Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

• Sponsor: Vanderbilt-Ingram Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03267381
• Collaborator: Wren Laboratories LLC (Industry)
• Enrollment: 37
• Location: 1
• Anticipated Duration (Months): 81.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Melanoma	Other: Blood draw (before surgery); Other: Blood draw (every 3 months); Other: Blood draw (at 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 37 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy
• Actual Study Start Date: Oct 3, 2017
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Efficacy (stage III) [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.

2. Assay Metrics [Up to 24 months]

   Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors.

3. Molecular signature levels [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.

4. Efficacy (Stage IV) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Vanderbilt-Ingram Cancer Center
• Wren Laboratories LLC

Investigators

• Principal Investigator: Rondi Kauffmann, MD, vanderbilt Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rondi Kauffmann, Principal Investigator, Vanderbilt-Ingram Cancer Center
• ClinicalTrials.gov Identifier: NCT03267381
• Other Study ID Numbers: VICC MEL 1783
• First Posted: Aug 30, 2017
• Last Update Posted: Oct 4, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Recurrence

Study Results

No Results Posted as of Oct 4, 2021