'Early detection of hepatic metastasis in follow-up high-risk colorectal carcinoma*

'Early detection of hepatic metastasis in follow-up high-risk colorectal carcinoma* - EDAM study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48841

Enrollment

174

Registered

2019-10-15

Start date

2020-06-19

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

liver metastasis

Interventions

Patients in the control group will undergo US at regular intervals (6,12,24 and 36 months after surgery) as part of a common care. Besides these US*s the intervention group will also undergo a short

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: High risk colorectal carcinoma

Exclusion criteria

Exclusion criteria: - MRI incompatible devices - Age > 80 years - Not mastering the Dutch language (given the questionnaires) - Pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
Primary study parameter/endpoint 1. Time to diagnosis recurrent liver metastasis (LM-2) in months starting from postoperative control (=randomization);TRLM.	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints 2. Time to diagnosis of first liver metastasis (LM-1) in months starting from postoperative control (= randomization);TFLM. 3. Time between first postoperative control and diagnosis of first liver metastasis (LM-1); liver metastasis free survival 1 (LMFS-1). 4. Time between diagnosis LM-1 and diagnosis LM-2 in months; liver metastasis free survival 2 (LMFS-2). 5. The proportion of patients who are potentially eligible for curative therapy when detecting LM-1. 6. 5 year survival. 7. Anxiety and quality of life (HADS-A (anxiety score), SF-36 (QOL), QLQ-C30). 8. Sensitivity and specificity of both US as reduced MRI liver protocol for detection of liver metastasis.	—

Measure

Time frame

Secondary study parameters/endpoints 2. Time to diagnosis of first liver metastasis (LM-1) in months starting from postoperative control (= randomization);TFLM. 3. Time between first postoperative control and diagnosis of first liver metastasis (LM-1); liver metastasis free survival 1 (LMFS-1). 4. Time between diagnosis LM-1 and diagnosis LM-2 in months; liver metastasis free survival 2 (LMFS-2). 5. The proportion of patients who are potentially eligible for curative therapy when detecting LM-1. 6. 5 year survival. 7. Anxiety and quality of life (HADS-A (anxiety score), SF-36 (QOL), QLQ-C30). 8. Sensitivity and specificity of both US as reduced MRI liver protocol for detection of liver metastasis.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)