MelanomaNCT01205815
Storage and Research Use of Human Bio-specimens From Melanoma Patients and Clinical Testing for Assignment of Treatment
An observational study of Melanoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
The purpose of this research is to identify biological characteristics occurring in the initiation and progression of melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Tissue and blood collection
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2010to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with melanoma.
Who may be able to join
- Pathologically-proven diagnosis of melanoma.
- Patient must have a test or procedure that has the potential to provide left-over tissue that can be banked for future research purposes OR the patient has already had a diagnostic or therapeutic procedure but who has not yet been approached to participate is also eligible.
Who cannot join
- Any patient with significant contraindications to venipuncture (e.g., severe anemia) will be excluded from blood collection procedures. However, if the patient provides consent and a paraffin-embedded block or 10-15 unstained slides of their tissue diagnosis, they will not be excluded from this protocol.
- Any patient unable or unwilling to provide consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vanderbilt-Ingram Service for Timely Access contact
United States1 site, 1 recruiting
- Recruiting
Vanderbitl-Ingram Cancer Center
Nashville, Tennessee
Vanderbilt-Ingram Service for Timely Access, 800-811-8480
Douglas Johnson, MD
About this study
The purpose of this research is to identify biological characteristics occurring in the initiation and progression of melanoma.
- Conditions
- Melanoma
- Being tested
- Tissue and blood collection
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue and blood collectionOther
Tissue will be obtained from a previous biopsy if available, or if unavailable, tissue will be collected from a scheduled biopsy. About3-4 teaspoons of blood will be collected.
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular changes in patients' melanoma tissue
Tissue is collected upon consent or upon receipt of parafin block, primary aim will be met when all tissues are collected and analyzed at conclusion of study. Intent is to aid patients and their treating physician when making treatment decisions.
Measured: at 120 months
Secondary outcomes (1)
Improve the time between ordering the test and results entry into medical records
To enhance the speed and detail of molecular mutation profiling of melanoma
Measured: 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study start3 Jun 2010
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Johnson, Vanderbilt-Ingram Cancer Center
- Investigators
- Douglas Johnson, M.D., Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205815
- Sponsor's protocol ID
- VICC MEL 09109
- Status last verified
- Mar 2025
- First submitted
- 17 Sep 2010
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Yan C, Saleh N, Yang J, Nebhan CA, Vilgelm AE, Reddy EP, Roland JT, Johnson DB, Chen SC, Shattuck-Brandt RL, Ayers GD, Richmond A. Novel induction of CD40 expression by tumor cells with RAS/RAF/PI3K pathway inhibition augments response to checkpoint blockade. Mol Cancer. 2021 Jun 6;20(1):85. doi: 10.1186/s12943-021-01366-y.
PubMed 34092233
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Storage and Research Use of Human Bio-specimens From Melanoma Patients and Clinical Testing for Assignment of Treatment
- ClinicalTrials.gov ID
- NCT01205815
- Acronym / sponsor ID
- VICC MEL 09109
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Study start
- 3 Jun 2010 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Sep 2010 (estimated)
- 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.
The purpose of this research is to identify biological characteristics occurring in the initiation and progression of melanoma.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with melanoma.
Key inclusion criteria (2 listed)
- Pathologically-proven diagnosis of melanoma.
- Patient must have a test or procedure that has the potential to provide left-over tissue that can be banked for future research purposes OR the patient has already had a diagnostic or therapeutic procedure but who has not yet been approached to participate is also eligible.
Key exclusion criteria (2 listed)
- Any patient with significant contraindications to venipuncture (e.g., severe anemia) will be excluded from blood collection procedures. However, if the patient provides consent and a paraffin-embedded block or 10-15 unstained slides of their tissue diagnosis, they will not be excluded from this protocol.
- Any patient unable or unwilling to provide consent.
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 |
|---|---|---|
| Tissue and blood collectionTissue will be obtained from a previous biopsy if available, or if unavailable, tissue will be collected from a scheduled biopsy. About3-4 teaspoons of blood will be collected. | Other | – |
Primary outcome
Molecular changes in patients' melanoma tissue
Time frame: at 120 months
Tissue is collected upon consent or upon receipt of parafin block, primary aim will be met when all tissues are collected and analyzed at conclusion of study. Intent is to aid patients and their treating physician when making treatment decisions.
1 secondary outcome
Improve the time between ordering the test and results entry into medical records
Time frame: 120 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 34092233Yan C, Saleh N, Yang J, Nebhan CA, Vilgelm AE, Reddy EP, Roland JT, Johnson DB, Chen SC, Shattuck-Brandt RL, Ayers GD, Richmond A. Novel induction of CD40 expression by tumor cells with RAS/RAF/PI3K pathway inhibition augments response to checkpoint blockade. Mol Cancer. 2021 Jun 6;20(1):85. doi: 10.1186/s12943-021-01366-y.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink provided by the sponsor.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
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.
Vanderbilt-Ingram Service for Timely Access contact
Douglas Johnson, M.D. principal investigator
Vanderbilt-Ingram Cancer 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 19 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanderbilt-Ingram Service for Timely Access (800-811-8480), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular changes in patients' melanoma tissue (time frame: at 120 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01205815, which also lists 1 linked publication.
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 19 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.