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Cohort 3 for Skin Cancer

N/A

Recruiting

Led By Todd Tenenholz, MD

Research Sponsored by West Virginia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Visible tumor (primary or metastasis) involving the skin of at least 6 mm in diameter

Pathology-proven (histology or cytology) malignancy of any histology and site of origin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the first oxygen measurement to one month after the completing standard therapy

Awards & highlights

Study Summary

This trial aims to measure different types of skin tumors to see how they respond to hyperoxygenation therapy and standard cancer treatments. The goal is to test whether a technique called Electron Paramagnetic Reson

Who is the study for?

This trial is for individuals with confirmed skin cancer of any type, where the tumor is visible on the skin and at least 6 mm wide. Women who can have children must show a negative pregnancy test within three days before joining.Check my eligibility

What is being tested?

The study measures oxygen levels in skin tumors using a technique called Electron Paramagnetic Resonance (EPR) Oximetry. It aims to see if this method can track changes in tumor oxygen after receiving extra oxygen therapy or standard cancer treatments.See study design

What are the potential side effects?

Since the intervention involves measuring oxygen levels rather than administering drugs, there are no direct side effects from medications. However, discomfort or other minor issues related to the measurement process may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a visible skin tumor that is at least 6 mm wide.

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My cancer's type and origin have been confirmed by lab tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the first oxygen measurement to one month after the completing standard therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the first oxygen measurement to one month after the completing standard therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first oxygen measurement to one month after the completing standard therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess the change in oxygenation of cutaneous tumors from hyperoxygenation therapy during the standard therapy for the disease

Secondary outcome measures

To characterize temporal variations in oxygenation of cutaneous tumors over a course of local radiation therapy and/or systemic chemotherapy or immunotherapy

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment1 Intervention

Patients who will receive systemic therapy alone (without radiation) for any tumor involving the skin, will have their tumor injected with India ink for tumor marking and will be given oxygen during the measurement sessions.

Group II: Cohort 3Experimental Treatment1 Intervention

Patients who will receive palliative radiation (+/- concurrent systemic therapy) for any tumor involving the skin, will have their tumor injected with India ink for tumor marking and will be given oxygen during the measurement sessions.

Group III: Cohort 2Experimental Treatment1 Intervention

Patients who will receive definitive radiation (+/- concurrent systemic therapy) for a primary malignancy of the skin, will have their tumor injected with India ink for tumor marking and will be given oxygen during the measurement sessions.

Group IV: Cohort 1Experimental Treatment1 Intervention

Patients who will receive definitive surgery for a primary malignancy of the skin, will have their tumor injected with India ink for tumor marking and will be given oxygen during the measurement sessions.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

West Virginia UniversityLead Sponsor

176 Previous Clinical Trials

60,174 Total Patients Enrolled

West Virginia Clinical and Translational Science InstituteOTHER

7 Previous Clinical Trials

60 Total Patients Enrolled

Mary Babb Randolph Cancer Center at West Virginia University HospitalsOTHER

1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in this medical research study?

"Patients who are between the ages of 18 and 90 and have been diagnosed with skin cancer may be eligible to participate in this clinical trial. The study aims to recruit a total of 40 patients."

Answered by AI

Are new participants still being accepted for enrollment in this ongoing research study?

"According to the details provided on clinicaltrials.gov, this medical trial is currently seeking eligible participants. The trial was first posted on October 17th, 2019 and has been recently updated as of January 10th, 2024."

Answered by AI

What is the current number of individuals being admitted into this particular medical trial?

"Indeed, the information available on clinicaltrials.gov strongly indicates that this particular study is currently actively seeking eligible candidates. The trial was initially posted on October 17th, 2019 and has most recently been updated on January 10th, 2024. In order to complete the trial successfully, a total of 40 participants are needed from two distinct sites."

Answered by AI