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

Last updated: December 11, 2024
Sponsor: Uppsala University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Melanoma

Malignant Melanoma

Treatment

CT or PET scans

Clinical Study ID

NCT03116412
TRIM
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 breastand cervical cancer, melanoma in situ and non-melanoma skin cancer).

  • Pregnancy or currently planned pregnancy.

Study Design

Total Participants: 1300
Treatment Group(s): 1
Primary Treatment: CT or PET scans
Phase:
Study Start date:
June 08, 2017
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Södra Älvsborgs sjukhus

    Boras,
    Sweden

    Terminated

  • Mälarsjukhuset Eskilstuna

    Eskilstuna,
    Sweden

    Active - Recruiting

  • Falu lasarett

    Falun,
    Sweden

    Active - Recruiting

  • Gävle sjukhus

    Gavle,
    Sweden

    Active - Recruiting

  • Department of Surgery, Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Active - Recruiting

  • Helsingborgs lasarett

    Helsingborg,
    Sweden

    Active - Recruiting

  • Länssjukhuset Ryhov

    Jonkoping,
    Sweden

    Active - Recruiting

  • Länssjukhuset i Kalmar

    Kalmar,
    Sweden

    Site Not Available

  • Centralsjukhuset i Karlstad

    Karlstad,
    Sweden

    Active - Recruiting

  • Linköping University Hospital

    Linkoping,
    Sweden

    Active - Recruiting

  • Sunderby sjukhus

    Luleå,
    Sweden

    Site Not Available

  • Sunderby sjukhus

    Luleå-Boden,
    Sweden

    Site Not Available

  • Skåne University Hospital

    Lund,
    Sweden

    Site Not Available

  • Skåne University Hospital

    Lund-Malmö,
    Sweden

    Site Not Available

  • Skåne University Hospital

    Malmö,
    Sweden

    Active - Recruiting

  • Örebro University Hospital

    Orebro,
    Sweden

    Active - Recruiting

  • Skaraborgs sjukhus Skövde

    Skovde,
    Sweden

    Terminated

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Active - Recruiting

  • Länssjukhuset Sundsvall

    Sundsvall,
    Sweden

    Active - Recruiting

  • Uddevalla sjukhus

    Uddevalla,
    Sweden

    Terminated

  • Umeå University Hospital

    Umea,
    Sweden

    Terminated

  • Akademiska sjukhuset

    Uppsala,
    Sweden

    Active - Recruiting

  • Västmanlands sjukhus Västerås

    Vasteras,
    Sweden

    Active - Recruiting

  • Visby lasarett

    Visby,
    Sweden

    Active - Recruiting

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