UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051584 |
|---|---|
| Receipt number | R000058810 |
| Scientific Title | Establishment of diagnosis and treatment system for rare cancers in healthy population |
| Date of disclosure of the study information | 2023/07/14 |
| Last modified on | 2024/02/05 18:45:26 |
* 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
Establishment of diagnosis and treatment system for rare cancers in healthy population
Acronym
RareScan study
Scientific Title
Establishment of diagnosis and treatment system for rare cancers in healthy population
Scientific Title:Acronym
RareScan study
Region
| Japan |
Condition
Condition
Intrahepatic cholangiocarcinoma and small bowel cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Establish a medical treatment system from diagnosis to treatment of rare cancers for healthy people.
Basic objectives2
Others
Basic objectives -Others
Establish a medical treatment system from diagnosis to treatment of rare cancers for healthy people.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of intrahepatic cholangiocarcinoma or small bowel cancer diagnosed in screening-positive patients
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Kei inclusion criteria for Intrahepatic Cholangiocarcinoma
1. Elevated serum alkaline phosphatase (ALP) and intrahepatic bile duct dilation or hepatic mass detected on abdominal ultrasonography
2. Serum Carbohydrate Antigen 19-9 above upper limit of normal
3. Intrahepatic bile duct dilation or hepatic mass detected on abdominal ultrasonography Excluding obvious hepatic hemangioma
Key inclusion criteria for Small Bowel Cancer
1. Positive fecal occult blood for 2 consecutive years.
2. Positive fecal occult blood and anemia
Key exclusion criteria
None.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Furuse |
Organization
Kanagawa Cancer Center
Division name
Gastroenterology
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama-shi, Kanagawa
TEL
0455202222
junjifuruse@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Tozuka |
Organization
Kanagawa Cancer Center
Division name
Gastroenterology
Zip code
2418515
Address
2-3-2 Nakao, Asahi-ku, Yokohama-shi, Kanagawa
TEL
0455202222
Homepage URL
tozuka.0x00m@kanagawa-pho.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cancer Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Cancer Center
Address
2-3-2 Nakao, Asahi-ku, Yokohama-shi, Kanagawa
Tel
0455202222
clinical_trials@kcch.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will focus on intrahepatic cholangiocarcinoma and small bowel cancer as an effort to establish a treatment system from early diagnosis to provision of effective treatment for rare cancers and to improve prognosis among healthy people in Kanagawa Prefecture who have undergone medical checkups and physical examinations, and will conduct clinical trials to establish a screening system for early diagnosis.
Management information
Registered date
| 2023 | Year | 07 | Month | 11 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058810
