UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055711 |
|---|---|
| Receipt number | R000063666 |
| Scientific Title | A Prospective Study on the Effects of Thyrotropin Suppression Therapy in Active Surveillance for Low-Risk Papillary Thyroid Carcinoma Patients |
| Date of disclosure of the study information | 2024/10/03 |
| Last modified on | 2024/10/03 00:16:36 |
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Basic information
Public title
A Prospective Study on the Effects of Thyrotropin Suppression Therapy in Active Surveillance for Low-Risk Papillary Thyroid Carcinoma Patients
Acronym
Thyrotropin Suppression Therapy for Low-Risk Papillary Thyroid Carcinoma undergoing Active Surveillance
Scientific Title
A Prospective Study on the Effects of Thyrotropin Suppression Therapy in Active Surveillance for Low-Risk Papillary Thyroid Carcinoma Patients
Scientific Title:Acronym
LT4 suppression for AS patients
Region
| Japan |
Condition
Condition
Papillary thyroid carcinoma
Classification by specialty
| Endocrine surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Enroll patients who chose active surveillance for low-risk papillary thyroid carcinoma through shared decision-making, some patients will undergo thyrotropin suppression therapy, while others will not. We will assess the progression rate and quality of life.
Basic objectives2
Others
Basic objectives -Others
Enroll patients who chose active surveillance for low-risk papillary thyroid carcinoma through shared decision-making, some patients will undergo thyrotropin suppression therapy, while others will not. We will assess the progression rate and quality of life.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression rate (tumor growth, occurrence of lymph node metastasis) compared between the group undergoing thyrotropin suppression therapy and the group not receiving it for patients who chose active surveillance (AS) for low-risk papillary thyroid carcinoma (PTC) after October 2024 through shared decision-making (SDM).
Key secondary outcomes
Incidence of adverse events and quality of life (QoL) compared between the group undergoing thyrotropin suppression therapy and the group not receiving it for patients who chose AS for low-risk PTC after October 2024 through SDM.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with low-risk PTC diagnosed by ultrasonography and fine needle aspiration biopsy, with a primary tumor size of 15 mm or less, who chose AS after receiving sufficient explanation and giving informed consent regarding the management strategy
Key exclusion criteria
Patients with evident extrathyroidal extension, lymph node metastasis, or distant metastasis
Patients with the following comorbidities: Graves' disease, other forms of thyrotoxicosis, ischemic heart disease, arrhythmia, or osteoporosis
Patients already undergoing AS for papillary thyroid carcinoma
Patients deemed to lack the capacity to make decisions regarding participation in the study
Other patients considered unsuitable for participation in the study by the principal investigator or co-investigators
Target sample size
700
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
Kuma Hospital
Shinshu University
Yamashita Thyroid Hospital
Nagoya University Hospital
The Third Hospital of Jikei University School of Medicine
Kobe University Hospital
Showa University Northern Yokohama Hospital
Hiratsuka Kyosai Hospital
Gunma University Hospital
Fukushima Medical University
Tokyo Women's Medical University
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（東京都）、隈病院（兵庫県）、信州大学（長野県）、やました甲状腺病院（福岡県）、名古屋大学医学部附属病院（愛知県）、東京慈恵会医科大学附属第三病院（東京都）、神戸大学医学部附属病院（兵庫県）、昭和大学横浜市北部病院（神奈川県）、平塚共済病院（神奈川県）、群馬大学医学部附属病院（群馬県）、福島県立医科大学（福島県）、東京女子医科大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 03 | 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
| 2024 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2037 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preinitiation
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2024 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063666
