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

Malignant Melanoma Clinical Trial

— TRIM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03116412
• Other study ID #: TRIM
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2017
• Est. completion date: December 31, 2028

Study information

• Verified date: May 2024
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. With the introduction of effective medical treatments for malignant melanoma patients, there is a tendency to introduce radiological assessments despite the lack of evidence.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Procedure:
• CT or PET scans
Scans and blood tests are scheduled at baseline, months 6, 12, 24 and 36.

Locations

Country	Name	City	State
Sweden	Södra Älvsborgs sjukhus	Boras
Sweden	Mälarsjukhuset Eskilstuna	Eskilstuna
Sweden	Falu lasarett	Falun
Sweden	Gävle sjukhus	Gavle
Sweden	Department of Surgery, Sahlgrenska University Hospital	Gothenburg
Sweden	Helsingborgs lasarett	Helsingborg
Sweden	Länssjukhuset Ryhov	Jonkoping
Sweden	Länssjukhuset i Kalmar	Kalmar
Sweden	Centralsjukhuset i Karlstad	Karlstad
Sweden	Linköping University Hospital	Linkoping
Sweden	Skåne University Hospital	Malmö
Sweden	Örebro University Hospital	Orebro
Sweden	Skaraborgs sjukhus Skövde	Skovde
Sweden	Karolinska University Hospital	Stockholm
Sweden	Länssjukhuset Sundsvall	Sundsvall
Sweden	Uddevalla sjukhus	Uddevalla
Sweden	Umeå University Hospital	Umea
Sweden	Akademiska sjukhuset	Uppsala
Sweden	Västmanlands sjukhus Västerås	Vasteras
Sweden	Visby lasarett	Visby

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Measured from date of inclusion	At 5 years
Secondary	Quality of life/QLQ30	Question of Life Questionnaire (QLQ) 30	During the 3 year intervention period
Secondary	Quality of life/HAD	Hospital, Anxiety and Depression (HAD) scale	During the 3 year intervention period