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NCT Number: NCT03116412

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

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Södra Älvsborgs sjukhus, Borås, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CT or PET scans

Procedure

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

Primary outcomes

  1. Overall survival

    Time frame: At 5 years

    Measured from date of inclusion

Secondary outcomes

  1. Quality of life/QLQ30

    Time frame: During the 3 year intervention period

    Question of Life Questionnaire (QLQ) 30

  2. Quality of life/HAD

    Time frame: During the 3 year intervention period

    Hospital, Anxiety and Depression (HAD) scale

Other outcomes

  1. Disease free survival (DFS)

    Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Gustav J Ullenhag, professor

CONTACT

[email protected]

+46186110000

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study 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

Acronym: TRIM

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Apr 17, 2017
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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