UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study of the detection and monitoring of circulating tumor cells in patients with operable breast cancer
Acronym	Circulating tumor cells in peripheral and drainage vein blood of operable breast cancer patients
Scientific Title	A prospective study of the detection and monitoring of circulating tumor cells in patients with operable breast cancer
Scientific Title:Acronym	Circulating tumor cells in peripheral and drainage vein blood of operable breast cancer patients
Region	Japan

Condition
Condition	Operable breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the possibility of isolation of CTC in drainage venous blood, and the potential of CTC in the monitoring of operable breast cancer.
Basic objectives2	Others
Basic objectives -Others	Isolation and clinical utility of CTCs in patients with operable breast cancer.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Distribution of CTC in periferal and tumor drainage venous blood. Clinical utility of CTC as a biomarker for monitoring of disease status.
Key secondary outcomes	Assessment of the molecular characteristics of CTC. Association between the amount of CTC and clinical course.

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	Male and Female
Key inclusion criteria	1) Patients with more than 20 years. 2) Patients who undergo breast surgery with axillary lymph node dissection for breast cancer determined by histological or cytological diagnosis. 3) Patients providing written informed consent.
Key exclusion criteria	1) Patient with other active cancer (except cancer treated without recurrence in more than 5 years and after carcinoma complete excision in situ) 2) Any other patients who are regarded as unsuitable for this study by the investigators.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Masaya Middle name Last name Hattori
Organization	Aichi Cancer Center Hospital
Division name	Department of Breast Oncology
Zip code	4648681
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, JAPAN
TEL	0527626111
Email	mhattori@aichi-cc.jp

Public contact
Name of contact person	1st name Masaya Middle name Last name Hattori
Organization	Aichi Cancer Center Hospital
Division name	Department of Breast Oncology
Zip code	464-8681
Address	1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, JAPAN
TEL	0527626111
Homepage URL
Email	mhattori@aichi-cc.jp

Sponsor
Institute	Department of Breast Oncology, Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization	Department of Breast Oncology, Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Aichi Cancer Center Research Institute
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Aichi Cancer Center
Address	1-1 Kanokoden Chikusa-ku, Nagoya Japan
Tel	0527626111
Email	y_hasegawa@aichi-cc.jp

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	愛知県がんセンター中央病院

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 31 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	Main results already published
Date of protocol fixation	2016 Year 08 Month 15 Day
Date of IRB	2016 Year 10 Month 12 Day
Anticipated trial start date	2016 Year 10 Month 25 Day
Last follow-up date	2021 Year 10 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2017 Year 07 Month 28 Day
Last modified on	2020 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032532