Clinical trial · Interventional
New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease
NCT07793006CI-TRIAL-00124595recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Persons living with HIV (PLWH) in sub-Saharan Africa (SSA), lymphadenopathy often portends one of a number of life-threatening diseases including tuberculosis, lymphoma, and multicentric Castleman disease (MCD). Overcoming these delays and missed diagnoses requires new approaches to identify lymphoma and MCD.
Conditions
Conditions (6)
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 | — |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease | — | UNRESOLVED | — |
| Lymphadenopathy | — | UNRESOLVED | — |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Tiny Isothermal Nucleic Acid Amplification System | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fine Needle Aspiration | Procedure | — | UNRESOLVED |
| Lymph Node or Core Needle Biopsy | Procedure | — | UNRESOLVED |
| Tiny Isothermal Nucleic acid Amplification System (TINY) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HIV-infected patients with unexplained lymphadenopathy
- description
- HIV-infected patients in routine clinical care with unexplained lymphadenopathy
- interventionNames
- Procedure: Lymph Node or Core Needle Biopsy
- Procedure: Fine Needle Aspiration
- Diagnostic Test: Tiny Isothermal Nucleic acid Amplification System (TINY)
Primary outcomes (1)
- measure
- Number of patients with diagnoses
- timeFrame
- Enrollment
- description
- Proportion of patients diagnosed with each of the following by histopathology and immunohistochemistry: tuberculosis, lymphoma, MCD, other diagnosis, or non-diagnostic.
Secondary outcomes (10)
- measure
- Baseline clinical and laboratory characteristics
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
Inclusion Criteria: * Age ≥1 year old and body weight of ≥ 10 kg. * HIV-infected. * Unexplained lymphadenopathy with at least one lymph node ≥2 cm that is amenable to biopsy. * Willing and able to give informed consent if the subject is 18 years of age or older, adolescent assent and legal guardian consent for subjects 15-17 years of age, pediatric assent and legal guardian consent for subjects 7-14 years of age, or legal guardian consent for pediatric subjects less than 7 years of age. Exclusion Criteria: * Cannot or is not willing to follow study procedures. * Subjects with a previous history of cancer in the last five years with the exception of subjects with Kaposi sarcoma (i.e. history of Kaposi sarcoma is allowed in the study).
References
Publications (0)
Data not yet available
No reference posted for this study.