Clinical trial · Observational
Investigating Chemotherapy Treatments, Response and Subsets of HIV-associated Kaposi Sarcoma in Malawi
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to identify important associations between complete and comprehensive clinical, laboratory, and genomic data derived from patients and tumor specimens, with prospectively recorded clinical outcomes. The investigators also hope to move beyond simple risk factor associations as previously described, to develop a composite score specifically for KS recurrence or progression, analogous to widely used risk scores that are used to direct up-front treatment of other cancers. In so doing, the investigators will draw on extremely granular data to prospectively identify patients who are most likely to benefit from new treatments.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV | — | UNRESOLVED | — |
| Kaposi Sarcoma | Kaposi Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Estimate the complete response rate (CR) at 48 weeks of HIV-associated KS patients overall and by BV treatment group.
- timeFrame
- 48 weeks
- description
- the assessment of a patient's response (CR) to chemotherapy at 48 weeks by ACTG criteria
Secondary outcomes (2)
- measure
- Estimate the Progression Free Survival (PFS) in HIV-associated KS patients overall and by bleomycin-vincristine (BV) treatment group
- timeFrame
- 48 weeks
- description
- PFS which will be defined as the time from treatment initiation until disease progression or death
- measure
- Estimate OS in HIV-associated KS patients overall and by BV treatment group
- timeFrame
- 48 weeks
- description
- To estimate OS in HIV-associated KS patients overall and by BV treatment group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed KS initiating chemotherapy at Lighthouse Trust or the Kamuzu Central Hospital (KCH) Cancer Clinic * HIV positive (confirmed at any time point prior by local standard of care assay) on or off ART * Age ≥18 years * Residence \<200 kilometers from KCH * Able to understand and comply with study procedures for the entire length of the study * Subject able to understand and provide written consent in English or Chichewa Informed consent reviewed and signed by patient Exclusion Criteria: * Failure to meet inclusion criteria listed above. * Specifically, pregnancy and breastfeeding are not exclusion criteria given the observational nature of the study with diagnostic and treatment interventions administered according to local standards of care. * KS relapse disease as defined by a prior KS diagnosis within 1 year prior to enrollment.
References
Publications (0)
Data not yet available