ClinicalTrials.gg
Not yet recruitingNCT07934550Updated Nov 13, 2026

Prospective, Multi-Center Observational Registry of Melanoma CP-GEP and Clinical Outcomes

An observational study in Melanoma (Skin Cancer) and Gene Expression Profiling, sponsored by SkylineDx. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by SkylineDx · Observational

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
65 Years and older
Sex
All
01

Study summary

The purpose of the registry is to understand how Merlin CP-GEP testing is used in routine care and whether the test result is associated with clinical decision-making in people with melanoma who are 65 years of age or older. The study will also collect available information about treatment decisions and clinical outcomes over time.

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Conditions studied

  • Melanoma (Skin Cancer)
  • Gene Expression Profiling

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Keywords

  • Melanoma
  • Registry
  • Merlin CP-GEP
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In context

Melanoma

3,370 studies on the registry are indexed under Melanoma; 578 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 187 across 488 observational studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

SkylineDx is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Melanoma patients 65 years of age and older who were tested with the Merlin CP-GEP and obtained a valid result.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Newly diagnosed invasive malignant melanoma of the skin (AJCC 8th edition staging guidelines).
  • pT1-pT4 cN0M0
  • Male or female, age ≥65 years.
  • Merlin CP-GEP testing performed, and a valid result obtained.
  • Ability to provide , or availability of a legally authorized representative when permitted by applicable law and institutional policy.

Exclusion criteria

Exclusion Criteria:

  • Documented clinically apparent nodal at diagnosis.
  • Distant metastatic disease (M1a, M1b, M1c, or M1d) clinically present at primary diagnosis.
  • Documented history of another (prior or concurrent) primary invasive melanoma of T1a or greater at any site in their lifetime.
  • Previous surgery or radiation therapy to the draining lymph node basin(s) of the current primary melanoma.
  • Ocular, vulvar, perianal, or mucosal melanomas, or melanocytic tumors of uncertain malignant potential (MELTUMP) or atypical Spitz tumors.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Newly diagnosed primary cutaneous melanoma patients

    Newly diagnosed primary cutaneous melanoma patients, 65 years of age and older, with a valid Merlin CP-GEP result.

06

What researchers measure

Primary outcomes

  1. Proportion of patients aged 65 years and older with documented integrated use of the Merlin CP-GEP result in clinical decision-making.

    Clinical impact of the Merlin CP-GEP, evaluated by the percentage of participants aged 65 years and older whose medical records show documented integration of the assay result into clinical management decisions. Documented clinical decision-making includes decisions concerning sentinel lymph node biopsy (SLNB), subsequent surveillance schedules, diagnostic imaging, or adjuvant therapy.

    Time frame: Clinical data will be collected prospectively for up to three years from enrollment.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Jan 2029, 24 months later.

Of 59 industry-sponsored observational studies under Melanoma, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 80. This study's planned 24 months is below that.

Counting every sponsor, half of 236 studies reached it within 71 months; a quarter within 35 and three quarters within 248.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2026
First posted
Nov 13, 2026
StartEst.
Jan 2027
Primary completionEst.
Jan 2029
CompletionEst.
Jan 2032
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07934550
Lead sponsor
SkylineDx
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jan 2029 (estimated)
Completion
Jan 2032 (estimated)
Last update
Nov 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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