MelanomaNCT01677975
The Value of Preoperative Dynamic Lymphscintigraphy and Ultrasoundscanning, Eventually With FNA, for Identification of Malignant Sentinel Node(s) in Patients With Melanoma
A study testing FNA (fine needle aspiration) in people with Melanoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The goal with this study is to evaluate the value of dynamic lymphscintigraphy and ultrasoundscanning preoperative in patients with melanomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- FNA (fine needle aspiration)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified melanomas, at least 1 mm thickness, or thinner melanomas with ulceration and/or Clarks level IV-V and/or mitoserate at least 1/mm2.
Who cannot join
- Other malignant illness Known local, regional or non-regional metastasis on the time of diagnonsis Comorbidity which contraindicate lymphnoderemoval Age less than 18 yrs
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Ultrasounddepartment 4123, Rigshospitalet
Blegdamsvej 9, København Ø, 2100
About this study
The goal with this study is to evaluate the value of dynamic lymphscintigraphy and ultrasoundscanning preoperative in patients with melanomas.
- Conditions
- Melanoma
- Being tested
- FNA (fine needle aspiration)
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FNA (fine needle aspiration)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ultrasound, dynamic lymphscintigraphy | Experimental | Not described Receives: Procedure: FNA (fine needle aspiration) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trine-Lise Lambine, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677975
- Sponsor's protocol ID
- Ultrasound in melanomas
- Status last verified
- Aug 2012
- First submitted
- 30 Aug 2012
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Preoperative Dynamic Lymphscintigraphy and Ultrasoundscanning, Eventually With FNA, for Identification of Malignant Sentinel Node(s) in Patients With Melanoma
- ClinicalTrials.gov ID
- NCT01677975
- Acronym / sponsor ID
- Ultrasound in melanomas
- Conditions
- Melanoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Sep 2012
- First posted
- 3 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal with this study is to evaluate the value of dynamic lymphscintigraphy and ultrasoundscanning preoperative in patients with melanomas.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound, dynamic lymphscintigraphy | Experimental | Procedure: FNA (fine needle aspiration) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically verified melanomas, at least 1 mm thickness, or thinner melanomas with ulceration and/or Clarks level IV-V and/or mitoserate at least 1/mm2.
Key exclusion criteria (1 listed)
- Other malignant illness Known local, regional or non-regional metastasis on the time of diagnonsis Comorbidity which contraindicate lymphnoderemoval Age less than 18 yrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FNA (fine needle aspiration) | Procedure or surgery | ultrasound, dynamic lymphscintigraphy |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FNA (fine needle aspiration) in people with Melanoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2012.