Concordance in MRI and Pathology Diagnosis of Extranodal Tumour Deposits

Concordance in MRI and Pathology Diagnosis of Extranodal Tumour Deposits - COMET

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51107

Enrollment

100

Registered

2021-06-10

Start date

2022-02-25

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

Colorectal cancer

Interventions

Correlation of diagnostic tests: MRI/CT scans will be correlated with samples from the resection specimen that are photographed on a numbered grid.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Primary adenocarcinoma of the colon or rectum (proven by biopsy) - Amenable to surgical resection. - Disease spread assessed on CT and/or MRI - Patients having primary surgery and those undergoing neoadjuvant treatment will be included. - All must have had a baseline staging MRI/CT and those undergoing neoadjuvant therapy must also have had a post-treatment MRI. - Patients aged 18 years and over

Exclusion criteria

Exclusion criteria: - Under the age of 18 years - Unable to give informed consent. - Recurrent tumours - Synchronous tumours - Unable to have an MRI/CT scan (e.g pacemaker, contrast allergy, severe claustrophobia)

Design outcomes

Primary

Measure	Time frame
The accuracy of diagnosing tumor deposits on MRI/CT by comparing radiologically found tumor deposits withreported tumor deposits and 'equivocal' nodules without evidence of lymph node architecture on pathology.	—

Secondary

Measure	Time frame
1. The concordance between MRI/CT and pathology 2. The overall survival, disease free survival at 1, 3 and 5 years as well a time to recurrence. This will be reported in four groups of patients: TD+/LN+, TD+/LN-, TD-/LN+, TD-/LN-, and it will be done seperately for both MRI/CT and pathology diagnosis. 3. The prevalence of EMVI and its association with TD, LN status, LN yield, T stage, CRM status 4. The 'L' and 'E' scores for the nodules indicated on MRI/CT 5. The interobserver agreement between local radiologist and central reviewing radiologist 6. The interobserver agreement in pathology reporting between the local pathologists and the central reviewing pathologist. 7. The presence of TD on the pre-treatment MRI for rectal cancer patients who underwent neoadjuvant therapy 8. The concordance in molecular pathology between primary tumour and TD, LNM, and distant metastases 9. The correlation between the finding of a nodular invasive border on MRI/CT and pathology findings of tumour budding	—

Measure

Time frame

1. The concordance between MRI/CT and pathology 2. The overall survival, disease free survival at 1, 3 and 5 years as well a time to recurrence. This will be reported in four groups of patients: TD+/LN+, TD+/LN-, TD-/LN+, TD-/LN-, and it will be done seperately for both MRI/CT and pathology diagnosis. 3. The prevalence of EMVI and its association with TD, LN status, LN yield, T stage, CRM status 4. The 'L' and 'E' scores for the nodules indicated on MRI/CT 5. The interobserver agreement between local radiologist and central reviewing radiologist 6. The interobserver agreement in pathology reporting between the local pathologists and the central reviewing pathologist. 7. The presence of TD on the pre-treatment MRI for rectal cancer patients who underwent neoadjuvant therapy 8. The concordance in molecular pathology between primary tumour and TD, LNM, and distant metastases 9. The correlation between the finding of a nodular invasive border on MRI/CT and pathology findings of tumour budding

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)