MelanomaNCT03267381
Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy
An observational study of Melanoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Blood draw (before surgery), Blood draw (every 3 months) and Blood draw (at diagnosis)
- Type of treatment
- Injection or infusion
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2017to 27 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with a diagnosis of stage III or IV melanoma.
Who may be able to join
- Age > 18 years
- Primary melanoma > 1 mm in Breslow depth
- 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
Who cannot join
- Pregnant patients
- Contraindication to contrasted imaging (due to allergy or renal insufficiency)
- Serum PCV <30%
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
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.
Read the 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.
- Conditions
- Melanoma
- Being tested
- Blood draw (before surgery), Blood draw (every 3 months), Blood draw (at diagnosis)
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw (before surgery)Other
Blood will be drawn before surgery
Blood draw (every 3 months)Other
Blood will be drawn every 3 months
Blood draw (at diagnosis)Other
Blood will be drawn at time of diagnosis
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Blood draw (before surgery); Other: Blood draw (every 3 months) | |
| Arm 1b | Stage III after sentinel node biopsy (microscopic disease diagnosed on sentinel node biopsy). Receives: Other: Blood draw (before surgery); Other: Blood draw (every 3 months) | |
| Arm 2 | Stage IV- will need to stratify by current treatment with immunotherapy, targeted therapy, none Receives: Other: Blood draw (before surgery); Other: Blood draw (at diagnosis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (stage III)
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.
Measured: Up to 24 months
Assay Metrics
Define the assay metrics for sensitivity and specificity in diagnosis in Stage III and IV tumors.
Measured: Up to 24 months
Molecular signature levels
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.
Measured: Up to 24 months
Efficacy (Stage IV)
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
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start3 Oct 2017
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wren Laboratories LLC
- Responsible party
- Principal investigator, Rondi Kauffmann, Vanderbilt-Ingram Cancer Center
- Investigators
- Rondi Kauffmann, MD, Principal investigator, vanderbilt Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267381
- Sponsor's protocol ID
- VICC MEL 1783
- Status last verified
- Dec 2023
- First submitted
- 25 Aug 2017
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Blood Profile to Predict Recurrence and Response to Systemic Therapy
- ClinicalTrials.gov ID
- NCT03267381
- Acronym / sponsor ID
- VICC MEL 1783
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- Wren Laboratories LLC
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1a | – | Other: Blood draw (before surgery), Other: Blood draw (every 3 months)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). |
| Arm 1b | – | Other: Blood draw (before surgery), Other: Blood draw (every 3 months)Stage III after sentinel node biopsy (microscopic disease diagnosed on sentinel node biopsy). |
| Arm 2 | – | Other: Blood draw (before surgery), Other: Blood draw (at diagnosis)Stage IV- will need to stratify by current treatment with immunotherapy, targeted therapy, none |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a diagnosis of stage III or IV melanoma.
Key inclusion criteria (3 listed)
- Age > 18 years
- Primary melanoma > 1 mm in Breslow depth
- 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
Key exclusion criteria (3 listed)
- Pregnant patients
- Contraindication to contrasted imaging (due to allergy or renal insufficiency)
- Serum PCV <30%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw (before surgery)Blood will be drawn before surgery | Other | Arm 1a, Arm 1b, Arm 2 |
| Blood draw (every 3 months)Blood will be drawn every 3 months | Other | Arm 1a, Arm 1b |
| Blood draw (at diagnosis)Blood will be drawn at time of diagnosis | Other | Arm 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
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Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rondi Kauffmann, MD principal investigator
vanderbilt Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (stage III) (time frame: Up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.