Melanoma (Skin Cancer)ROTATENCT07293598
Investigation of the ROle of faT and inflAmmaTory Cells in mElanoma
An observational study of Melanoma (Skin Cancer), run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study is a retrospective, proof-of-concept sample study to investigate a novel histological finding within the primary melanoma tumour in a large population of melanoma patients to assess its prognostic significance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma (Skin Cancer)
- What is being tested?
- Sample analysis only
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Sample analysis of melanoma only
Who may be able to join
- Melanomas treated between 1st January 2006 and 31st December 2015 OR
- Patients treated at the Christie between 2014 and 2019.
- Review of histological slides for presence or absence of relevant histological features.
- For group 3 and group 4:
- Unique features of spitzoid melanomas
Who cannot join
- Inadequate slide quality
- Unable to view the entire cross section of the skin with the primary tumour hence, unable to assess the invasion of inflammatory cells into fat
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester
Richa Garva, Dr, 01614469999, removed_due_to_spam@email.com
About this study
Official title: A Clinical, Histological, Cellular and Molecular Investigation of the Role of Fat and Inflammatory Cells in Melanoma Plasticity and Metastases
This study is a retrospective, proof-of-concept sample study to investigate a novel histological finding within the primary melanoma tumour in a large population of melanoma patients to assess its prognostic significance.
This is a aims to validate the striking observation that a cross-talk between fat cells and leukocytes at the primary melanoma site promotes metastasis. In our unpublished pilot study, we have discovered an interesting finding whereby inflammatory cells extend from the tumour to and invading fat in the subcutaneous tissue and/or around the appendageal structures in the dermal skin in metastatic melanomas with distinct architectural changes within the fat. This finding was consistently present in metastatic and absent in non-metastatic melanomas. This new finding has both clinical and pathophysiological credence. Archival tissue blocks or human cell lines will be used in the first instance. As mitigation, experiments will be repeated with conditioned media obtained from co-culture of mixed primary immune cells obtained from peripheral blood mononuclear cell (PBMCs) and adipocytes induced from stem cells.
Read more
This study aims to:
- Investigate if the crosstalk between fat cells and tumour-infiltrating inflammatory cells defines the aggressiveness of primary cutaneous melanomas.
- Identify and perform biological spatial analysis of the inflammatory cells between the tumour and fat in the primary tumours.
- Investigate the interactions of fat cells and/or inflammatory cells in mediating melanoma cellular plasticity.
The patients have not provided consent and will be justified in this application
- Conditions
- Melanoma (Skin Cancer)
- Being tested
- Sample analysis only
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample analysis onlyOther
Sample analysis only
What is being measured
The primary outcome is the main question the study is designed to answer.
What is the predictive accuracy of inflammatory cell invasion into the subcutaneous fat layer in primary melanoma for determining the risk of metastasis and/or disease progression?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293598
- Sponsor's protocol ID
- CFTSp252
- Acronym
- ROTATE
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 19 Dec 2025
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical, Histological, Cellular and Molecular Investigation of the Role of Fat and Inflammatory Cells in Melanoma Plasticity and Metastases
- ClinicalTrials.gov ID
- NCT07293598
- Acronym / sponsor ID
- ROTATE / CFTSp252
- Conditions
- Melanoma (Skin Cancer)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 19 Dec 2025 (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.
This study is a retrospective, proof-of-concept sample study to investigate a novel histological finding within the primary melanoma tumour in a large population of melanoma patients to assess its prognostic significance.
This is a aims to validate the striking observation that a cross-talk between fat cells and leukocytes at the primary melanoma site promotes metastasis. In our unpublished pilot study, we have discovered an interesting finding whereby inflammatory cells extend from the tumour to and invading fat in the subcutaneous tissue and/or around the appendageal structures in the dermal skin in metastatic melanomas with distinct architectural changes within the fat. This finding was consistently present in metastatic and absent in non-metastatic melanomas. This new finding has both clinical and pathophysiological credence. Archival tissue blocks or human cell lines will be used in the first instance. As mitigation, experiments will be repeated with conditioned media obtained from co-culture of mixed primary immune cells obtained from peripheral blood mononuclear cell (PBMCs) and adipocytes induced from stem cells.
This study aims to:
- Investigate if the crosstalk between fat cells and tumour-infiltrating inflammatory cells defines the aggressiveness of primary cutaneous melanomas.
- Identify and perform biological spatial analysis of the inflammatory cells between the tumour and fat in the primary tumours.
- Investigate the interactions of fat cells and/or inflammatory cells in mediating melanoma cellular plasticity.
The patients have not provided consent and will be justified in this application
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sample analysis of melanoma only
Key inclusion criteria (5 listed)
- Melanomas treated between 1st January 2006 and 31st December 2015 OR
- Patients treated at the Christie between 2014 and 2019.
- Review of histological slides for presence or absence of relevant histological features.
- Unique features of spitzoid melanomas
Key exclusion criteria (2 listed)
- Inadequate slide quality
- Unable to view the entire cross section of the skin with the primary tumour hence, unable to assess the invasion of inflammatory cells into fat
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 |
|---|---|---|
| Sample analysis onlySample analysis only | Other | – |
Primary outcome
What is the predictive accuracy of inflammatory cell invasion into the subcutaneous fat layer in primary melanoma for determining the risk of metastasis and/or disease progression?
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 (Skin Cancer), run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 19 Dec 2025. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richa Garva, Dr (01614469999, removed_due_to_spam@email.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
What is the predictive accuracy of inflammatory cell invasion into the subcutaneous fat layer in primary melanoma for determining the risk of metastasis and/or disease progression? (time frame: 1 year). 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 19 Dec 2025.