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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03116412
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Uppsala University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gustav Ullenhag, associate professor
Principal Investigator Affiliation Uppsala University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Sweden
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Melanoma
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

Procedure: - CT or PET scans

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Södra Älvsborgs sjukhus, Boras, Sweden

Status

Recruiting

Address

Södra Älvsborgs sjukhus

Boras, ,

Site Contact

Janusz Ratajczak, MD

[email protected]

+46 6161000

Mälarsjukhuset Eskilstuna, Eskilstuna, Sweden

Status

Recruiting

Address

Mälarsjukhuset Eskilstuna

Eskilstuna, ,

Site Contact

Pia Polhage Enerbranth

[email protected]

+4616103972

Falu lasarett, Falun, Sweden

Status

Recruiting

Address

Falu lasarett

Falun, ,

Site Contact

Ulf Dyrke

[email protected]

+46708249653

Gävle sjukhus, Gavle, Sweden

Status

Recruiting

Address

Gävle sjukhus

Gavle, ,

Site Contact

Ulrika Åsenlund

[email protected]

+4626155423

Gothenburg, Sweden

Status

Recruiting

Address

Department of Surgery, Sahlgrenska University Hospital

Gothenburg, ,

Site Contact

Désirée Bourghardt Wiklund

[email protected]

+46313421119

Helsingborgs lasarett, Helsingborg, Sweden

Status

Recruiting

Address

Helsingborgs lasarett

Helsingborg, ,

Site Contact

Kerstin Reistad

[email protected]

+46424063762

Länssjukhuset Ryhov, Jonkoping, Sweden

Status

Recruiting

Address

Länssjukhuset Ryhov

Jonkoping, ,

Site Contact

Therese Karlsson

[email protected]

+46102425962

Länssjukhuset i Kalmar, Kalmar, Sweden

Status

Not yet recruiting

Address

Länssjukhuset i Kalmar

Kalmar, ,

Site Contact

Helen Jung

[email protected]

+46480448656

Centralsjukhuset i Karlstad, Karlstad, Sweden

Status

Recruiting

Address

Centralsjukhuset i Karlstad

Karlstad, ,

Site Contact

Sandra Hvitt

[email protected]

+4654615971

Linköping University Hospital, Linkoping, Sweden

Status

Recruiting

Address

Linköping University Hospital

Linkoping, ,

Site Contact

Kerstin Hultgren

[email protected]

+46101031961

Skåne University Hospital, Malmö, Sweden

Status

Recruiting

Address

Skåne University Hospital

Malmö, ,

Site Contact

Gunilla Berggren

[email protected]

+4646172013

Örebro University Hospital, Orebro, Sweden

Status

Recruiting

Address

Örebro University Hospital

Orebro, ,

Site Contact

Ylva Storck

[email protected]

+46196022719

Skaraborgs sjukhus Skövde, Skovde, Sweden

Status

Recruiting

Address

Skaraborgs sjukhus Skövde

Skovde, ,

Site Contact

Åsa Nilsson

[email protected]

+46500432114

Karolinska University Hospital, Stockholm, Sweden

Status

Recruiting

Address

Karolinska University Hospital

Stockholm, ,

Site Contact

Amanda Hallgren

[email protected]

+46812371791

Länssjukhuset Sundsvall, Sundsvall, Sweden

Status

Recruiting

Address

Länssjukhuset Sundsvall

Sundsvall, ,

Site Contact

Carina Eliasson

[email protected]

+46730315197

Uddevalla sjukhus, Uddevalla, Sweden

Status

Recruiting

Address

Uddevalla sjukhus

Uddevalla, ,

Site Contact

Annett Gustafsson

[email protected]

+46104353371

Umeå University Hospital, Umea, Sweden

Status

Recruiting

Address

Umeå University Hospital

Umea, ,

Site Contact

Agneta Karhu

[email protected]

+46907850000

Akademiska sjukhuset, Uppsala, Sweden

Status

Recruiting

Address

Akademiska sjukhuset

Uppsala, ,

Site Contact

Camilla Taavo

[email protected]

+46186111034

Västmanlands sjukhus Västerås, Vasteras, Sweden

Status

Recruiting

Address

Västmanlands sjukhus Västerås

Vasteras, ,

Site Contact

Susanne Widegren

[email protected]

+4621173000

Visby lasarett, Visby, Sweden

Status

Recruiting

Address

Visby lasarett

Visby, ,

Site Contact

Marie Boberg

[email protected]

+46498269000

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