UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

Sensitivity of screening criteria for patients with Lynch syndrome

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

j-taguchi@tokyomidtown-mc.jp

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

Email

r-horio@amcare.co.jp

Institute

Midtown Clinic Medical Corporation

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

06

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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