Study of Families With Melanoma

NCT00445783 | Unknown

• 3 other identifiers: CRUK-LCC-1/3/57CDR0000532934EU-20704
• Study Type: observational
• Target: 3,700
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: A study that evaluates patients' lifestyle, skin, and blood and tissue samples may help doctors understand the risk factors for melanoma relapse. PURPOSE: This clinical trial is studying the risk factors for melanoma in families with melanoma.

Conditions

Melanoma (Skin)

Keywords

lentigo maligna malignant melanoma; stage IV melanoma; acral lentiginous malignant melanoma; nodular malignant 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

Outcome Measures

Primary Outcomes (4)

• Lifestyle factors governing relapse from melanoma

• Genes governing relapse from melanoma

• Sun exposure and genes that cause melanoma

• Unusual moles related to sun exposure and genes that cause melanoma

Interventions

gene expression analysis GENETIC

mutation analysis GENETIC

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

examination PROCEDURE

mutation carrier screening PROCEDURE

study of high risk factors PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Newly diagnosed primary invasive melanoma (patient group) * Lentigo maligna malignant melanoma allowed * Rare variants of melanoma allowed, including any of the following: * Acral lentiginous * Subungual * Ear, nose, and throat * Oropharyngeal * Perineal * Vaginal * Vulval * Rectal * Nodal with no known primary * Patients undergoing sentinel node biopsy are eligible * No in situ melanoma, melanocytic intraepidermal neoplasia, or ocular melanoma * Healthy participant meeting either of the following criteria (control group): * Relative of a patient who was diagnosed with melanoma after September 2005 * Healthy volunteer who is age- and sex-matched for patients who were diagnosed with melanoma before October 2005 PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Leeds Cancer Centre at St. James's University Hospital: lead

Study Sites (1)

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Gene Expression Profiling; Immunohistochemistry; Restraint, Physical

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques; Behavior Control; Therapeutics; Immobilization

Study Officials

• Julia Newton Bishop, MD

  Leeds Cancer Centre at St. James's University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 9, 2007
• Study Start: July 1, 2000
• Primary Completion: December 1, 2020
• Last Updated: August 12, 2013

Record last verified: 2008-04

Locations

GB (1)