NCT03116412 A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma
| NCT ID | NCT03116412 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University |
| Condition | Malignant Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,300 participants |
| Start Date | 2017-06-08 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,300 participants in total. It began in 2017-06-08 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Gustav Ullenhag, associate professor
PRINCIPAL INVESTIGATOR
Uppsala University Hospital
Frequently Asked Questions
Who can join the NCT03116412 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03116412 currently recruiting?
Yes, NCT03116412 is actively recruiting participants. Contact the research team at Gustav.Ullenhag@IGP.uu.se for enrollment information.
Where is the NCT03116412 trial being conducted?
This trial is being conducted at Borås, Sweden, Eskilstuna, Sweden, Falun, Sweden, Gävle, Sweden and 11 additional locations.
Who is sponsoring the NCT03116412 clinical trial?
NCT03116412 is sponsored by Uppsala University. The principal investigator is Gustav Ullenhag, associate professor at Uppsala University Hospital. The trial plans to enroll 1,300 participants.
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