MedDataX Logo

Studying Tumor Tissue Samples From Patients With Melanoma Who Have Undergone Sentinel Lymph Node Biopsy

NCT ID: NCT00897481

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future.

PURPOSE: This laboratory study is looking at tumor tissue samples from patients with melanoma who have undergone sentinel lymph node biopsy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES:

* Develop a predictive model for sentinel lymph node biopsy positivity in patients with melanoma who have undergone sentinel lymph node biopsy.
* Develop a survival model for relapse based on sentinel lymph node biopsy positivity.
* Assess the genetic determinants in primary melanomas that predict a metastatic phenotype and thereby improve understanding of the biology of the metastases in melanoma.

OUTLINE: This is a retrospective, case-controlled, multicenter study. Patients are stratified according to Breslow thickness of the tumor (0.75-1.50 mm vs 1.51- 4 mm vs \> 4 mm) and gender.

Archived tumor tissue is analyzed by immunohistochemistry (IHC) for AP2, vascular endothelial growth factor, MMP 2, MCM4, and others, if feasible. Sentinel node biopsies are analyzed by IHC for CD31, LYVE-1, and D2-40 expression. RNA and DNA are also extracted for genetic expression studies and mutation analysis (e.g., BRAF, NRAS, PTEN, CDKN2A).

Patient data related to relapse and recurrence is collected, if available.

Peer reviewed and funded or endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Melanoma (Skin)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

stage IV melanoma recurrent melanoma stage IA melanoma stage IB melanoma stage IIA melanoma stage IIB melanoma stage IIC melanoma stage IIIA melanoma stage IIIB melanoma stage IIIC melanoma

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

gene expression analysis

Intervention Type GENETIC

mutation analysis

Intervention Type GENETIC

diagnostic laboratory biomarker analysis

Intervention Type OTHER

immunohistochemistry staining method

Intervention Type OTHER

sentinel lymph node biopsy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

DISEASE CHARACTERISTICS:

* Confirmed diagnosis of cutaneous melanoma

* Breslow thickness \> 0.75 mm
* Has undergone sentinel lymph node biopsy
* No primary melanoma that has not originated in the skin
* No multiple primary melanomas
* Currently under clinical followup OR discharged from follow up within the past 3 months

PATIENT CHARACTERISTICS:

* No other malignancy except for nonmelanoma skin cancer or cervical carcinoma in situ

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Leeds Cancer Centre at St. James's University Hospital

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julia Newton Bishop, MD

Role: STUDY_CHAIR

Leeds Cancer Centre at St. James's University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Julia Newton Bishop, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CDR0000532943

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU-20706

Identifier Type: -

Identifier Source: secondary_id

CRUK-LCC-06/Q1206/149

Identifier Type: -

Identifier Source: org_study_id