UMIN-CTR Clinical Trial

Basic information
Public title	Cohort Study to Explore the Therapeutic Effect of Lenvatinib on Differentiated Thyroid Cancer
Acronym	COLLECT (Cohort Study of Lenvatinib (LEnvima) in Differentiated Cancer of Thyroid)
Scientific Title	Cohort Study to Explore the Therapeutic Effect of Lenvatinib on Differentiated Thyroid Cancer
Scientific Title:Acronym	COLLECT (Cohort Study of Lenvatinib (LEnvima) in Differentiated Cancer of Thyroid)
Region	Japan

Condition
Condition	Differentiated Thyroid Cancer
Classification by specialty	Hematology and clinical oncology Endocrine surgery Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This is a prospective observational study involving curatively unresectable, RAI-refractory and progressive DTC and will undergo treatment with novel molecularly targeted drug lenvatinib in actual clinical settings while medical information on prognostic factors is collected, including detailed information on previous treatment and information on the content of other treatments or rechallenge with lenvatinib after the study treatment ends.
Basic objectives2	Others
Basic objectives -Others	QOL
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Overall Survival
Key secondary outcomes	1)Time to Treatment Failure 2)Time to Failure of Strategy 3)Progression-Free Survival with clinical Progressive Disease 4)Response Rate 5)QOL survey 6)Safety 7)Patient Reports

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patient with curatively unresectable, RAI-refractory and progressive DTC who is determined suitable for treatment with lenvatinib 2)Patient who began treatment with lenvatinib after this study passed review by the facility's review committee 3)Patient who has given consent to participate in the study
Key exclusion criteria	1)Patient deemed unsuitable to participate in this study by the attending physician
Target sample size	300

Research contact person
Name of lead principal investigator	1st name (1)Makoto (2)Tsuneo Middle name Last name (1)Tahara, (2)Imai
Organization	(1)National Cancer Center Hospital East, (2)National Hospital Organization Higashinagoya National Hospital
Division name	(1)Head and Neck Medical Oncology, (2)President
Zip code	(1)277-8577, (2)465-8620
Address	(1)6-5-1 Kashiwanoha, Kashiwa-shi, Chiba 277-8577, Japan (2)5-101 Umemorizaka, Meito-ku Nagoya-shi, Aichi 465-8620, Japan
TEL	(1)04-7133-1111(2)052-801-1151
Email	matahara@east.ncc.go.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Yamao
Organization	Public Health Research Foundation
Division name	Comprehensive Support Project for Oncology Research (CSPOR)
Zip code	169-0051
Address	1-1-7 Nishi-waseda, Shinjuku-ku, Tokyo 169-0051, Japan
TEL	03-5287-2636
Homepage URL
Email	cspor-dtc@csp.or.jp

Sponsor
Institute	Public Health Research Foundation
Institute
Department

Funding Source
Organization	Eisai 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	No
Address	No
Tel	03-3542-2511
Email	no@mail

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

愛知医科大学，愛知県がんセンター中央病院，伊勢赤十字病院，伊藤病院，医療法人東札幌病院，岩手県立中央病院，内丸病院，愛媛大学医学部附属病院，大垣市民病院，大阪医科大学，大阪急性期・総合医療センター，大阪警察病院，大阪市立大学大学院，岡崎市民病院，岡山医療センター，岡山大学病院，香川大学医学部附属病院，鹿児島医療センター，鹿児島大学，神奈川県立がんセンター，金沢医科大学，金沢大学附属病院，川崎医科大学附属病院，がん研有明病院，関西医科大学総合医療センター，関西医科大学附属病院，関西電力病院，北里大学病院，紀南病院，岐阜大学医学部附属病院，九州医療センター，九州大学病院，九州大学病院別府病院，京都大学医学部附属病院，京都府立医科大学，近畿大学医学部奈良病院，近畿大学医学部附属病院，草津総合病院，隈病院，熊本大学医学部附属病院，群馬大学医学部附属病院，慶應義塾大学医学部，恵佑会札幌病院，県立広島病院，高知医療センター，神戸市立医療センター中央市民病院，国立がん研究センター東病院，国立病院機構名古屋医療センター，埼玉医科大学国際医療センター，JCHO九州病院，滋賀医科大学，四国がんセンター，自治医科大学附属病院，昭和大学病院，昭和大学横浜市北部病院，信州大学医学部附属病院，千葉大学医学部附属病院，地方独立行政法人那覇市立病院，筑波大学附属病院，手稲渓仁会病院，東京医科大学病院，東京慈恵会医科大学，東京大学医学部附属病院，東邦大学医療センター大森病院，東北大学病院，独立行政法人国立病院機構東名古屋病院，獨協医科大学越谷病院，鳥取大学医学部，名古屋大学医学部附属病院，奈良県立医科大学附属病院，新潟大学大学院医歯学総合研究科，新潟大学医歯学総合研究科，日本医科大学，浜松医科大学，兵庫県立がんセンター，弘前大学医学部，広島大学，福井大学医学部附属病院，福島県立医科大学，北海道大学病院，北光記念病院，三重大学医学部附属病院，三井記念病院，山形県立中央病院，山梨大学医学部附属病院，横浜市立大学附属病院，和歌山県立医科大学附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 26 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	265
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	No longer recruiting
Date of protocol fixation	2016 Year 06 Month 22 Day
Date of IRB	2016 Year 06 Month 22 Day
Anticipated trial start date	2016 Year 08 Month 16 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 02 Month 28 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information	All patients who has given consent to participate in the study during from 1 July 2016 to 31 Dec. 2017.

Management information
Registered date	2016 Year 05 Month 09 Day
Last modified on	2020 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025625