Clinical trial · Observational
Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Melanoma
NCT03727087CI-TRIAL-00050005terminatedClinicalTrials.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): COVID-19
Summary
Brief summary (as posted)
The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Sample Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Melanoma
- description
- Subjects with clinically confirmed melanoma or high suspicion of a primary malignancy of melanoma based on skin exam or imaging and who are treatment naive will provide a blood sample at time of enrollment. No additional blood draws will occur.
- interventionNames
- Other: Blood Sample Collection
Primary outcomes (1)
- measure
- Blood-based biomarkers associated with genetic and epigenetic alterations.
- timeFrame
- Point in time blood collection (1 day) at enrollment
- description
- Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with melanoma at the pre-intervention stage.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is male or female \> 18 years of age. 2. Subject has an untreated primary melanoma. OR Subject has high suspicion of primary malignancy of melanoma based on skin exam or imaging. 3. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator. Exclusion Criteria: 1. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers). 2. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection. 3. Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery prior to blood sample collection. 4. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection. 5. Less than 5 days between biopsy (other than FNA) of target pathology and blood collection. 6. IV contrast (e.g. CT and MRI) within 1 day \[or 24 hours\] of blood collection. 7. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
References
Publications (0)
Data not yet available
No reference posted for this study.