UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pathological investigation of thromboembolism in the obstetrics and gynecology disorder
Title of the study (Brief title)	Pathological investigation of thromboembolism in the obstetrics and gynecology disorder (PAINT Study)
Region	Japan

Condition
Condition	Venous Thromboembolism
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	YES

Objectives
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

Assessment
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.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Kiyoko Kato
Organization	Kyushu University Hospital
Division name	Department of Obstetrics and Gynecology
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka 812-8582, Japan
TEL	092-642-5395
Email	kkato@med.kyushu-u.ac.jp

Public contact
Name of contact person	Natsuko Yokota and Katsuko Egashira
Organization	Kyushu University Hospital
Division name	Department of Obstetrics and Gynecology
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

Sponsor
Institute	Department of Obstetrics and Gynecology, Kyushu University Hospital
Institute
Department

Funding Source
Organization	Department of Obstetrics and Gynecology, Kyushu University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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

Management information
Registered date	2016 Year 01 Month 27 Day
Last modified on	2018 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023957