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Sentinel Node and Non-Sentinel Lymph Nodes (SLN and Non-SLN) Procurement From Melanoma Subjects for Molecular Profiling Analysis


N/A
12 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

Sentinel Node and Non-Sentinel Lymph Nodes (SLN and Non-SLN) Procurement From Melanoma Subjects for Molecular Profiling Analysis


Inclusion Criteria:



- Primary melanoma with the following Breslow thickness and stage

- ≥ 2 mm with ulceration, T3b

- ≥ 4 mm without (T4a) or with (T4b) ulceration

- Patients with a biopsied tumor that has not been widely resected will also be
eligible for study according to the above-specified criteria for tumor thickness
and stage.

- Age 12 years or older.

- Patients must have documented hemoglobin level of 10g/dL or higher. This can be drawn
on the day of consent, or be documented from a previous visit within the past 30 days

- Subjects must have provided written, informed consent prior to any study procedures:
collection of blood and LN tissue specimens for this protocol.

Exclusion Criteria:

- Serious illnesses that may be considered a contraindication to surgery as determined
by the physician investigator. If a subject is cleared for surgery as clinically
indicated (wide excision of the primary melanoma and sentinel lymph node biopsy),
subject would be eligible.

- Any significant psychiatric disease, medical intervention, or other condition, which
in the opinion of the Principal Investigator or Co-Investigators, could prevent
adequate informed consent or compromise participation in the clinical trial.

- Active infection or antibiotics within one-week prior to study

- Systemic steroid or other immunosuppressive therapy administered for more than 10
days within 4 weeks of enrollment.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

Molecularly characterize the regional nodal status of positive and negative SLNs (SLN+ and SLN-) in patients undergoing SLN mapping and dissection for routine staging of melanoma.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Ahmad Tarhini, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Institutional Review Board

Study ID:

07-133

NCT ID:

NCT00889980

Start Date:

May 2008

Completion Date:

May 2015

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

Hillman Cancer CenterPittsburg, Pennsylvania  15232