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Evaluation of the usefulness and validity of the expanded criteria for primary screening of Lynch syndrome

Evaluation of the usefulness and validity of the expanded criteria for primary screening of Lynch syndrome - Evaluation of the expanded screening criteria for Lynch syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008192
Enrollment
10
Registered
2012-06-22
Start date
2012-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer, endometrial cancer and colorectal polyps

Interventions

MSI test

Sponsors

Midtown Clinic Medical Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Patient whose infromed concent was not obtained

Design outcomes

Primary

MeasureTime frame
Sensitivity of screening criteria for patients with Lynch syndrome

Countries

Japan

Contacts

Public ContactRuriko Horio

Midtown Clinic Medical Corporation Center for Advanced Medical Science and Technology

r-horio@amcare.co.jp03-5413-0080

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026