NCT04658303 Evolution of Metabolic and Immune Dysfunction in In-transit Melanoma
| NCT ID | NCT04658303 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yana Najjar |
| Condition | Melanoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-02-24 |
| Primary Completion | 2029-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2021-02-24 with a primary completion date of 2029-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Melanoma in-transit metastases (ITMs) continue to represent a therapeutic dilemma, in that no standard method of treatment has been uniformly adopted. The complexity and heterogeneity of patient and disease characteristics, including the location and number of ITMs presents a barrier to a one size fits all treatment approach. Treatment of patients with limited regional disease remains challenging. Patients are typically treated with a combination of surgery, regional therapy, systemic therapy. Data on the management of ITMs is limited, even with the availability of immunotherapy (IMT). This study will use the unique etiology of ITMs to facilitate the understanding of how individual lesions metabolically and immunologically evolve as they move away from the primary tumor site. It is hypothesize that as ITMs move away from the primary melanoma site each will harbor progressively hypermetabolic tumor cells and a harsher microenvironment.
Eligibility Criteria
Inclusion Criteria: 1. Be willing and able to provide written informed consent for the trial. 2. Be ≥ 18 years of age on day of signing informed consent. 3. A histological diagnosis of melanoma and at least two in-transit lesions at distinct distances from the primary site. Patients may be enrolled on the basis of a diagnosis of in-transit disease by a treating melanoma oncologist. 4. Cutaneous, mucosal or uveal melanoma are permitted. 5. Patients may be on treatment or treatment naïve. 6. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days from the time of pimonidazole administration. Exclusion Criteria: 1. Subjects with in-transit disease that is not amenable to biopsy per the treating physician are excluded. 2. Subjects with known chronic immunosuppression (such as biologic agents like remicade, mycophenolate, methotrexate, prednisone \>20 mg daily). 3. Subjects who are known to be HIV+, Hep B or Hep C positive.
Contact & Investigator
Yana Najjar, MD
PRINCIPAL INVESTIGATOR
UPMC Hillman Cancer Center
Frequently Asked Questions
Who can join the NCT04658303 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04658303 currently recruiting?
Yes, NCT04658303 is actively recruiting participants. Contact the research team at bednarzdl@upmc.edu for enrollment information.
Where is the NCT04658303 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT04658303 clinical trial?
NCT04658303 is sponsored by Yana Najjar. The principal investigator is Yana Najjar, MD at UPMC Hillman Cancer Center. The trial plans to enroll 20 participants.
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