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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.
The patients are randomized 1:1 to routine follow up for 3 years with regular doctors´ appointments according to national guidelines and the same follow up but with the addition of whole body CT or Positron Emission Tomography (PET) scans and blood tests. An interim analysis will be conducted when 1000 patients have been included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine follow up | No Intervention | Follow up according to national guidelines. | |
| Radiological assessments | Experimental | Radiological assessments (CT or PET scans) at 5 occasions during 3 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT or PET scans | Procedure | Scans and blood tests are scheduled at baseline, months 6, 12, 24 and 36. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Measured from date of inclusion | At 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life/QLQ30 | Question of Life Questionnaire (QLQ) 30 | During the 3 year intervention period |
| Quality of life/HAD | Hospital, Anxiety and Depression (HAD) scale |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival (DFS) | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gustav J Ullenhag, professor | Contact | +46186110000 | Gustav.Ullenhag@IGP.uu.se |
| Name | Affiliation | Role |
|---|---|---|
| Gustav Ullenhag, associate professor | Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södra Älvsborgs sjukhus | Terminated | Borås | Sweden | |||
| Mälarsjukhuset Eskilstuna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41167217 | Derived | Ladjevardi 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. | |
| 33287744 |
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| During the 3 year intervention period |
| Recruiting |
| Eskilstuna |
| Sweden |
|
| Falu lasarett | Recruiting | Falun | Sweden |
|
| Gävle sjukhus | Recruiting | Gävle | Sweden |
|
| Department of Surgery, Sahlgrenska University Hospital | Recruiting | Gothenburg | Sweden |
|
| Helsingborgs lasarett | Recruiting | Helsingborg | Sweden |
|
| Länssjukhuset Ryhov | Recruiting | Jönköping | Sweden |
|
| Länssjukhuset i Kalmar | Not yet recruiting | Kalmar | Sweden |
|
| Centralsjukhuset i Karlstad | Recruiting | Karlstad | Sweden |
|
| Linköping University Hospital | Recruiting | Linköping | Sweden |
|
| Skåne University Hospital | Recruiting | Malmö | Sweden |
|
| Örebro University Hospital | Recruiting | Örebro | Sweden |
|
| Skaraborgs sjukhus Skövde | Terminated | Skövde | Sweden |
| Karolinska University Hospital | Recruiting | Stockholm | Sweden |
|
| Länssjukhuset Sundsvall | Recruiting | Sundsvall | Sweden |
|
| Uddevalla sjukhus | Terminated | Uddevalla | Sweden |
| Umeå University Hospital | Terminated | Umeå | Sweden |
| Akademiska sjukhuset | Recruiting | Uppsala | Sweden |
|
| Västmanlands sjukhus Västerås | Recruiting | Västerås | Sweden |
|
| Visby lasarett | Recruiting | Visby | Sweden |
|
| Derived |
| Naeser 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. |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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