MelanomaNCT05817149
Perioperative Examination of Inflammatory Markers in Relation to Sentinel Lymph Node Biopsy in Patients With Melanoma; a Pilot Study
An observational study of Melanoma and Surgery, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
We want to test if an association between sentinel lymph node biopsy (SLBN) and a systemic inflammatory response can be made. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Blood samples
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Jun 2021to 20 Jan 2022
- Phase
- Observational
- 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
Study population: Patients (n=20) diagnosed with malignant melanoma and scheduled for SLNB at Aalborg University Hospital were consecutively included from June 2021 to October 2021.
Who may be able to join
- Adult (>18 years of age)
- Diagnosed with invasive cutaneous melanoma
- Eligible for SLNB (Melanoma stage ≥ T1b)
- Obtained signed informed consent
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aalborg University Hospital
Aalborg, The North Denmark Region, 9000
About this study
We want to test if an association between sentinel lymph node biopsy (SLBN) and a systemic inflammatory response can be made.
Read the detailed description
Sentinel lymph node biopsy (SLBN) is essential in staging melanoma and properly selecting patients for adjuvant immunotherapy. However, surgically induced inflammation can potentially aid in progression of remaining malignant cells and affect prognosis. The inflammatory marker neutrophil-to-lymphocyte ratio (NLR) is also a negative prognostic and predictive marker in serval malignancies, among melanoma. However, it is not yet established if SLNB induces a systemic inflammatory response.
- Being tested
- Blood samples
- Keywords
- Melanoma, Surgery, Neutrophil-to-lymphocyte ratio, Surgical inflammation
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesProcedure or surgery
Blood samples
| Study group | Role | What they receive |
|---|---|---|
| Patients with melanoma | Patients with melanoma undergoing sentinel lymph node biopsy with perioperative blood samples. Receives: Procedure: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil-to-lymphocyte ratio
Ratio between neutrophil granulocytes and lymphocytes
Measured: 1 Day
Secondary outcomes (2)
Pro-inflammatory cytokines
IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNF-α, and IFN-γ
Measured: 1 Day
Acute phase reactants
CRP, LDH
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start22 Jun 2021
- Primary completion6 Oct 2021
- Study completion20 Jan 2022
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 Aalborg University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Karoline Assifuah Kristjansen, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817149
- Sponsor's protocol ID
- 2021-050
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Examination of Inflammatory Markers in Relation to Sentinel Lymph Node Biopsy in Patients With Melanoma; a Pilot Study
- ClinicalTrials.gov ID
- NCT05817149
- Acronym / sponsor ID
- 2021-050
- Keywords
- Melanoma, Surgery, Neutrophil-to-lymphocyte ratio, Surgical inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 18 Apr 2023 (actual)
- 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.
We want to test if an association between sentinel lymph node biopsy (SLBN) and a systemic inflammatory response can be made.
Detailed description
Sentinel lymph node biopsy (SLBN) is essential in staging melanoma and properly selecting patients for adjuvant immunotherapy. However, surgically induced inflammation can potentially aid in progression of remaining malignant cells and affect prognosis. The inflammatory marker neutrophil-to-lymphocyte ratio (NLR) is also a negative prognostic and predictive marker in serval malignancies, among melanoma. However, it is not yet established if SLNB induces a systemic inflammatory response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with melanoma | – | Procedure: Blood samplesPatients with melanoma undergoing sentinel lymph node biopsy with perioperative blood samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (n=20) diagnosed with malignant melanoma and scheduled for SLNB at Aalborg University Hospital were consecutively included from June 2021 to October 2021.
Key inclusion criteria (4 listed)
- Adult (>18 years of age)
- Diagnosed with invasive cutaneous melanoma
- Eligible for SLNB (Melanoma stage ≥ T1b)
- Obtained signed informed consent
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| Blood samplesBlood samples | Procedure or surgery | Patients with melanoma |
Primary outcome
Neutrophil-to-lymphocyte ratio
Time frame: 1 Day
Ratio between neutrophil granulocytes and lymphocytes
2 secondary outcomes
Pro-inflammatory cytokines
Time frame: 1 Day
Acute phase reactants
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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?
An observational study of Melanoma and Surgery, run by Aalborg University Hospital 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 4 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: finished, as of the sponsor's last update on 18 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Neutrophil-to-lymphocyte ratio (time frame: 1 Day). It is what the study was designed to measure, not a finding.
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 18 Apr 2023.