![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000042618 |
Receipt No. | R000048635 |
Scientific Title | The usefulness of screening with direct forward viewing radial EUS and MRI for high risk individual with family history of pancreatic cancer and hereditary pancreatic cancer syndrome. |
Date of disclosure of the study information | 2020/12/01 |
Last modified on | 2020/12/01 |
Basic information | ||
Public title | The usefulness of screening with direct forward viewing radial EUS and MRI for high risk individual with family history of pancreatic cancer and hereditary pancreatic cancer syndrome. | |
Acronym | Screening for HRI with family history of PC | |
Scientific Title | The usefulness of screening with direct forward viewing radial EUS and MRI for high risk individual with family history of pancreatic cancer and hereditary pancreatic cancer syndrome. | |
Scientific Title:Acronym | Screening for HRI with family history of PC | |
Region |
|
Condition | ||
Condition | Pancreatic cancer | |
Classification by specialty |
|
|
Classification by malignancy | Malignancy | |
Genomic information | YES |
Objectives | |
Narrative objectives1 | examine the frequency of pancreatic cancer and pancreatic cancer high risk factors such as pancreatic cyst, main pancreatic duct dilation, and early chronic pancreatitis |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Incidence of pancreatic diseases such as pancreatic cancer and pancreatic endocrine tumors |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1)Individuals with at least one affected first degree relative(FDR)
2)Individuals with Hereditary pancreatitis (HP), Hereditary breast ovarian cancer syndrome (HBOC), Peutz-Jeghers syndrome,Familial atypical multiple melanoma (FAMMM), Fereditary nonpolyposis colon cancer (HNPCC), familial adenomatous polyposis (FAP) |
|||
Key exclusion criteria | Cases who cannot receive planned test(ex.
total gastrectomy, Claustrophobia) |
|||
Target sample size | 360 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Wakayama Medical University | ||||||
Division name | Second Department of Internal Medicine | ||||||
Zip code | 641-8509 | ||||||
Address | 811-1 Kimiidera, Wakayama City | ||||||
TEL | 073-447-2300 | ||||||
rashida@wakayama-med.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Wakayama Medical University | ||||||
Division name | Second Department of Internal Medicine | ||||||
Zip code | 641-8509 | ||||||
Address | 811-1 Kimiidera, Wakayama City | ||||||
TEL | 073-447-2300 | ||||||
Homepage URL | |||||||
ninai@wakayama-med.acj.jp |
Sponsor | |
Institute | Wakayama Medical University |
Institute | |
Department |
Funding Source | |
Organization | none |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Research Ethics Committee of Wakayama Medical University |
Address | 811-1 Kimiidera, Wakayama, Wakayama Prefecture |
Tel | 073-447-2300/+81-73-447-2300 |
wa-rinri@wakayama-med.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 |
Other administrative information | |||||||
Date of disclosure of the study information |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | none
|
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048635 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |