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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-08

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Malignant Melanoma

Keywords

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Malignant melanoma Follow up Radiology Survival

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Routine follow up

Follow up according to national guidelines.

Group Type NO_INTERVENTION

No interventions assigned to this group

Radiological assessments

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

Group Type EXPERIMENTAL

CT or PET scans

Intervention Type PROCEDURE

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

Interventions

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CT or PET scans

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gustav Ullenhag, associate professor

Role: PRINCIPAL_INVESTIGATOR

Uppsala University Hospital

Visby, , Sweden

Site Status RECRUITING

Countries

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Role: backup

References

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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.

Reference Type DERIVED

PMID: 33287744 (View on PubMed)

Other Identifiers

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TRIM

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Routine follow up

Radiological assessments

CT or PET scans

Interventions

CT or PET scans

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Uppsala University

Responsible Party

Principal Investigators

Gustav Ullenhag, associate professor

Locations

Södra Älvsborgs sjukhus

Mälarsjukhuset Eskilstuna

Falu lasarett

Gävle sjukhus

Department of Surgery, Sahlgrenska University Hospital

Helsingborgs lasarett

Länssjukhuset Ryhov

Länssjukhuset i Kalmar

Centralsjukhuset i Karlstad

Linköping University Hospital

Skåne University Hospital

Örebro University Hospital

Skaraborgs sjukhus Skövde

Karolinska University Hospital

Länssjukhuset Sundsvall

Uddevalla sjukhus

Umeå University Hospital

Akademiska sjukhuset

Västmanlands sjukhus Västerås

Visby lasarett

Countries

Central Contacts

Gustav J Ullenhag, professor

Facility Contacts

Pia Polhage Enerbranth

Andreas Nearchou

Ulf Dyrke

Ulf Dyrke

Ulrika Åsenlund

Olga val Munos

Désirée Bourghardt Wiklund

Roger Olofsson Bagge

Kerstin Reistad

Linnea Huss

Therese Karlsson

Dimitrios Papantoniou

Helen Jung

Magnus Lagerlund

Sandra Hvitt

Kristin Larsson

Kerstin Hultgren

Madeleine Rasic

Sander Ellergåd

Gunilla Berggren

Bengt Ahringberg

Ylva Storck

Frida Jakobsson

Amanda Hallgren

Hildur Helgadottir

Carina Eliasson

Petra Flygare

Camilla Taavo

Gustav Ullenhag

Susanne Widegren

Cecilia Nilsson

Marie Boberg

Agneta Nordin Danfors