Clinical trial · Observational
Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy
NCT03267381CI-TRIAL-00072265completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To study if a targeted gene expression profile of RNA, similar to the NETest, can be isolated from the peripheral blood of patients with melanoma, to identify active disease, provide an assessment of treatment responses, or predict risk of relapse, in conjunction with standard clinical assessment and imaging.
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 | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw (at diagnosis) | Other | — | UNRESOLVED |
| Blood draw (before surgery) | Other | — | UNRESOLVED |
| Blood draw (every 3 months) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Arm 1a
- description
- Stage III melanoma diagnosis (biopsy-proven lymph node positive (this is either clinically palpable or enlarged nodes detected by imaging, which are then biopsied and have macroscopic disease).
- interventionNames
- Other: Blood draw (before surgery)
- Other: Blood draw (every 3 months)
- label
- Arm 1b
- description
- Stage III after sentinel node biopsy (microscopic disease diagnosed on sentinel node biopsy).
- interventionNames
- Other: Blood draw (before surgery)
- Other: Blood draw (every 3 months)
- label
- Arm 2
- description
- Stage IV- will need to stratify by current treatment with immunotherapy, targeted therapy, none
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \> 18 years 2. Primary melanoma \> 1 mm in Breslow depth 3. Stage III or IV disease as determined either by sentinel node biopsy, biopsy of clinically enlarged lymph nodes, and/or imaging. If stage IV, must have tissue biopsy confirming presence of stage IV melanoma Exclusion Criteria: 1. Pregnant patients 2. Contraindication to contrasted imaging (due to allergy or renal insufficiency) 3. Serum PCV \<30%
References
Publications (0)
Data not yet available
No reference posted for this study.