NCT04232020

Brief Summary

To compare the Idylla microsatellite instability test versus mismatch repair immunohistochemistry (IHC) in gastric adenocarcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

February 7, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2020

Completed
Last Updated

October 8, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

January 6, 2020

Last Update Submit

October 6, 2020

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Idylla MSI test using Idylla MSI Cartridges to assess suitability

    MMR IHC panels will be passed to the histopathology team for interpretation. Cases will be interpreted and results will be determined by either a) loss of staining or b) no loss of staining of any individual antibody

    6 months

Interventions

Mismatch repairDIAGNOSTIC_TEST

MSI testing using Biocartis Idylla and MMR immunohistochemistry

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study involves the use of pre-existing tissue samples and has no patient participation apart from the use of the existing sample. Only samples that have been identified with an adenocarcinoma diagnosis and with an adequate amount of tissue sample available will be used in the study.

You may qualify if:

  • Patient consent
  • Adequate tissue including adequate tumour burden
  • Diagnosis of adenocarcinoma in this biopsy

You may not qualify if:

  • No patient consent
  • Inadequate tissue or block not present in archive
  • No adenocarcinoma in biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Cornwall Hospital

Truro, Cornwall, TR1 3LQ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

formalin fixed paraffin processed tissue

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

DNA Mismatch Repair

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

DNA RepairBiochemical PhenomenaChemical PhenomenaGenetic Phenomena

Study Officials

  • Mary Jones

    Senior Biomedical Scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 18, 2020

Study Start

February 7, 2020

Primary Completion

July 31, 2020

Study Completion

August 5, 2020

Last Updated

October 8, 2020

Record last verified: 2020-01

Locations

GB(1)