NCT07154823 A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies
| NCT ID | NCT07154823 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tempus AI |
| Condition | Acute Myeloid Leukaemia (AML) |
| Study Type | OBSERVATIONAL |
| Enrollment | 550 participants |
| Start Date | 2026-01-27 |
| Primary Completion | 2034-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 550 participants in total. It began in 2026-01-27 with a primary completion date of 2034-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
All Cohorts Inclusion Criteria: 1. Willing and able to participate in the research and provide biospecimens 2. Willing and able to provide informed consent Cohort 001 Inclusion: 1. Have documented diagnosis of AML according to the World Health Organization (WHO) classification 2. Secondary AML is allowed Cohort 002 Inclusion: 1. Histologically confirmed diagnosis of Follicular Lymphoma (Subgroups A-D) 2. Submission of baseline sample representative of current disease per laboratory manual (Subgroups A-D) 3. 002A (Newly Diagnosed Active Observation): On active observation for 6 more or less, or intended for active observation 4. 002B (Newly Diagnosed, High Risk): Intended for first line treatment 5. 002B (Newly Diagnosed, High Risk): Meets the criteria for high risk by any of the following: Follicular Lymphoma Inernational Prognostic Index (FLIPI) High Risk, Groupe d'Etude des Lymphomes Follicularies (GELF) High Tumor Burden, Lactate Dehydrogenase (LDH) above the upper limit of normal (ULN) 6. 002C (Relapsed / Refractory High Risk POD24 FL): Documented progression of disease within 24 months (POD24) of first line follicular lymphoma treatment, prior to second line treatment 7. 002D (Transformed FL): Pathologically confirmed transformation All Cohorts Exclusion Criteria: 1\. Not willing or able to adhere with the study procedures Cohort 001: 1\. Have received any prior therapy intended for standard of care (SoC) treatment of AML Cohort 002: 1. 002A: Received prior treatment for follicular lymphoma 2. 002A: Diagnosed with High Risk follicular lymphoma by any of the following definitions: FLIPI High Risk, GELF High Tumor Burden, LDH above ULN 3. 002A: Resected patients with NED 4. 002B: Intended for active observation 5. 002B: Received prior treatment for follicular lymphoma
Contact & Investigator
Michael Thompson, MD, PhD, FASCO
PRINCIPAL INVESTIGATOR
Tempus AI
Frequently Asked Questions
Who can join the NCT07154823 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, studying Acute Myeloid Leukaemia (AML). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07154823 currently recruiting?
Yes, NCT07154823 is actively recruiting participants. Contact the research team at aquarius@tempus.com for enrollment information.
Where is the NCT07154823 trial being conducted?
This trial is being conducted at Iowa City, United States, Bethesda, United States, St Louis, United States, Reno, United States and 5 additional locations.
Who is sponsoring the NCT07154823 clinical trial?
NCT07154823 is sponsored by Tempus AI. The principal investigator is Michael Thompson, MD, PhD, FASCO at Tempus AI. The trial plans to enroll 550 participants.