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

Primary Purpose

Malignant Melanoma

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
CT or PET scans
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malignant Melanoma focused on measuring Malignant melanoma, Follow up, Radiology, Survival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Södra Älvsborgs sjukhusRecruiting
  • Mälarsjukhuset EskilstunaRecruiting
  • Falu lasarettRecruiting
  • Gävle sjukhusRecruiting
  • Department of Surgery, Sahlgrenska University HospitalRecruiting
  • Helsingborgs lasarettRecruiting
  • Länssjukhuset RyhovRecruiting
  • Länssjukhuset i Kalmar
  • Centralsjukhuset i KarlstadRecruiting
  • Linköping University HospitalRecruiting
  • Sunderby sjukhus
  • Skåne University HospitalRecruiting
  • Örebro University HospitalRecruiting
  • Skaraborgs sjukhus SkövdeRecruiting
  • Karolinska University HospitalRecruiting
  • Länssjukhuset SundsvallRecruiting
  • Uddevalla sjukhusRecruiting
  • Umeå University HospitalRecruiting
  • Akademiska sjukhusetRecruiting
  • Västmanlands sjukhus VästeråsRecruiting
  • Visby lasarettRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Routine follow up

Radiological assessments

Arm Description

Follow up according to national guidelines.

Radiological assessments (CT or PET scans) at 5 occasions during 3 years.

Outcomes

Primary Outcome Measures

Overall survival
Measured from date of inclusion

Secondary Outcome Measures

Quality of life/QLQ30
Question of Life Questionnaire (QLQ) 30
Quality of life/HAD
Hospital, Anxiety and Depression (HAD) scale

Full Information

First Posted
March 14, 2017
Last Updated
April 17, 2019
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT03116412
Brief Title
A Randomized Trial to Assess the Role of Imaging During Follow up After Radical Surgery of High Risk Melanoma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
Keywords
Malignant melanoma, Follow up, Radiology, Survival

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine follow up
Arm Type
No Intervention
Arm Description
Follow up according to national guidelines.
Arm Title
Radiological assessments
Arm Type
Experimental
Arm Description
Radiological assessments (CT or PET scans) at 5 occasions during 3 years.
Intervention Type
Procedure
Intervention Name(s)
CT or PET scans
Intervention Description
Scans and blood tests are scheduled at baseline, months 6, 12, 24 and 36.
Primary Outcome Measure Information:
Title
Overall survival
Description
Measured from date of inclusion
Time Frame
At 5 years
Secondary Outcome Measure Information:
Title
Quality of life/QLQ30
Description
Question of Life Questionnaire (QLQ) 30
Time Frame
During the 3 year intervention period
Title
Quality of life/HAD
Description
Hospital, Anxiety and Depression (HAD) scale
Time Frame
During the 3 year intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustav Ullenhag, associate professor
Organizational Affiliation
Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Södra Älvsborgs sjukhus
City
Boras
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janusz Ratajczak, MD
Phone
+46 6161000
Email
janusz.ratajczak@vgregion.se
First Name & Middle Initial & Last Name & Degree
Lars Larsson
Facility Name
Mälarsjukhuset Eskilstuna
City
Eskilstuna
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agneta Nordén
Phone
+4616103343
Email
agneta.norden@dll.se
First Name & Middle Initial & Last Name & Degree
Antonis Valachis
Facility Name
Falu lasarett
City
Falun
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna-Lena Fahlberg
Phone
+46708249653
Email
anna-lena.fahlberg@ltdalarna.se
First Name & Middle Initial & Last Name & Degree
Ulf Dyrke
Facility Name
Gävle sjukhus
City
Gavle
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Persson
Phone
+4626155423
Email
lena.g.persson@regiongavleborg.se
First Name & Middle Initial & Last Name & Degree
Olga val Munos
Facility Name
Department of Surgery, Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Therese Bengtsson
Phone
+46313428454
Email
Therese.Bengtsson@vgregion.se
First Name & Middle Initial & Last Name & Degree
Roger Olofsson Bagge
Facility Name
Helsingborgs lasarett
City
Helsingborg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerstin Reistad
Phone
+46424063762
Email
kerstin.reistad@skane.se
First Name & Middle Initial & Last Name & Degree
Katrin Lange-Norström
Facility Name
Länssjukhuset Ryhov
City
Jonkoping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Therese Karlsson
Phone
+46102425962
Email
therese.i.karlsson@rjl.se
First Name & Middle Initial & Last Name & Degree
Dimitrios Papantoniou
Facility Name
Länssjukhuset i Kalmar
City
Kalmar
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Gustavsson Wallander
Facility Name
Centralsjukhuset i Karlstad
City
Karlstad
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Sätherberg
Phone
+4654615971
Email
eva.satherberg@liv.se
First Name & Middle Initial & Last Name & Degree
Lars Ohlsson
Facility Name
Linköping University Hospital
City
Linkoping
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerstin Hultgren
Phone
+46101031961
Email
kerstin.hultgren@regionostergotland.se
First Name & Middle Initial & Last Name & Degree
Madeleine Rasic
Phone
+46101035879
First Name & Middle Initial & Last Name & Degree
Nils Elander
Facility Name
Sunderby sjukhus
City
Luleå
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Eskilsson
Phone
+46920280063
Email
lisa.eskilsson@norrbotten.se
First Name & Middle Initial & Last Name & Degree
Fredrik Riström
Facility Name
Skåne University Hospital
City
Lund
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gunilla Berggren
Phone
+4646172013
Email
gunilla.GB.berggren@skane.se
First Name & Middle Initial & Last Name & Degree
Karolin Isaksson
Facility Name
Örebro University Hospital
City
Orebro
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Axelsson
Phone
+46196022719
Email
forskningsskoterska.onk.uso@regionorebrolan.se
First Name & Middle Initial & Last Name & Degree
Frida Jakobsson
Facility Name
Skaraborgs sjukhus Skövde
City
Skovde
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Sparring
Phone
+46500432114
Email
charlotte.sparring@vgregion.se
First Name & Middle Initial & Last Name & Degree
Charlotte Sparring
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leia Ollmar
Phone
+46851779694
Email
leia.ollmar@sll.se
First Name & Middle Initial & Last Name & Degree
Johan Hansson
Facility Name
Länssjukhuset Sundsvall
City
Sundsvall
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carina Eliasson
Phone
+46730315197
Email
carina.eliasson@lvn.se
First Name & Middle Initial & Last Name & Degree
Petra Flygare
Facility Name
Uddevalla sjukhus
City
Uddevalla
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annett Gustafsson
Phone
+46104353371
Email
annett.gustafsson@vgregion.se
First Name & Middle Initial & Last Name & Degree
Carin Wångblad
Facility Name
Umeå University Hospital
City
Umea
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agneta Karhu
Phone
+46907850000
Email
agneta.karhu@vll.se
First Name & Middle Initial & Last Name & Degree
Malin Jansson
Facility Name
Akademiska sjukhuset
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Taavo
Phone
+46186111034
Email
camilla.taavo@akademiska.se
First Name & Middle Initial & Last Name & Degree
Gustav Ullenhag
Facility Name
Västmanlands sjukhus Västerås
City
Vasteras
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Hultberg
Phone
+4621173000
Email
liselotte.hultberg@regionvastmanland.se
First Name & Middle Initial & Last Name & Degree
Cecilia Nilsson
Facility Name
Visby lasarett
City
Visby
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Boberg
Phone
+46498269000
Email
marie.boberg01@gotland.se
First Name & Middle Initial & Last Name & Degree
Agneta Nordin Danfors

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33287744
Citation
Naeser Y, Helgadottir H, Brandberg Y, Hansson J, Bagge RO, Elander NO, Ingvar C, Isaksson K, Flygare P, Nilsson C, Jakobsson F, Del Val Munoz O, Valachis A, Jansson M, Sparring C, Ohlsson L, Dyrke U, Papantoniou D, Sundin A, Ullenhag GJ. TRIM study protocol - 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. BMC Cancer. 2020 Dec 7;20(1):1197. doi: 10.1186/s12885-020-07632-4.
Results Reference
derived

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

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