UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017697 |
|---|---|
| Receipt number | R000020458 |
| Scientific Title | Research of Pregnancy with Malignant Cancer in Japan |
| Date of disclosure of the study information | 2015/06/24 |
| Last modified on | 2018/01/18 12:06:12 |
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Basic information
Public title
Research of Pregnancy with Malignant Cancer in Japan
Acronym
Research of Pregnancy with Malignant Cancer in Japan
Scientific Title
Research of Pregnancy with Malignant Cancer in Japan
Scientific Title:Acronym
Research of Pregnancy with Malignant Cancer in Japan
Region
| Japan |
Condition
Condition
Cancer in pregnancy
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Pediatrics |
| Ophthalmology | Dermatology | Oto-rhino-laryngology |
| Orthopedics | Urology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate how treatments for malignant tumor had effect on continuing pregnancy, delivery, puerperium, and fetus.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mother:treatment for cancer, maternal puerperial health condition
Neonats:gestational-age, body weight, pH of umbilical arterial blood, admission to NICU, presence of disorder
Key secondary outcomes
Overall survival, Reccurent Rate, Progression Free Survival
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients of cancer in pregnancy diagnosed from Jan. 1, 2014 to Dec.31, 2014
Key exclusion criteria
1)Patients who weren't provided a definitive diagnosis
2)Patients reject entering this trial
3)Patients under 18 years old
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Kobayashi |
Organization
Mie University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174, Edobashi, Tsu city, Mie, Japan
TEL
059-232-1111
og.koba@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayu Omori |
Organization
Mie University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174, Edobashi, Tsu city, Mie, Japan
TEL
059-232-1111
Homepage URL
mayu-o@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Mie University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 24 | 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
| 2015 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2015 | Year | 05 | Month | 27 | Day |
Last modified on
| 2018 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020458
