Malignant MelanomaTRIMNCT03116412
A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma
A study testing CT or PET scans in people with Malignant Melanoma, run by Uppsala University at 20 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- CT or PET scans
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 20 sitesSweden
- Study dates
- 8 Jun 2017to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
Sweden20 sites, 16 recruiting
- Terminated
Södra Älvsborgs sjukhus
Borås
- Recruiting
Mälarsjukhuset Eskilstuna
Eskilstuna
Pia Polhage Enerbranth, +4616103972, Pia.PolhageEnerbranth@dll.se
Andreas Nearchou
- Recruiting
Falu lasarett
Falun
Ulf Dyrke, +46708249653, Ulf.Dyrke@Regiondalarna.se
Ulf Dyrke
- Recruiting
Gävle sjukhus
Gävle
Ulrika Åsenlund, +4626155423, Ulrika.Asenlund@regiongavleborg.se
Olga val Munos
- Recruiting
Department of Surgery, Sahlgrenska University Hospital
Gothenburg
Désirée Bourghardt Wiklund, +46313421119, Desiree.Bourghardt.Wiklund@vgregion.se
Roger Olofsson Bagge
- Recruiting
Helsingborgs lasarett
Helsingborg
Kerstin Reistad, +46424063762, kerstin.reistad@skane.se
Linnea Huss
- Recruiting
Länssjukhuset Ryhov
Jönköping
Therese Karlsson, +46102425962, therese.i.karlsson@rjl.se
Dimitrios Papantoniou
- Not yet recruiting
Länssjukhuset i Kalmar
Kalmar
Helen Jung, +46480448656, Helen.Jung@Regionkalmar.se
Magnus Lagerlund
- Recruiting
Centralsjukhuset i Karlstad
Karlstad
Sandra Hvitt, +4654615971, Sandra.Hvitt@Regionvarmland.se
Kristin Larsson
- Recruiting
Linköping University Hospital
Linköping
Kerstin Hultgren, +46101031961, kerstin.hultgren@regionostergotland.se
Madeleine Rasic, +46101035879
- Recruiting
Skåne University Hospital
Malmö
Gunilla Berggren, +4646172013, gunilla.GB.berggren@skane.se
Bengt Ahringberg
- Recruiting
Örebro University Hospital
Örebro
Ylva Storck, +46196022719, forskningsskoterska.onk.uso@regionorebrolan.se
Frida Jakobsson
- Terminated
Skaraborgs sjukhus Skövde
Skövde
- Recruiting
Karolinska University Hospital
Stockholm
Amanda Hallgren, +46812371791, Amanda.Hallgren@RegionStockholm.se
Hildur Helgadottir
- Recruiting
Länssjukhuset Sundsvall
Sundsvall
Carina Eliasson, +46730315197, carina.eliasson@lvn.se
Petra Flygare
- Terminated
Uddevalla sjukhus
Uddevalla
- Terminated
Umeå University Hospital
Umeå
- Recruiting
Akademiska sjukhuset
Uppsala
Camilla Taavo, +46186111034, camilla.taavo@akademiska.se
Gustav Ullenhag
- Recruiting
Västmanlands sjukhus Västerås
Västerås
Susanne Widegren, +4621173000, Susanne.Widegren@regionvastmanland.se
Cecilia Nilsson
- Recruiting
Visby lasarett
Visby
Marie Boberg, +46498269000, marie.boberg01@gotland.se
Agneta Nordin Danfors
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Malignant Melanoma
- Being tested
- CT or PET scans
- Keywords
- Malignant melanoma, Follow up, Radiology, Survival
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT or PET scansProcedure or surgery
Scans and blood tests are scheduled at baseline, months 6, 12, 24 and 36.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: CT or PET scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured from date of inclusion
Measured: At 5 years
Secondary outcomes (2)
Quality of life/QLQ30
Question of Life Questionnaire (QLQ) 30
Measured: During the 3 year intervention period
Quality of life/HAD
Hospital, Anxiety and Depression (HAD) scale
Measured: During the 3 year intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start8 Jun 2017
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gustav Ullenhag, associate professor, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116412
- Sponsor's protocol ID
- TRIM
- Acronym
- TRIM
- Status last verified
- Dec 2024
- First submitted
- 14 Mar 2017
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41167217Naeser 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.
PubMed 33287744
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03116412
- Acronym / sponsor ID
- TRIM / TRIM
- Conditions
- Malignant Melanoma
- Keywords
- Malignant melanoma, Follow up, Radiology, Survival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine follow up | No intervention | –Follow up according to national guidelines. |
| Radiological assessments | Experimental | Procedure: CT or PET scansRadiological assessments (CT or PET scans) at 5 occasions during 3 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT or PET scansScans and blood tests are scheduled at baseline, months 6, 12, 24 and 36. | Procedure or surgery | Radiological assessments |
Primary outcome
Overall survival
Time frame: At 5 years
Measured from date of inclusion
2 secondary outcomes
Quality of life/QLQ30
Time frame: During the 3 year intervention period
Quality of life/HAD
Time frame: During the 3 year intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 41167217Ladjevardi 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.
- Derived from this study: PubMed 33287744Naeser 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gustav Ullenhag, associate professor principal investigator
Uppsala University Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT or PET scans in people with Malignant Melanoma, run by Uppsala University at 20 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gustav J Ullenhag, professor (+46186110000, Gustav.Ullenhag@IGP.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: At 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03116412, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.