UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008192 |
|---|---|
| Receipt number | R000009654 |
| Scientific Title | Evaluation of the usefulness and validity of the expanded criteria for primary screening of Lynch syndrome |
| Date of disclosure of the study information | 2012/06/22 |
| Last modified on | 2015/06/18 10:58:55 |
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Basic information
Public title
Evaluation of the usefulness and validity of the expanded criteria for primary screening of Lynch syndrome
Acronym
Evaluation of the expanded screening criteria for Lynch syndrome
Scientific Title
Evaluation of the usefulness and validity of the expanded criteria for primary screening of Lynch syndrome
Scientific Title:Acronym
Evaluation of the expanded screening criteria for Lynch syndrome
Region
| Japan |
Condition
Condition
Colorectal cancer, endometrial cancer and colorectal polyps
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To examine the usefulness and validity of the expanded screening criteria developed for the sensitive screening of Lynch syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity of screening criteria for patients with Lynch syndrome
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
| Other |
Interventions/Control_1
MSI test
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
I. Colorectal or endometrial cancer patients in the following situations:
1. Diagnosed at less than 50 years of age.
2. Presence of synchronous, metachronous Lynch syndrome (LS) associated tumors (according to the expanded criteria) *1, regardless of age.
3. Presence of adenocarcinomas from the lower uterine segment (LUS)
4. Colorectal or endometrial cancer with the MSI-H histology*2 diagnosed in a patient who is less than 60 years of age.
5. Colorectal or endometrial cancer diagnosed in one or more first-degree relatives with an LS-related tumor, with one of the cancers being diagnosed under age 50 years.
6. Colorectal or endometrial cancer diagnosed in two or more first- or second-degree relatives with LS-related tumors, regardless of age.
*1 Lynch syndrome (LS) associated tumors (expanded criteria) :
carcinomas of colorectum, endometrium, stomach, ovaries, pancreas, ureter and renal pelvis, biliary tract, small bowel, breast, urinary bladder and brain (usually glioblastoma as seen in Turcot syndrome), sebaceous gland adenomas and keratoacanthomas in Muir-Torre syndrome
*2 MSI histology:
Colorectal cancer; Presence of tumor infiltrating lymphocytes, Crohn's-like lymphocytic reaction, mucinous/signet-ring differentiation, or medullary growth pattern.
Endometrial cancer; Presence of dense peritumoural lymphocytes apparent at low power magnification, prominent tumour infiltrating lymphocytes (greater than 40 tumour infiltrating lymphocytes per 10 high power fields), and tumour heterogeneity defined as two morphologically distinct tumour populations juxtaposed but not intimately mixed with each other, and each constituting at least 10% of the tumour volume.
II. Patients with multiple colorectal polyps who fulfill at least one of the above conditions 1-6
Key exclusion criteria
Patient whose infromed concent was not obtained
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Taguchi |
Organization
Midtown Clinic Medical Corporation
Division name
Center for Advanced Medical Science and Technology
Zip code
Address
Tokyo Midtown Tower 6F, 9-7-1 Akasaka, Minato-ku, Tokyo 107-6206 Japan
TEL
03-5413-0080
j-taguchi@tokyomidtown-mc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ruriko Horio |
Organization
Midtown Clinic Medical Corporation
Division name
Center for Advanced Medical Science and Technology
Zip code
Address
Tokyo Midtown Tower 6F, 9-7-1 Akasaka, Minato-ku, Tokyo 107-6206 Japan
TEL
03-5413-0080
Homepage URL
r-horio@amcare.co.jp
Sponsor or person
Institute
Midtown Clinic Medical Corporation
Institute
Department
Personal name
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
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
| 2012 | Year | 06 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | 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
| 2012 | Year | 06 | Month | 18 | Day |
Last modified on
| 2015 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009654
