UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022243 |
|---|---|
| Receipt number | R000025625 |
| Scientific Title | Cohort Study to Explore the Therapeutic Effect of Lenvatinib on Differentiated Thyroid Cancer |
| Date of disclosure of the study information | 2016/05/26 |
| Last modified on | 2020/11/11 14:16:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
cspor-dtc@csp.or.jp
Sponsor or person
Institute
Public Health Research Foundation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025625
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
