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

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ClinicalTrials.gov Identifier: NCT03116412
Recruitment Status : Recruiting
First Posted : April 17, 2017
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Procedure: CT or PET scans Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : June 8, 2017
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: At 5 years ]
    Measured from date of inclusion


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116412


Locations
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Sweden
Södra Älvsborgs sjukhus Recruiting
Boras, Sweden
Contact: Janusz Ratajczak, MD    +46 6161000    janusz.ratajczak@vgregion.se   
Principal Investigator: Lars Larsson         
Mälarsjukhuset Eskilstuna Recruiting
Eskilstuna, Sweden
Contact: Agneta Nordén    +4616103343    agneta.norden@dll.se   
Principal Investigator: Antonis Valachis         
Falu lasarett Recruiting
Falun, Sweden
Contact: Anna-Lena Fahlberg    +46708249653    anna-lena.fahlberg@ltdalarna.se   
Principal Investigator: Ulf Dyrke         
Gävle sjukhus Recruiting
Gavle, Sweden
Contact: Lena Persson    +4626155423    lena.g.persson@regiongavleborg.se   
Principal Investigator: Olga val Munos         
Department of Surgery, Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Therese Bengtsson    +46313428454    Therese.Bengtsson@vgregion.se   
Principal Investigator: Roger Olofsson Bagge         
Helsingborgs lasarett Recruiting
Helsingborg, Sweden
Contact: Kerstin Reistad    +46424063762    kerstin.reistad@skane.se   
Principal Investigator: Katrin Lange-Norström         
Länssjukhuset Ryhov Recruiting
Jonkoping, Sweden
Contact: Therese Karlsson    +46102425962    therese.i.karlsson@rjl.se   
Principal Investigator: Dimitrios Papantoniou         
Länssjukhuset i Kalmar Not yet recruiting
Kalmar, Sweden
Principal Investigator: Lars Gustavsson Wallander         
Centralsjukhuset i Karlstad Recruiting
Karlstad, Sweden
Contact: Eva Sätherberg    +4654615971    eva.satherberg@liv.se   
Principal Investigator: Lars Ohlsson         
Linköping University Hospital Recruiting
Linkoping, Sweden
Contact: Kerstin Hultgren    +46101031961    kerstin.hultgren@regionostergotland.se   
Contact: Madeleine Rasic    +46101035879      
Principal Investigator: Nils Elander         
Sunderby sjukhus Not yet recruiting
Luleå, Sweden
Contact: Lisa Eskilsson    +46920280063    lisa.eskilsson@norrbotten.se   
Principal Investigator: Fredrik Riström         
Skåne University Hospital Recruiting
Lund, Sweden
Contact: Gunilla Berggren    +4646172013    gunilla.GB.berggren@skane.se   
Principal Investigator: Karolin Isaksson         
Örebro University Hospital Recruiting
Orebro, Sweden
Contact: Sofia Axelsson    +46196022719    forskningsskoterska.onk.uso@regionorebrolan.se   
Principal Investigator: Frida Jakobsson         
Skaraborgs sjukhus Skövde Recruiting
Skovde, Sweden
Contact: Charlotte Sparring    +46500432114    charlotte.sparring@vgregion.se   
Principal Investigator: Charlotte Sparring         
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Leia Ollmar    +46851779694    leia.ollmar@sll.se   
Principal Investigator: Johan Hansson         
Länssjukhuset Sundsvall Recruiting
Sundsvall, Sweden
Contact: Carina Eliasson    +46730315197    carina.eliasson@lvn.se   
Principal Investigator: Petra Flygare         
Uddevalla sjukhus Recruiting
Uddevalla, Sweden
Contact: Annett Gustafsson    +46104353371    annett.gustafsson@vgregion.se   
Principal Investigator: Carin Wångblad         
Umeå University Hospital Recruiting
Umea, Sweden
Contact: Agneta Karhu    +46907850000    agneta.karhu@vll.se   
Principal Investigator: Malin Jansson         
Akademiska sjukhuset Recruiting
Uppsala, Sweden
Contact: Camilla Taavo    +46186111034    camilla.taavo@akademiska.se   
Principal Investigator: Gustav Ullenhag         
Västmanlands sjukhus Västerås Recruiting
Vasteras, Sweden
Contact: Lisa Hultberg    +4621173000    liselotte.hultberg@regionvastmanland.se   
Principal Investigator: Cecilia Nilsson         
Visby lasarett Recruiting
Visby, Sweden
Contact: Marie Boberg    +46498269000    marie.boberg01@gotland.se   
Principal Investigator: Agneta Nordin Danfors         
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Gustav Ullenhag, associate professor Uppsala University Hospital

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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03116412     History of Changes
Other Study ID Numbers: TRIM
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Uppsala University:
Malignant melanoma
Follow up
Radiology
Survival

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas