UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020759 |
|---|---|
| Receipt number | R000023957 |
| Scientific Title | Pathological investigation of thromboembolism in the obstetrics and gynecology disorder |
| Date of disclosure of the study information | 2016/01/27 |
| Last modified on | 2018/07/30 10:13:54 |
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Basic information
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
Condition
Venous Thromboembolism
Classification by specialty
| Obstetrics 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
| 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
kkato@med.kyushu-u.ac.jp
Public contact
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
natsuko.yokota.192@s.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Kyushu University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023957
