A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma

Conditions

Malignant Melanoma

Keywords

Malignant melanoma, Follow up, Radiology, Survival

Brief summary

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.

Detailed description

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.

Ladjevardi CO, Naeser Y, Dyrke U, Papantoniou D, Bagge RO, Elander N, Ingvar C, Flygare P, Nilsson C, Jakobsson F, Lange-Norström K, Sundin A, Berglund A, Nyberg F, Ahringberg-Kald B, Helgadottir H, Ullenhag G.

2025-11-01

10.1016/s1470-2045(25)00487-5

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.

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.

2020-12-0710 citations

10.1186/s12885-020-07632-4

Interventions

PROCEDURECT or PET scans

Scans and blood tests are scheduled at baseline, months 6, 12, 24 and 36.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
Overall survival	At 5 years	Measured from date of inclusion

Secondary

Measure	Time frame	Description
Quality of life/QLQ30	During the 3 year intervention period	Question of Life Questionnaire (QLQ) 30
Quality of life/HAD	During the 3 year intervention period	Hospital, Anxiety and Depression (HAD) scale

Other

Measure	Time frame
Disease free survival (DFS)	3 years

Countries

Sweden

Contacts

Primary ContactGustav J Ullenhag, professor

Gustav.Ullenhag@IGP.uu.se+46186110000

Outcome results

None listed