Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06644079
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Window of Opportunity Study of Topical Tranexamic Acid for Cutaneous Squamous Cell Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Window of Opportunity Pilot Study of Topical Tranexamic Acid for Cutaneous Squamous Cell Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tranexamic Acid TXA is a safe and effective antifibrinolytic drug used systemically to control bleeding and topically to treat melasma and rosacea TXA suppresses the viability of multiple humanmurine cancer cell lines and Plasmin formation which prevents cleavage of the CDCP1 protein to a more oncogenic form TXA appears to act through additional anticancer mechanisms that include reduction of S6K1 and STAT3 phosphorylation on sites required for their activation
Uptake by cancer results in blockade of protein synthesis and alter signaling through the amino acid-sensitive mTORC1S6K1 and GCN2eiF2aATF4 pathways This is expected to induce autophagy which may mediate some of the biological effects of TXA on cells This effect of TXA is expected to be most prominent in cells that rely on high levels of basal protein synthesis such as cancer cells Currently no clinical treatment in this space to spare or improve surgical outcomes
Positive results could help reduce tumor size and suppress new cancer cell production before surgical interventions are taken This treatment could improve the outcomes and treatments of people with skin cancer If this window study is successful further studies will focus on patients with unresectable disease or those with lesions in areas difficult for surgical intervention
Uptake by cancer results in blockade of protein synthesis and alter signaling through the amino acid-sensitive mTORC1S6K1 and GCN2eiF2aATF4 pathways This is expected to induce autophagy which may mediate some of the biological effects of TXA on cells This effect of TXA is expected to be most prominent in cells that rely on high levels of basal protein synthesis such as cancer cells Currently no clinical treatment in this space to spare or improve surgical outcomes
Positive results could help reduce tumor size and suppress new cancer cell production before surgical interventions are taken This treatment could improve the outcomes and treatments of people with skin cancer If this window study is successful further studies will focus on patients with unresectable disease or those with lesions in areas difficult for surgical intervention
Detailed Description:
None
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