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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037962
Receipt No. R000043271
Scientific Title Cross-sectional and longitudinal assessment of patient-reported outcome according to treatment options in patients with asymptomatic papillary thyroid microcarcinoma
Date of disclosure of the study information 2019/10/01
Last modified on 2019/09/08

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Basic information
Public title Cross-sectional and longitudinal assessment of patient-reported outcome according to treatment options in patients with asymptomatic papillary thyroid microcarcinoma
Acronym Patient-reported outcome in asymptomatic papillary thyroid microcarcinoma
Scientific Title Cross-sectional and longitudinal assessment of patient-reported outcome according to treatment options in patients with asymptomatic papillary thyroid microcarcinoma
Scientific Title:Acronym PRO/PTMC
Region
Japan

Condition
Condition Papillary thyroid carcinoma
Classification by specialty
Endocrine surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess cross-sectional patient-reported outcome in patients with very low-risk papillary thyroid microcarcinoma (cT1aN0M0) accoding to treatment option including active surveillance, immediate conventional surgery and immediate endoscopic surgery.
Basic objectives2 Others
Basic objectives -Others To assess longitudinal patient-reported outcome in patients with very low-risk papillary thyroid microcarcinoma (cT1aN0M0) accoding to treatment option including active surveillance, immediate conventional surgery and immediate endoscopic surgery.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Patient-reported outcome cross-sectionally assessed by SF-36 and STAI for patients with asymptomatic papillary thyroid carcinoma (cT1aN0M0) who have already underwent active surveillance, immediate conventional surgery and immediate endoscopic surgery since 1995.
Key secondary outcomes Longitudinal patient-reported outcome prospectively assessed by SF-36 and STAI for patients with asymptomatic papillary thyroid carcinoma (cT1aN0M0) who start to undergo active surveillance, immediate conventional surgery and immediate endoscopic surgery from now on.

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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients with very low-risk papillary thyroid microcarcinoma (cT1aN0M0) diagnosed by ultrasonography and fine needle aspiration biopsy
Key exclusion criteria Patients younger than 18 years old.
Target sample size 550

Research contact person
Name of lead principal investigator
1st name Iwao
Middle name
Last name Sugitani
Organization Nippon Medical School
Division name Department of Endocrine Surgery
Zip code 113-8603
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 0338222131
Email isugitani@nms.ac.jp

Public contact
Name of contact person
1st name Iwao
Middle name
Last name Sugitani, MD, PhD (Endocrine Surgery)
Organization Nippon Medical School
Division name Department of Endocrine Surgery
Zip code 113-8603
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 0338222131
Homepage URL
Email isugitani@nms.ac.jp

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Endocreine Surgery, Tokyo Women's Medical University
Division of Head and Neck, Cancer Institute Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board, Nippon Medical School
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel 0338222131
Email nms_fuzokurinri@nms.ac.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 日本医科大学付属病院(東京都)、東京女子医科大学附属病院(東京都)、がん研究会有明病院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 29 Day
Date of IRB
2019 Year 07 Month 01 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2027 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Preinitiation

Management information
Registered date
2019 Year 09 Month 08 Day
Last modified on
2019 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043271

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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