Purpose of this Study
We are doing this study to find out if surgically removing only the cancerous lymph node (known as a lymph node excision) is effective at preventing melanoma from coming back in the same area of the lymph node excision. We also want to learn more about the side effects of this type of surgery and how it can impact patients' quality of life.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with melanoma that has spread to only one lymph node in the axilla (underarm area), groin, or iliac basin (pelvic region)</li>
<li>Are able to undergo lymph node excision</li>
<li>Have not had a lymph node dissection</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: chandler.warren@duke.edu"> chandler.warren@duke.edu.</a>
<li>Are diagnosed with melanoma that has spread to only one lymph node in the axilla (underarm area), groin, or iliac basin (pelvic region)</li>
<li>Are able to undergo lymph node excision</li>
<li>Have not had a lymph node dissection</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: chandler.warren@duke.edu"> chandler.warren@duke.edu.</a>
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will have your enlarged lymph node removed during your planned cancer removal surgery. We wil keep in touch with you after this surgery to keep tabs on how you are doing. During this time, you will:<ul>
<li>Have blood draws</li>
<li>Have physical exams</li>
<li>Have imaging scans (PET/CT and MRI)</li>
<li>Fill out surveys</li></ul>
<li>Have blood draws</li>
<li>Have physical exams</li>
<li>Have imaging scans (PET/CT and MRI)</li>
<li>Fill out surveys</li></ul>
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Lymph Node Excision (LNEx) for Patients with Stage III Melanoma with One Clinically Positive Node: Excision of Lymph Node Trial [EXCILYNT]
Principal Investigator
Jay
Lee
Protocol Number
PRO00114693
NCT ID
NCT05839912
Phase
II
Enrollment Status
Open to Enrollment