A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0+
SponsorTempus AI
About this trial
The TEMPUS AQUARIUS Study is a non-interventional, longitudinal observational study focused on hematological malignancies. It will collect rich molecular (multi-omic) and clinical data from patient cohorts through serial blood draws and the acquisition of leftover tissue and/or bone marrow aspirates during their routine therapy and disease monitoring. The primary goal is to understand the association between biomarkers and real-world clinical outcomes in these patient populations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to participate in the research and provide biospecimens
Willing and able to provide informed consent
Have documented diagnosis of AML according to the World Health Organization (WHO) classification
Secondary AML is allowed
Disqualifiers
002A: Received prior treatment for follicular lymphoma
002A: Diagnosed with High Risk follicular lymphoma by any of the following definitions: FLIPI High Risk, GELF High Tumor Burden, LDH above ULN
002A: Resected patients with NED
002B: Intended for active observation
Trial population
This study is intended to include multiple hematologic malignancies.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
None - Observational Study
Other interventionThere are no interventions in this observational study.
Treatment groups
550 Participants
are divided into 2 treatment groupsGroup A: Cohort 001: Newly Diagnosed Acute Myeloid Leukemia (AML)1 intervention
Group B: Cohort 002: Folicular Lymphoma1 intervention
Trial outcomes
Primary outcomes
1
To assess biomarker landscape in the progression as well as baseline biospecimen samples and correlate with with real-world outcomes across multiple hematologic indications.
The goal of this biomarker discovery registry is to assess DNA and RNA expression patterns and potential biomarkers in biospecimens collected at baseline and throughout treatment, with the goal of generating hypotheses about predictive markers for therapy selection, prognostic indicators, and potential mechanisms of resistance to standard-of-care therapies across multiple hematologic indications.
Time frame
5 years Source ClinicalTrials.gov