Detection of Melanoma Markers in Lymph Nodes or Periphera... | NCT00004153

Studies
Detection of Melanoma Markers in Lymph Nodes or Peripheral Blood of Patients With Melanoma

NCT00004153

Sponsor

University of Chicago

Status

Completed

Last Update Posted

Sep 5, 2013Estimated

Enrollment

106Actual

Phase

Not Applicable

Conditions

Melanoma (Skin)

Interventions

reverse transcriptase-polymerase chain reaction
sentinel lymph node biopsy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1998

Primary Completion Date

Mar 2004Actual

Completion Date

Jan 2005Actual

First Submitted Date

Dec 10, 1999

First Submission Date that Met QC Criteria

Jan 26, 2003

First Posted Date

Jan 27, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2013

Last Update Posted Date

Sep 5, 2013Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

RATIONALE: Diagnostic procedures may improve the ability to detect the presence or recurrence of disease.

PURPOSE: Diagnostic trial to detect melanoma markers in the lymph nodes or peripheral blood of patients who have melanoma.

Detailed Description

OBJECTIVES:

Determine the feasibility of performing reverse transcriptase-polymerase chain reaction (RT-PCR) for five different tumor antigen genes using lymph node samples or peripheral blood from patients with melanoma.
Determine the ability of PCR-positive lymph nodes or peripheral blood to predict relapse of disease in these patients.
Determine the correlation of positive PCR results from peripheral blood with disease stage.

OUTLINE: Lymph node biopsies or peripheral blood are obtained from patients. These specimens are examined by nested reverse transcriptase-polymerase chain reaction (RT-PCR) and analyzed for various tumor antigens.

Patients may choose to be told the results of this testing, but the results do not influence or change the planned therapy. Brief counseling is required to discuss the results and their potential implications.

Patients are followed for at least 2 years.

PROJECTED ACCRUAL: A total of 30 patients for the lymph node portion and 80 patients (20 per stage of disease) for the peripheral blood portion will be accrued for this study within 3 years.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Measure	Description	Time Frame
To determine if there is a suggestion that PCR-positive lymph nodes predict relapse of disease		3 years

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Clinically proven melanoma with indication to perform sentinel lymph node biopsy or elective lymph node dissection OR
Histologically proven or diagnosis highly suspicious for melanoma

PATIENT CHARACTERISTICS:

Age:

Any age

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Platelet count greater than 50,000/mm^3
Hemoglobin greater than 7 g/dL

Hepatic:

PT less than 15 sec
PTT less than 30 sec

Renal:

Not specified

Other:

No psychiatric illness that precludes compliance
No other concurrent malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Thomas F. Gajewski, MD, PhD	University of Chicago	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago Cancer Research Center		Chicago	Illinois	60637	United States

ID	Term
D008545	Melanoma

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Intervention Browse Module

MeSH Terms

ID	Term
D020133	Reverse Transcriptase Polymerase Chain Reaction
D021701	Sentinel Lymph Node Biopsy

Ancestor Terms

ID	Term
D016133	Polymerase Chain Reaction
D021141	Nucleic Acid Amplification Techniques
D005821	Genetic Techniques
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
UCCRC-9308
UCCRC-CTRC-9767
NCI-G99-1620

Name	Type	Description	Arm Group Labels	Other Names
reverse transcriptase-polymerase chain reaction	Genetic
sentinel lymph node biopsy	Procedure