Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433485
Status:
COMPLETED
Last Update Posted:
2016-09-23
First Post:
2007-02-08
Brief Title:
Topical Sirolimus in Patients With Basal Cell Nevus Syndrome and in Healthy Participants
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
In Vivo and In Vitro Pharmacology of Sirolimus in Subjects With Basal Cell Nevus Syndrome
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Studying samples of blood and tissue from patients with basal cell nevus syndrome and from healthy participants in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to basal cell nevus syndrome Chemoprevention is the use of certain drugs to keep cancer from forming growing or coming back The use of sirolimus may keep basal cell skin cancer from forming in patients with basal cell nevus syndrome
PURPOSE This phase I trial is studying topical sirolimus in patients with basal cell nevus syndrome and in healthy participants
PURPOSE This phase I trial is studying topical sirolimus in patients with basal cell nevus syndrome and in healthy participants
Detailed Description:
OBJECTIVES
Primary
Compare messenger RNA and protein expression patterns in patients with basal cell nevus syndrome BCNS vs in cultured cells of healthy participants control before treatment to identify a set of genes that are differentially expressed in BCNS
Assess the effects of topical sirolimus on gene expression genes identified in the primary objective in vivo using keratinocytes fibroblasts and lymphocytes from patients with BCNS and from healthy participants controls by targeted expression methods
OUTLINE Patients and healthy participants receive topical sirolimus ointment twice daily for 12 weeks
Blood and skin biopsies are obtained at baseline and at week 12 for gene and protein expression studies Alterations in RNA are measured by microarray analysis Alterations in protein expression are measured by 2-dimensional gel electrophoresis and matrix-assisted laser desorption ionization time-of-flight mass spectrometry
After completion of study therapy patients and healthy participants are followed at 4 weeks
PROJECTED ACCRUAL A total of 16 patients and healthy participants will be accrued for this study
Primary
Compare messenger RNA and protein expression patterns in patients with basal cell nevus syndrome BCNS vs in cultured cells of healthy participants control before treatment to identify a set of genes that are differentially expressed in BCNS
Assess the effects of topical sirolimus on gene expression genes identified in the primary objective in vivo using keratinocytes fibroblasts and lymphocytes from patients with BCNS and from healthy participants controls by targeted expression methods
OUTLINE Patients and healthy participants receive topical sirolimus ointment twice daily for 12 weeks
Blood and skin biopsies are obtained at baseline and at week 12 for gene and protein expression studies Alterations in RNA are measured by microarray analysis Alterations in protein expression are measured by 2-dimensional gel electrophoresis and matrix-assisted laser desorption ionization time-of-flight mass spectrometry
After completion of study therapy patients and healthy participants are followed at 4 weeks
PROJECTED ACCRUAL A total of 16 patients and healthy participants will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| YALE-HIC-26866 | None | None | None |