UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of cytometry for diagnosis of peritomearl carcinomatosis
Title of the study (Brief title)	Efficacy of cytometry for diagnosis of peritomearl carcinomatosis
Region	Japan

Condition
Condition	gynecologic malignancy
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To develop a new objective indicators that improve diagnostic accuracy of peritoneal cytology.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	sensitivity and specificity of cytometry for peritoneal cytology
Key secondary outcomes

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	people who needs endometrial cytology
Key exclusion criteria	under 20 yo, lack of consent capacity
Target sample size	100

Research contact person
Name of lead principal investigator	Tokunaga Hideki
Organization	Tohoku University
Division name	Gynecology
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7254
Email	tokunagahideki@med.tohoku.ac.jp

Public contact
Name of contact person	Tokunaga Hideki
Organization	Tohoku University
Division name	Gynecology
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7254
Homepage URL
Email	tokunagahideki@med.tohoku.ac.jp

Sponsor
Institute	Dept. of gynecology, Tohoku University Hospital
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study Design: cohort study Subject of recruitment method: patients need cytologic diagnosis of ascites Recruitment period: March-April/2016 Item measure: CPIx, CPIx

Management information
Registered date	2016 Year 01 Month 10 Day
Last modified on	2019 Year 01 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023689