New Approaches for the Diagnosis of Lymphoma and Multicentric Castleman Disease
Recruiting · NCT07793006 · Interventional (participants receive a specific treatment) · Lead sponsor: Indiana University
View the official record on ClinicalTrials.gov →Interventions studied
Fine Needle AspirationLymph Node or Core Needle BiopsyTiny Isothermal Nucleic acid Amplification System (TINY)
What this trial is about
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.
Who can take part
Age range
1 Year and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
1 location listed.
- Lighthouse Trust HIV Centers of Excellence - Lilongwe, Malawi