UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005785 |
|---|---|
| Receipt number | R000006823 |
| Scientific Title | DNA mismatch repair (MMR) protein immunohistchemistry of hereditary non-polyposis colorectal cancer (HNPCC) related tumors and genetic analysis of MMR gene mutations. |
| Date of disclosure of the study information | 2011/06/29 |
| Last modified on | 2011/06/15 22:17:11 |
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Basic information
Public title
DNA mismatch repair (MMR) protein immunohistchemistry of hereditary non-polyposis colorectal cancer (HNPCC) related tumors and genetic analysis of MMR gene mutations.
Acronym
DNA mismatch repair status of HNPCC related tumors
Scientific Title
DNA mismatch repair (MMR) protein immunohistchemistry of hereditary non-polyposis colorectal cancer (HNPCC) related tumors and genetic analysis of MMR gene mutations.
Scientific Title:Acronym
DNA mismatch repair status of HNPCC related tumors
Region
| Japan |
Condition
Condition
HNPCC related tumor
Classification by specialty
| Medicine in general | Gastroenterology | Hematology and clinical oncology |
| Gastrointestinal surgery | Obstetrics and Gynecology | Dermatology |
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This project is aiming to screen HNPCC or HNPCC suspicious patients by immunohistchemistry of tumors for loss of expression of MMR protein. Then, identified patients are surveyed according to a recommended guideline. Clinical features should be analyzed with the IHC results. We will add genetic or epigenetic analysis of MMR genes to MMR protein deficient tumors to identify the responsible alterations
Basic objectives2
Others
Basic objectives -Others
Diagnosis by immunohistchemical or genetic analyses
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Screening of HNPCC related tumors by IHC for loss of MMR protein expression and observation of the clinical features assciated with MMR deficiency.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
IHC of MMR proteins, genetic or epigenetic analyses of MMR genes
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients fulfilled Amsterdam criteria I, II or Bethesda guideline.
Patients suspected HNPCC or related syndrome such as Muir-Torre syndrome or Turcot syndrome.
Patients with written informed consent form.
Key exclusion criteria
Patients with no available sample.
Patients without written informed consent form.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chikashi Ishioka |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Department of Clinical Oncology
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Shimodaira |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Department of Clinical Oncology
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
TEL
Homepage URL
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Department of Clinical Oncology, Institute of Development, Aging and Cancer, Tohoku University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 06 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2008 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 15 | Day |
Last modified on
| 2011 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006823
