Clinical trial · Interventional
A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma
A Prospective Randomized Multicenter Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of Stage IIb-c and III Cutaneous Malignant Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
It is not known whether radiological assessments during follow up after surgery for high risk melanoma improve survival. Since radiological examinations are resource demanding, could inflict worry and cause irradiation exposure it is an important question to address. With the introduction of effective medical treatments for malignant melanoma patients, there is a tendency to introduce radiological assessments despite the lack of evidence.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT or PET scans | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Routine follow up
- description
- Follow up according to national guidelines.
- type
- EXPERIMENTAL
- label
- Radiological assessments
- description
- Radiological assessments (CT or PET scans) at 5 occasions during 3 years.
- interventionNames
- Procedure: CT or PET scans
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- At 5 years
- description
- Measured from date of inclusion
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years of age. * Radical surgery for Cutaneous Malignant Melanoma (CMM) stage IIb-c and III. * Sufficient renal function for i.v. contrast scannings. Exclusion Criteria: * The patient is assessed as unfit to receive treatment in the case of recurrence. * Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease, terminal multiple sclerosis, liver cirrhosis). * Inability to provide informed consent or refusal to do so. * Inability to comply with the control or intense follow-up program. * Participation in other clinical trials interfering with the control-program. * Existing or previous malignancies within the past 5 years (except for in situ breast and cervical cancer, melanoma in situ and non-melanoma skin cancer). * Pregnancy or currently planned pregnancy.
References
Publications (2)
- DERIVEDLadjevardi CO, Naeser Y, Dyrke U, Papantoniou D, Bagge RO, Elander N, Ingvar C, Flygare P, Nilsson C, Jakobsson F, Lange-Norstrom K, Sundin A, Berglund A, Nyberg F, Ahringberg-Kald B, Helgadottir H, Ullenhag G. Physical examinations and whole-body imaging versus physical examinations alone during follow-up after radical surgery of stage IIB-C and III cutaneous malignant melanoma (TRIM): an interim analysis of a multicentre, randomised, phase 3 trial in Sweden. Lancet Oncol. 2025 Nov;26(11):1501-1510. doi: 10.1016/S1470-2045(25)00487-5. PMID 41167217
- DERIVEDNaeser Y, Helgadottir H, Brandberg Y, Hansson J, Bagge RO, Elander NO, Ingvar C, Isaksson K, Flygare P, Nilsson C, Jakobsson F, Del Val Munoz O, Valachis A, Jansson M, Sparring C, Ohlsson L, Dyrke U, Papantoniou D, Sundin A, Ullenhag GJ. TRIM study protocol - a prospective randomized multicenter Trial to assess the Role of Imaging during follow-up after radical surgery of stage IIB-C and III cutaneous malignant Melanoma. BMC Cancer. 2020 Dec 7;20(1):1197. doi: 10.1186/s12885-020-07632-4. PMID 33287744