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

April 17, 2019 updated by: Uppsala University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Boras, Sweden
        • Recruiting
        • Södra Älvsborgs Sjukhus
        • Contact:
        • Principal Investigator:
          • Lars Larsson
      • Eskilstuna, Sweden
        • Recruiting
        • Mälarsjukhuset Eskilstuna
        • Principal Investigator:
          • Antonis Valachis
        • Contact:
      • Falun, Sweden
      • Gavle, Sweden
      • Gothenburg, Sweden
        • Recruiting
        • Department of surgery, Sahlgrenska University Hospital
        • Contact:
        • Principal Investigator:
          • Roger Olofsson Bagge
      • Helsingborg, Sweden
        • Recruiting
        • Helsingborgs lasarett
        • Contact:
        • Principal Investigator:
          • Katrin Lange-Norström
      • Jonkoping, Sweden
        • Recruiting
        • Länssjukhuset Ryhov
        • Contact:
        • Principal Investigator:
          • Dimitrios Papantoniou
      • Kalmar, Sweden
        • Not yet recruiting
        • Länssjukhuset i Kalmar
        • Principal Investigator:
          • Lars Gustavsson Wallander
      • Karlstad, Sweden
        • Recruiting
        • Centralsjukhuset i Karlstad
        • Contact:
        • Principal Investigator:
          • Lars Ohlsson
      • Linkoping, Sweden
        • Recruiting
        • Linkoping University Hospital
        • Contact:
        • Contact:
          • Madeleine Rasic
          • Phone Number: +46101035879
        • Principal Investigator:
          • Nils Elander
      • Luleå, Sweden
        • Not yet recruiting
        • Sunderby Sjukhus
        • Contact:
        • Principal Investigator:
          • Fredrik Riström
      • Lund, Sweden
        • Recruiting
        • Skane University Hospital
        • Contact:
        • Principal Investigator:
          • Karolin Isaksson
      • Orebro, Sweden
      • Skovde, Sweden
        • Recruiting
        • Skaraborgs sjukhus Skövde
        • Contact:
        • Principal Investigator:
          • Charlotte Sparring
      • Stockholm, Sweden
        • Recruiting
        • Karolinska University Hospital
        • Contact:
        • Principal Investigator:
          • Johan Hansson
      • Sundsvall, Sweden
        • Recruiting
        • Länssjukhuset Sundsvall
        • Contact:
        • Principal Investigator:
          • Petra Flygare
      • Uddevalla, Sweden
        • Recruiting
        • Uddevalla Sjukhus
        • Contact:
        • Principal Investigator:
          • Carin Wångblad
      • Umea, Sweden
        • Recruiting
        • Umeå University Hospital
        • Contact:
        • Principal Investigator:
          • Malin Jansson
      • Uppsala, Sweden
        • Recruiting
        • Akademiska Sjukhuset
        • Contact:
        • Principal Investigator:
          • Gustav Ullenhag
      • Vasteras, Sweden
      • Visby, Sweden
        • Recruiting
        • Visby lasarett
        • Contact:
        • Principal Investigator:
          • Agneta Nordin Danfors

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine follow up
Follow up according to national guidelines.
Experimental: Radiological assessments
Radiological assessments (CT or PET scans) at 5 occasions during 3 years.
Procedure: CT or PET scans
Scans and blood tests are scheduled at baseline, months 6, 12, 24 and 36.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: At 5 years
Measured from date of inclusion
At 5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Gustav Ullenhag, associate professor, Uppsala University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2017

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

April 11, 2017

First Posted (Actual)

April 17, 2017

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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