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. An interim analysis will be conducted when 1000 patients have been included.

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, Borås 2720501, Sweden

Status

Terminated

Address

Södra Älvsborgs sjukhus

Borås 2720501, ,

Mälarsjukhuset Eskilstuna, Eskilstuna 2715953, Sweden

Status

Recruiting

Address

Mälarsjukhuset Eskilstuna

Eskilstuna 2715953, ,

Site Contact

Pia Polhage Enerbranth

[email protected]

+4616103972

Falu lasarett, Falun 2715459, Sweden

Status

Recruiting

Address

Falu lasarett

Falun 2715459, ,

Site Contact

Ulf Dyrke

[email protected]

+46708249653

Gävle sjukhus, Gävle 2712414, Sweden

Status

Recruiting

Address

Gävle sjukhus

Gävle 2712414, ,

Site Contact

Ulrika Åsenlund

[email protected]

+4626155423

Gothenburg 2711537, Sweden

Status

Recruiting

Address

Department of Surgery, Sahlgrenska University Hospital

Gothenburg 2711537, ,

Site Contact

Désirée Bourghardt Wiklund

[email protected]

+46313421119

Helsingborgs lasarett, Helsingborg 2706767, Sweden

Status

Recruiting

Address

Helsingborgs lasarett

Helsingborg 2706767, ,

Site Contact

Kerstin Reistad

[email protected]

+46424063762

Länssjukhuset Ryhov, Jönköping 2702979, Sweden

Status

Recruiting

Address

Länssjukhuset Ryhov

Jönköping 2702979, ,

Site Contact

Therese Karlsson

[email protected]

+46102425962

Länssjukhuset i Kalmar, Kalmar 2702261, Sweden

Status

Not yet recruiting

Address

Länssjukhuset i Kalmar

Kalmar 2702261, ,

Site Contact

Helen Jung

[email protected]

+46480448656

Centralsjukhuset i Karlstad, Karlstad 2701680, Sweden

Status

Recruiting

Address

Centralsjukhuset i Karlstad

Karlstad 2701680, ,

Site Contact

Sandra Hvitt

[email protected]

+4654615971

Linköping University Hospital, Linköping 2694762, Sweden

Status

Recruiting

Address

Linköping University Hospital

Linköping 2694762, ,

Site Contact

Kerstin Hultgren

[email protected]

+46101031961

Skåne University Hospital, Malmo 2692969, Sweden

Status

Recruiting

Address

Skåne University Hospital

Malmo 2692969, ,

Site Contact

Gunilla Berggren

[email protected]

+4646172013

Örebro University Hospital, Örebro 2686657, Sweden

Status

Recruiting

Address

Örebro University Hospital

Örebro 2686657, ,

Site Contact

Ylva Storck

[email protected]

+46196022719

Skaraborgs sjukhus Skövde, Skövde 2677234, Sweden

Status

Terminated

Address

Skaraborgs sjukhus Skövde

Skövde 2677234, ,

Karolinska University Hospital, Stockholm 2673730, Sweden

Status

Recruiting

Address

Karolinska University Hospital

Stockholm 2673730, ,

Site Contact

Amanda Hallgren

[email protected]

+46812371791

Länssjukhuset Sundsvall, Sundsvall 2670781, Sweden

Status

Recruiting

Address

Länssjukhuset Sundsvall

Sundsvall 2670781, ,

Site Contact

Carina Eliasson

[email protected]

+46730315197

Uddevalla sjukhus, Uddevalla 2666670, Sweden

Status

Terminated

Address

Uddevalla sjukhus

Uddevalla 2666670, ,

Umeå University Hospital, Umeå 602150, Sweden

Status

Terminated

Address

Umeå University Hospital

Umeå 602150, ,

Akademiska sjukhuset, Uppsala 2666199, Sweden

Status

Recruiting

Address

Akademiska sjukhuset

Uppsala 2666199, ,

Site Contact

Camilla Taavo

[email protected]

+46186111034

Västmanlands sjukhus Västerås, Västerås 2664454, Sweden

Status

Recruiting

Address

Västmanlands sjukhus Västerås

Västerås 2664454, ,

Site Contact

Susanne Widegren

[email protected]

+4621173000

Visby lasarett, Visby 2662689, Sweden

Status

Recruiting

Address

Visby lasarett

Visby 2662689, ,

Site Contact

Marie Boberg

[email protected]

+46498269000

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