Ignite Creation Date:
2024-07-17 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480773
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-24
Brief Title:
Kaposi Sarcoma Chemotherapy and Research KS-CARE
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Kaposi Sarcoma Chemotherapy and Research KS-CARE Clinical and Molecular Determinants of HIV-associated Kaposi Sarcoma Progression Under Local Standard-of-care Therapy in South Africa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
KS-CARE
Brief Summary:
This prospective nonrandomized open-label single-arm cohort study examines the effects of chemotherapy provided under local standard of care in patients with pathologically confirmed HIV-associated Kaposi Sarcoma HIV-KS Previous HIV-KS studies demonstrated significant variability in clinical outcomes based on differences in gender or baseline KSHV DNA levels in patients with HIV-KS
Patients will receive chemotherapy according to local site treatment guidelines and standard of care Chemotherapy regimen for two treatments that are used locally based on physicians choice namely intravenous IV Paclitaxel PTX or the combination of Bleomycin and Vincristine BV In addition all histologically proven HIV-KS could be enrolled irrespective of their prior length of combination anti-retroviral treatment cART This enrolment strategy will reflect a more realistic picture of HIV-KS management
This study result could trigger treatment alteration of HIV-KS The treatment approaches to HIV-KS can be individualized if clinically relevant subsets and novel prognostic markers are defined In that case newer and potentially more expensive agents can be selectively applied to those patients most likely to benefit especially if prolonged treatment is needed
Patients will receive chemotherapy according to local site treatment guidelines and standard of care Chemotherapy regimen for two treatments that are used locally based on physicians choice namely intravenous IV Paclitaxel PTX or the combination of Bleomycin and Vincristine BV In addition all histologically proven HIV-KS could be enrolled irrespective of their prior length of combination anti-retroviral treatment cART This enrolment strategy will reflect a more realistic picture of HIV-KS management
This study result could trigger treatment alteration of HIV-KS The treatment approaches to HIV-KS can be individualized if clinically relevant subsets and novel prognostic markers are defined In that case newer and potentially more expensive agents can be selectively applied to those patients most likely to benefit especially if prolonged treatment is needed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U54CA354640 | OTHER_GRANT | None | None |