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Early Diagnosis of Malignant Transformation of Pigmentary Skin Lesions

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01167998
First received: July 21, 2010
Last updated: February 22, 2017
Last verified: February 2017
  Purpose
Malignant Melanoma is a deadly skin cancer that can be cured if diagnosed early. To date atypical pigmented skin lesions are diagnosed by appearance alone and many moles and lesions are excised unnecessarily and on the other hand malignant lesions are missed and diagnosed too late. In this study a protein conjugated to a florescent dye is spread on a suspicious pigmented lesion, the hypothesis is that this protein binds to malignant cells only and thus with a special camera that picks up the dye we can find pigmented lesions with early malignant transformation.

Condition
Malignant Melanoma Pigmented Nevi Skin Neoplasm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Diagnosis of Malignant Melanoma Transformation in Pigmentary Skin Lesions

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Enrollment: 20
Study Start Date: July 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy individuals above 18 years of age with pignented skin lesions indicated for excision
Criteria

Inclusion Criteria:

  • pigmented lesion indicated for surgical excision
  • over 18 years of age

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167998

Locations
Israel
: Hadassah Medical Organization,
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01167998     History of Changes
Other Study ID Numbers: orlucent-HMO-CTIL
Study First Received: July 21, 2010
Last Updated: February 22, 2017

Additional relevant MeSH terms:
Melanoma
Skin Neoplasms
Nevus, Pigmented
Nevus
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on September 21, 2017