Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/22/2018 |
| Start Date: | October 3, 2017 |
| End Date: | December 2020 |
| Contact: | Clinical Trials Information Program |
| Email: | cip@vanderbilt.edu |
| Phone: | 800-811-8480 |
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.
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.
- Evaluate the diagnostic efficacy of a circulating melanoma gene signature in
pathologically verified Stage III melanoma at diagnosis (biopsy-proven lymph node
positive) and compare this to LDH as a biomarker.
- Evaluate the diagnostic efficacy of a circulating melanoma gene signature in
pathologically verified Stage IV melanoma (including pre-surgery patients as well as
those on either targeted or immunotherapy) and compare this to LDH as a biomarker.
- Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and
IV tumors.
- Monitor molecular signature levels in blood to assess efficacy of this tool as compared
to imaging or other biomarkers to define disease progression or treatment responses in
Stage III and IV treated patients.
pathologically verified Stage III melanoma at diagnosis (biopsy-proven lymph node
positive) and compare this to LDH as a biomarker.
- Evaluate the diagnostic efficacy of a circulating melanoma gene signature in
pathologically verified Stage IV melanoma (including pre-surgery patients as well as
those on either targeted or immunotherapy) and compare this to LDH as a biomarker.
- Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and
IV tumors.
- Monitor molecular signature levels in blood to assess efficacy of this tool as compared
to imaging or other biomarkers to define disease progression or treatment responses in
Stage III and IV treated patients.
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%
We found this trial at
1
site
2220 Pierce Ave
Nashville, Tennessee 37232
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Rondi Kauffmann, MD
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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