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Early Diagnosis of Malignant Transformation of Pigmentary Skin Lesions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01167998
First received: July 21, 2010
Last updated: August 3, 2011
Last verified: July 2010
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 50
Study Start Date: July 2010
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167998

Contacts
Contact: Sharon Merims, MD 972-2-6777745 msharon@hadassah.org.il

Locations
Israel
: Hadassah Medical Organization, Recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD     : 00 972 2 6776095     arik@hadassah.org.il    
Contact: Hadas Lemberg, PhD     : 00 972 2 6777572     lhadas@hadassah.org.il    
Principal Investigator: Sharon Merims, MD            
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Catherine Shachaf, Orlucent Inc
ClinicalTrials.gov Identifier: NCT01167998     History of Changes
Other Study ID Numbers: orlucent-HMO-CTIL
Study First Received: July 21, 2010
Last Updated: August 3, 2011
Health Authority: israel : Ministry of Health - Director General

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

ClinicalTrials.gov processed this record on May 16, 2013