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Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy

NCT ID: NCT03267381

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-03

Study Completion Date

2023-09-27

Brief Summary

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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.

Detailed Description

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* 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.

Conditions

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Melanoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Blood draw (before surgery)

Intervention Type OTHER

Blood will be drawn before surgery

Blood draw (every 3 months)

Intervention Type OTHER

Blood will be drawn every 3 months

Arm 1b

Stage III after sentinel node biopsy (microscopic disease diagnosed on sentinel node biopsy).

Blood draw (before surgery)

Intervention Type OTHER

Blood will be drawn before surgery

Blood draw (every 3 months)

Intervention Type OTHER

Blood will be drawn every 3 months

Arm 2

Stage IV- will need to stratify by current treatment with immunotherapy, targeted therapy, none

Blood draw (before surgery)

Intervention Type OTHER

Blood will be drawn before surgery

Blood draw (at diagnosis)

Intervention Type OTHER

Blood will be drawn at time of diagnosis

Interventions

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Blood draw (before surgery)

Blood will be drawn before surgery

Intervention Type OTHER

Blood draw (every 3 months)

Blood will be drawn every 3 months

Intervention Type OTHER

Blood draw (at diagnosis)

Blood will be drawn at time of diagnosis

Intervention Type OTHER

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wren Laboratories LLC

INDUSTRY

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Rondi Kauffmann

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rondi Kauffmann, MD

Role: PRINCIPAL_INVESTIGATOR

vanderbilt Medical Center

Locations

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Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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VICC MEL 1783

Identifier Type: -

Identifier Source: org_study_id