Evaluating hypoxia in primary melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to validate previous findings regarding the relationship between intra-nodal hypoxia and clinical outcomes in melanoma patients. It focuses on patients with early-stage melanoma who are undergoing standard procedures like wide local excision and sentinel lymph node biopsy. By analyzing banked samples and measuring hypoxia through carbonic anhydrase IX, the study seeks to determine if increased hypoxia correlates with worse progression-free survival. The goal is to understand how tumor metabolism may influence melanoma progression.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Must be willing and able to provide written informed consent for the study.
2. Must have histologically confirmed melanoma for which a Sentinel Lymph Node Biopsy (SLNB) is indicated per the treating physician.
3. Cutaneous or mucosal melanoma is permitted.
4. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days from the time of pimonidazole administration.

   1. Female subjects of childbearing potential must not be pregnant or breastfeeding. Female subjects will be considered of non-reproductive potential if they:

      1. are postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \< 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
      2. have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening.
      3. have a congenital or acquired condition that prevents childbearing.
   2. Female and male subjects of reproductive potential must agree to avoid becoming pregnant or impregnating a partner, respectively, while receiving study drug and 1 week after the dose of study drug for females and 2 weeks for males by complying with one of the following:

      1. practice abstinence from heterosexual activity
      2. use (or have their partner use) acceptable contraception during heterosexual activity.
5. Adequate hematologic function: white blood cells (WBC) ≥ 2,500/μL, platelet count ≥ 100,000/μL, hemoglobin ≥ 8.0 g/dL
6. Adequate renal function: serum creatinine ≤ 2.0 mg/dL
7. Adequate hepatic function: serum alkaline phosphatase, bilirubin, and ALT ≤ twice the institutional upper limit of normal

Exclusion Criteria:

1. Subjects with known chronic immunosuppression (such as biologic agents like infliximab, mycophenolate, methotrexate, prednisone \> 20 mg daily).
2. Severe septicemia or severe infection in the 4 weeks prior to study entry.
3. History of previous neuropathy from chemotherapy or other causes not related to cancer.
4. Pregnant subjects or breastfeeding subjects. (Note: A pregnancy test will be administered within 7 days prior to the administration of pimonidazole to female subjects of childbearing potential enrolled in the study.)
5. Subjects with (ECOG) Performance scale of 4 - subjects unable to perform self-care.
6. Subjects who have received an investigational new drug 6 half-lives or two weeks prior to enrollment in this study, whichever is shorter.

Where it's running

• UPMC Hillman Cancer Center
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Yana M Najjar, MD — UPMC Hillman Cancer Center
• Study coordinator: Danielle L Bednarz, RN, BSN
• Email: bednarzdl@upmc.edu
• Phone: 4126231191

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Melanoma treatment with immunotherapy guided by serial ctDNA testing

  This trial tests whether regular ctDNA blood tests during treatment can help tailor the plan for patients with advanced melanoma receiving nivolumab and ipilimumab.

  Recruiting Phase 2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT07930182

• Non-invasive skin-tape test to detect melanoma using methylation biomarkers

  A non-invasive skin-tape test is being tried to see if it can detect melanoma in people who are about to have a biopsy for a suspicious pigmented lesion.

  Recruiting at 4 sites Mitra Bio · Ghent and 4 other locations · NCT07883954

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• BL-M08D treatment in melanoma and other solid tumors

  A phase Ib/II study tests BL-M08D1 injections in adults with locally advanced or metastatic melanoma and other solid tumors to see if it is safe and helpful.

  Recruiting Phase 1/2 Sichuan Baili Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality · NCT07841925

• Aggressive lipid lowering in melanoma patients starting immune checkpoint therapy

  This trial tests whether lowering cholesterol aggressively can reduce heart artery disease risk in melanoma patients who are just beginning immune checkpoint therapy.

  Recruiting University of Colorado, Denver · Aurora, Colorado · NCT07704918

• Timing of Immunotherapy in Melanoma

  This trial tests whether starting standard melanoma immunotherapy earlier in the day (before 10 am) versus later in the day (after 1 pm) makes a difference for patients with unresectable or metastatic melanoma.

  Recruiting Radboud University Medical Center · Amsterdam and 4 other locations · NCT07696715

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.