UMIN-CTR Clinical Trial

Basic information
Public title	A case series study of bevacizumab-associated fistula formation in cervical cancer patients.
Acronym	A case series study of bevacizumab-associated fistula formation in cervical cancer patients.
Scientific Title	A case series study of bevacizumab-associated fistula formation in cervical cancer patients.
Scientific Title:Acronym	A case series study of bevacizumab-associated fistula formation in cervical cancer patients.
Region	Japan

Condition
Condition	Advanced or recurrent cervical cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To provide safety information associated with bevacizumab treatment in cervical cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Characteristics and prior treatments of patients who developed fistulas after administration of bevacizumab.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	6 patients who developed fistulas during Avastin Special Drug Use Surveillance (advanced or recurrent cervical cancer) conducted between June 2016 and January 2018.
Key exclusion criteria	None
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Sugiyama
Organization	St. Mary's Hospital
Division name	Department of Obstetrics and Gynecology
Zip code	830-8543
Address	422 Tsubukuhonmachi, Kurume,Fukuoka 830-8543,Japan
TEL	0942-35-3322
Email	to-sugiyama@st-mary-med.or.jp

Public contact
Name of contact person	1st name Co., Ltd. Middle name Last name Chugai Pharmaceutical
Organization	Medical Affairs Div.
Division name	Medical Science Dept.
Zip code	103-8324
Address	1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku,Tokyo 103-8324,Japan
TEL	03-3273-0866
Homepage URL
Email	cma-clinicaltrial@chugai-pharm.co.jp

Sponsor
Institute	St. Mary's Hospital and Chugai Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Non-profit organization MINS
Address	15-14 dogenzaka 1-Chome,shibuya-ku,tokyo,Japan
Tel	03-6416-1868
Email	Npo-mins@j-irb.com

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	2020 Year 04 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	Enrolling by invitation
Date of protocol fixation	2020 Year 01 Month 22 Day
Date of IRB	2020 Year 01 Month 22 Day
Anticipated trial start date	2020 Year 04 Month 27 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Case series study

Management information
Registered date	2020 Year 04 Month 03 Day
Last modified on	2020 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045617

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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