UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037962 |
|---|---|
| Receipt number | 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 | 2024/03/13 07:18:36 |
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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
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
isugitani@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
10.1007/s00268-022-06786-5
Number of participants that the trial has enrolled
Results
Hiroko Kazusaka, Iwao Sugitani, Kazuhisa Toda, Masaomi Sen, Marie Saito, Ryuta Nagaoka, Yusaku Yoshida
Patient-Reported Outcomes in Patients with Low-Risk Papillary Thyroid Carcinoma: Cross-Sectional Study to Compare Active Surveillance and Immediate Surgery
World J Surg 2022
Results date posted
| 2024 | Year | 03 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 10 | Month | 25 | Day |
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
| 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
Enrolling by invitation
Management information
Registered date
| 2019 | Year | 09 | Month | 08 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043271
