A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies

Not yet recruiting

• Conditions: Acute Myeloid Leukaemia (AML)

• Registration Number: NCT07154823
• Lead Sponsor: Tempus AI

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-08-26
• Status Verified: 2025-09
• Study First Posted: 2025-09-04
• Last Update Submitted: 2025-09-25
• Last Update Posted: 2025-10-01
• Study Start: 2025-11-01
• Primary Completion: 2034-11
• Study Completion: 2035-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Willing and able to participate in the research and provide biospecimens (All Cohorts)
2. Willing and able to provide informed consent (All Cohorts)
3. Have documented diagnosis of AML according to the World Health Organization (WHO) classification (Cohort 001 Only)
4. Secondary AML is allowed (Cohort 001 Only)

Exclusion Criteria

1. Not willing or able to adhere with the study procedures (All Cohorts)
2. Have received any prior therapy intended for standard of care (SoC) treatment of AML (Cohort 001 Only)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess biomarker landscape in the progression as well as baseline biospecimen samples and correlate with with real-world outcomes across multiple hematologic indications.	5 years	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.