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Clinical Trials in Sweden / NCT03116412
Recruiting Not applicable

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

NCT03116412 · tracked via the Priya Life Science Sweden tracker
Sponsor
Uppsala University
Phase
Not applicable
Started
2017-06-08
Last updated
2024-12-16

Condition(s) studied

Malignant Melanoma

Investigational drug(s) / intervention(s)

CT or PET scans

CT or PET scans: Scans and blood tests are scheduled at baseline, months 6, 12, 24 and 36.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Overall survival — At 5 years
    Measured from date of inclusion

Trial sites (20)

FacilityCityRegionStatus
Södra Älvsborgs sjukhus Borås Sweden Terminated
Mälarsjukhuset Eskilstuna Eskilstuna Sweden Recruiting
Falu lasarett Falun Sweden Recruiting
Gävle sjukhus Gävle Sweden Recruiting
Department of Surgery, Sahlgrenska University Hospital Gothenburg Sweden Recruiting
Helsingborgs lasarett Helsingborg Sweden Recruiting
Länssjukhuset Ryhov Jönköping Sweden Recruiting
Länssjukhuset i Kalmar Kalmar Sweden Not Yet Recruiting
Centralsjukhuset i Karlstad Karlstad Sweden Recruiting
Linköping University Hospital Linköping Sweden Recruiting
Skåne University Hospital Malmö Sweden Recruiting
Örebro University Hospital Örebro Sweden Recruiting
Skaraborgs sjukhus Skövde Skövde Sweden Terminated
Karolinska University Hospital Stockholm Sweden Recruiting
Länssjukhuset Sundsvall Sundsvall Sweden Recruiting
Uddevalla sjukhus Uddevalla Sweden Terminated
Umeå University Hospital Umeå Sweden Terminated
Akademiska sjukhuset Uppsala Sweden Recruiting
Västmanlands sjukhus Västerås Västerås Sweden Recruiting
Visby lasarett Visby Sweden Recruiting

More Uppsala University trials in Sweden

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Robotic-Assisted Pedicle Screw Placement in Spine Surgery Recruiting
The Scandinavian Displaced Lateral Clavicle Trial Recruiting
Fusion or Not - a Study on Low Back Pain Recruiting
Nutrition and Inflammation in Patients With Head and Neck Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03116412 on ClinicalTrials.gov ↗ ← All trials in Sweden