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Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified August 2017 by Rondi Kauffmann, Vanderbilt-Ingram Cancer Center
Sponsor:
Collaborator:
Wren Laboratories LLC
Information provided by (Responsible Party):
Rondi Kauffmann, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT03267381
First received: August 25, 2017
Last updated: August 25, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention
Melanoma Other: Blood draw (before surgery) Other: Blood draw (every 3 months) Other: Blood draw (at diagnosis)

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

Resource links provided by NLM:


Further study details as provided by Rondi Kauffmann, Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Efficacy (stage III) [ Time Frame: Up to 24 months ]
    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.

  • Assay Metrics [ Time Frame: Up to 24 months ]
    Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors.

  • Molecular signature levels [ Time Frame: Up to 24 months ]
    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.

  • Efficacy (Stage IV) [ Time Frame: Up to 24 months ]
    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


Estimated Enrollment: 30
Anticipated Study Start Date: October 2017
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm 1a
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).
Other: Blood draw (before surgery)
Blood will be drawn before surgery
Other: Blood draw (every 3 months)
Blood will be drawn every 3 months
Arm 1b
Stage III after sentinel node biopsy (microscopic disease diagnosed on sentinel node biopsy).
Other: Blood draw (before surgery)
Blood will be drawn before surgery
Other: Blood draw (every 3 months)
Blood will be drawn every 3 months
Arm 2
Stage IV- will need to stratify by current treatment with immunotherapy, targeted therapy, none
Other: Blood draw (before surgery)
Blood will be drawn before surgery
Other: Blood draw (at diagnosis)
Blood will be drawn at time of diagnosis

Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with a diagnosis of stage III or IV melanoma.
Criteria

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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03267381

Contacts
Contact: Clinical Trials Information Program 800-811-8480 cip@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Rondi Kauffmann         
Principal Investigator: Rondi Kauffmann, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Wren Laboratories LLC
Investigators
Principal Investigator: Rondi Kauffmann, MD vanderbilt Medical Center
  More Information

Responsible Party: Rondi Kauffmann, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT03267381     History of Changes
Other Study ID Numbers: VICC MEL 1783
Study First Received: August 25, 2017
Last Updated: August 25, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Recurrence
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 19, 2017