MelanomaNCT00996827
Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma
An observational study of Melanoma, run by New Mexico Cancer Research Alliance at 2 sites in United States.
Trial summary
This project seeks to understand differences in the serum vitamin D levels and immune status in cutaneous malignant melanoma patients with different UV exposure histories in New Mexico. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Melanoma
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Dec 2013
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have recieved interferon or IL-2 therapy.
Who may be able to join
- Resident of New Mexico
- Age between the 1 and 95
- Newly diagnosed with cutaneous invasive melanoma; any stage permitted (ICDO C44.0-9) between September 1, 2008 and December 31, 2011.
- SSM (superficial spreading melanoma) and NM (nodular melanoma) histological subtypes are allowed
- Access to a telephone or be able to participate in a personal interview at the clinic
- Physically and mentally competent to complete a 1-hour telephone or personal interview
Who cannot join
- Ocular melanoma, LMM (lentigo maligna melanoma) or ALM (acral lentigo melanoma), and mucosal melanoma cases.
- No access to a telephone or is not able to meet with the interviewer.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lovelace Women's Hospial
Albuquerque, New Mexico, 87109
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
This project seeks to understand differences in the serum vitamin D levels and immune status in cutaneous malignant melanoma patients with different UV exposure histories in New Mexico.
Read the detailed description
It is well established that ultraviolet radiation (UV) exposure is related to the development of melanoma. There is also evidence that immune reactions are altered after UV exposure in the skin (locally) and perhaps throughout the body (systemically). Additionally, while the role of vitamin D and melanoma development has not been fully established, UV-B exposure is essential for vitamin D production in the skin. Increased sun exposure is also related to the presence of solar elastosis, which might protect (1) or improve survival from melanoma. Thus, melanoma represents a unique model for studying UV exposure, the immune system, and vitamin D. Malignant melanoma is an antigenic cancer; therefore, the role of UV exposure-induced immunosuppression and vitamin D production in the recognition, destruction and growth inhibition of cancerous melanocytes is worth further study.
To underscore the importance of this project, the Scientific Advisory Committee of the Melanoma Research Foundation and the Steering Committee of the Society of Melanoma Research have indicated a need to collect more human data on the host immune response mechanisms in melanoma and also to focus on the skin as a whole microenvironment, moving away from only in vitro experiments.
- Conditions
- Melanoma
- Keywords
- Melanoma, Skin cancer, Vitamin D, Vitamin D receptor, Sunlight, Cytokine
- Medical subject headings
- Melanoma, Skin Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
• Evaluate serum 25(OH)-vitamin D concentrations. • Detect the presence of solar elastosis and local immunosuppression in skin biopsy samples • Assess the role of the systemic humoral immune response
Measured: 1 year
Secondary outcomes (1)
• Evaluate cellular immunological changes of peripheral lymphocyte subpopulations • Sequence chromosome 6 from blood DNA samples of the patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2013
- Study completionDec 2013
Why it stopped: Sufficient samples collected when 73% of target enrollment was reached.
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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Montasur Shaheen, MD, Principal investigator, University of New MexicoMarianne Berwick, PhD, Study chair, University of New Mexico Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996827
- Sponsor's protocol ID
- INST 0815
- Status last verified
- Jun 2015
- First submitted
- 14 Oct 2009
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultraviolet Light Exposure and Immunosuppression in Cutaneous Melanoma
- ClinicalTrials.gov ID
- NCT00996827
- Acronym / sponsor ID
- INST 0815
- Conditions
- Melanoma
- Keywords
- Melanoma, Skin cancer, Vitamin D, Vitamin D receptor, Sunlight, Cytokine
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sufficient samples collected when 73% of target enrollment was reached.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Oct 2009 (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.
This project seeks to understand differences in the serum vitamin D levels and immune status in cutaneous malignant melanoma patients with different UV exposure histories in New Mexico.
Detailed description
It is well established that ultraviolet radiation (UV) exposure is related to the development of melanoma. There is also evidence that immune reactions are altered after UV exposure in the skin (locally) and perhaps throughout the body (systemically). Additionally, while the role of vitamin D and melanoma development has not been fully established, UV-B exposure is essential for vitamin D production in the skin. Increased sun exposure is also related to the presence of solar elastosis, which might protect (1) or improve survival from melanoma. Thus, melanoma represents a unique model for studying UV exposure, the immune system, and vitamin D. Malignant melanoma is an antigenic cancer; therefore, the role of UV exposure-induced immunosuppression and vitamin D production in the recognition, destruction and growth inhibition of cancerous melanocytes is worth further study.
To underscore the importance of this project, the Scientific Advisory Committee of the Melanoma Research Foundation and the Steering Committee of the Society of Melanoma Research have indicated a need to collect more human data on the host immune response mechanisms in melanoma and also to focus on the skin as a whole microenvironment, moving away from only in vitro experiments.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have recieved interferon or IL-2 therapy.
Key inclusion criteria (6 listed)
- Resident of New Mexico
- Age between the 1 and 95
- Newly diagnosed with cutaneous invasive melanoma; any stage permitted (ICDO C44.0-9) between September 1, 2008 and December 31, 2011.
- SSM (superficial spreading melanoma) and NM (nodular melanoma) histological subtypes are allowed
- Access to a telephone or be able to participate in a personal interview at the clinic
Key exclusion criteria (2 listed)
- Ocular melanoma, LMM (lentigo maligna melanoma) or ALM (acral lentigo melanoma), and mucosal melanoma cases.
- No access to a telephone or is not able to meet with the interviewer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• Evaluate serum 25(OH)-vitamin D concentrations. • Detect the presence of solar elastosis and local immunosuppression in skin biopsy samples • Assess the role of the systemic humoral immune response
Time frame: 1 year
1 secondary outcome
• Evaluate cellular immunological changes of peripheral lymphocyte subpopulations • Sequence chromosome 6 from blood DNA samples of the patients
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Sufficient samples collected when 73% of target enrollment was reached.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
- University of New Mexico Cancer CenterLink provided by the sponsor.
- New Mexico Cancer Care AllianceLink provided by the sponsor.
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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.
Montasur Shaheen, MD principal investigator
University of New Mexico
Marianne Berwick, PhD study chair
University of New Mexico Cancer Center
2 sites 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 New Mexico Cancer Research Alliance at 2 sites 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 6 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: stopped early, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Sufficient samples collected when 73% of target enrollment was reached.). Results are not available in the source record.
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?
• Evaluate serum 25(OH)-vitamin D concentrations. • Detect the presence of solar elastosis and local immunosuppression in skin biopsy samples • Assess the role of the systemic humoral immune response (time frame: 1 year). 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 18 Jun 2015.