgery (exclude surgeries less than 30 minutes).
4.Patients with anti coagulant therapy (eligible if low-molecular-weight heparin is available more than 2 weeks before collecting blood).
5.Patients who initiated the sex steroid hormone therapy within 3 months.
Group C:Normal female subjects
The information from human genome/gene analysis research"Pathological Investigation of the factor of thromboembolism peculiar in Asian" in Faculty of Nutritional Science,Nakamura Gakuen University is secondarily used.
1.Patients with hormonal therapy.
2.Patients with pregnant.
3.Patients with malignant disease.
4.Patients with anti coagulant therapy (eligible if low-molecular-weight heparin is available more than 2 weeks before collecting blood).

Target sample size

600

Name of lead principal investigator

1st name
Middle name
Last name	Kiyoko Kato

Organization

Kyushu University Hospital

Division name

Department of Obstetrics and Gynecology

Zip code

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka 812-8582, Japan

TEL

092-642-5395

Email

kkato@med.kyushu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Natsuko Yokota and Katsuko Egashira

Organization

Kyushu University Hospital

Division name

Department of Obstetrics and Gynecology

Zip code

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka 812-8582, Japan

TEL

092-642-5395

Homepage URL

Email

natsuko.yokota.192@s.kyushu-u.ac.jp

Institute

Department of Obstetrics and Gynecology, Kyushu University Hospital

Institute

Department

Personal name

Organization

Department of Obstetrics and Gynecology, Kyushu University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

九州大学病院（福岡県）
国家公務員共済組合浜の町病院（福岡県）
親愛ステーションクリニック（福岡県）
長崎国際大学（長崎県）
中村学園大学（福岡県）
北九州市立医療センター（産婦人科）

Date of disclosure of the study information

2016

Year

01

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

01

Month

19

Day

Date of IRB

Anticipated trial start date

2016

Year

01

Month

27

Day

Last follow-up date

2018

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

2018

Year

10

Month

31

Day

Date analysis concluded

Other related information

Multi-center retrospective observational study, human genome study
Subject group (Group A) and control group 1 (Group B) Patients who had a medical examination in the obstetrics and gynecology from January 28, 2016 to March 31, 2018 and meet inclusion criteria.
Control group 2 (Group C) contains female normal subjects.
The information of 300 third grade female students in Faculty of Nutritional Sciences, Nakamura Gakuen University participated in health check in 2013 and 2014 is secondarily used among the normal subjects of human genome/gene analysis study entitled "Pathological elucidation on critical factor of thrombosis peculiar to Asians" carried out in Faculty of Nutritional Sciences, Nakamura Gakuen University (Principal investigator, Prof. Hiroko Tsuda).

Clinical examination
Protein S gene analysis, Protein S-spesific activity, Protein S activity Protein C activity, antithrombin activity, PT, APTT, D-dimer, fibrinogen, Thrombin-antithrombin complex, estradiol, progesteron

Registered date

2016

Year

01

Month

27

Day

Last modified on

2018

Year

07

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023957