RECRUITING

Evaluation of Hypoxia in Primary Melanoma

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Conditions

MelanomaMelanoma in-transit metastases (ITMs)intra-nodal hypoxiaTumor cell oxidative metabolism (OCR)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

When controlling for tumor present in the Sentinel lymph node (SLN), intranodal hypoxia, as measured by Carbonic Anhydrase IX (CAIX IHC), is associated with worse PFS. This suggests that melanoma tumors may be utilizing deregulated metabolism as a means of propagating themselves to the next station of metastasis. This study aims to prospectively validate previous findings. Patients who are to undergo WLE and SLNB per standard of care (SOC) will be evaluable. It is hypothesized that SLN(s) with increased hypoxia, as measured by pimonidazole staining, will be associated with worse Progression-free Survival (PFS).

Official Title

Prospective Evaluation of Hypoxia in Primary Melanoma

Quick Facts

Study Start:2025-04-09
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06831071

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Must be willing and able to provide written informed consent for the study.
  2. 2. Must have histologically confirmed melanoma for which a Sentinel Lymph Node Biopsy (SLNB) is indicated per the treating physician.
  3. 3. Cutaneous or mucosal melanoma is permitted.
  4. 4. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days from the time of pimonidazole administration.
  5. 1. Female subjects of childbearing potential must not be pregnant or breastfeeding. Female subjects will be considered of non-reproductive potential if they:
  6. 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.
  7. 2. have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening.
  8. 3. have a congenital or acquired condition that prevents childbearing.
  9. 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:
  10. 1. practice abstinence from heterosexual activity
  11. 2. use (or have their partner use) acceptable contraception during heterosexual activity.
  12. 5. Adequate hematologic function: white blood cells (WBC) ≥ 2,500/μL, platelet count ≥ 100,000/μL, hemoglobin ≥ 8.0 g/dL
  13. 6. Adequate renal function: serum creatinine ≤ 2.0 mg/dL
  14. 7. Adequate hepatic function: serum alkaline phosphatase, bilirubin, and ALT ≤ twice the institutional upper limit of normal
  1. 1. Subjects with known chronic immunosuppression (such as biologic agents like infliximab, mycophenolate, methotrexate, prednisone \> 20 mg daily).
  2. 2. Severe septicemia or severe infection in the 4 weeks prior to study entry.
  3. 3. History of previous neuropathy from chemotherapy or other causes not related to cancer.
  4. 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. 5. Subjects with (ECOG) Performance scale of 4 - subjects unable to perform self-care.
  6. 6. Subjects who have received an investigational new drug 6 half-lives or two weeks prior to enrollment in this study, whichever is shorter.

Contacts and Locations

Study Contact

Danielle L Bednarz, RN, BSN
CONTACT
4126231191
bednarzdl@upmc.edu
Amy Rose, RN, BSN
CONTACT
412-647-8587
kennaj@upmc.edu

Principal Investigator

Yana M Najjar, MD
PRINCIPAL_INVESTIGATOR
UPMC Hillman Cancer Center

Study Locations (Sites)

UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States

Collaborators and Investigators

Sponsor: Yana Najjar

  • Yana M Najjar, MD, PRINCIPAL_INVESTIGATOR, UPMC Hillman Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-09
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2025-04-09
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • Melanoma in-transit metastases (ITMs)
  • intra-nodal hypoxia
  • Tumor cell oxidative metabolism (OCR)

Additional Relevant MeSH Terms

  • Melanoma