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
Recruitment status was Recruiting
Sponsor:
Hadassah Medical Organization
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01167998
First received: July 21, 2010
Last updated: August 3, 2011
Last verified: July 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 21, 2010 | ||||
| Last Updated Date | August 3, 2011 | ||||
| Start Date ICMJE | July 2010 | ||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01167998 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Early Diagnosis of Malignant Transformation of Pigmentary Skin Lesions | ||||
| Official Title ICMJE | Early Diagnosis of Malignant Melanoma Transformation in Pigmentary Skin Lesions | ||||
| Brief Summary | 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Healthy individuals above 18 years of age with pignented skin lesions indicated for excision |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01167998 | ||||
| Other Study ID Numbers ICMJE | orlucent-HMO-CTIL | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Catherine Shachaf, Orlucent Inc | ||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Hadassah Medical Organization | ||||
| Verification Date | July 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||