Clinical trial · Observational
Study of Tumor Tissue Samples From Patients With Stage I, Stage II, or Stage III Malignant Melanoma
Identification of Genomic Lesions Promoting Nodal Metastasis in Malignant Melanoma
NCT00991991CI-TRIAL-00022216terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not enough tissue for analysis
Summary
Brief summary (as posted)
RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. PURPOSE: This research study is looking at tumor tissue samples from patients with stage I, stage II, or stage III malignant melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gene expression analysis | Genetic | — | UNRESOLVED |
| matrix-assisted laser desorption/ionization time of flight mass spectrometry | Other | — | UNRESOLVED |
| medical chart review | Other | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement
- timeFrame
- at the time of presentation
- measure
- Comparison of genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement
- timeFrame
- at the time of presentation
- measure
- Combinations of genetic lesions that correlate with nodal metastasis
- timeFrame
- at the time of presentation
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria:
* Node positive Group (experimental group)
* Primary melanoma \> 2 mm in depth
* Metastasis must be \> 0.1 mm and detectable by IHC or hematoxylin and eosin (H\&E) to be considered node positive
* Slides and block for primary and node must be archived in UH dermatopathology
* Node Negative Group (control group)
* Primary melanoma \> 2 mm in depth
* A negative sentinel lymph node must be negative by IHC and H\&E
* No stage IV disease
* No acral and mucosal histology
* No history of prior invasive melanoma
* Underwent primary excision and sentinel lymph node biopsy within 3 months of each other
* Archived tissue available
* Slides and block for primary tumor and node biopsy must be archived in University Hospitals Case Medical Center (UH) dermatopathology
Exclusion Criteria:
* Acral and mucosal histology
* Previous diagnosis of invasive melanoma
* previous chemotherapy or immunotherapy
* patients who are found to have stage IV disease during workupReferences
Publications (0)
Data not yet available
No reference posted for this study.