Cancer and Immune Cell Metabolism in Patients With Hematological Malignancies

NCT07189117 | Recruiting

• 1 other identifier: 2025-01775;th25Aposotolova
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates how metabolism in cancer and immune cells shapes the bone marrow environment, influences therapy resistance, and affects outcomes in hematological malignancies.

Conditions

Hematologic Malignancy

Keywords

allo-HSCT

Outcome Measures

Primary Outcomes (4)

• Concentration of metabolites

  the concentration of metabolites in malignant cells, immune cells, and extracellular fluid in each sample at the time point at which the sample is obtained. Metabolite and lipid concentrations will be measured by mass spectrometry.

  at primary diagnosis (month 0); after initial chemotherapy (month +0.5-2); before allo-HSCT (month +3-12); 1, 3, 6, 12 month after allo-HSCT (month 4-13, 6-15, 9-18, 15-24), and at relapse (if applicable, up to 5 years)

• Concentration of lipids

  the concentration of lipids in malignant cells, immune cells, and extracellular fluid in each sample at the time point at which the sample is obtained. Metabolite and lipid concentrations will be measured by mass spectrometry.

  at primary diagnosis (month 0); after initial chemotherapy (month +0.5-2); before allo-HSCT (month +3-12); 1, 3, 6, 12 month after allo-HSCT (month 4-13, 6-15, 9-18, 15-24), and at relapse (if applicable, up to 5 years)

• Expression profiling

  the expression of metabolite-related genes and proteins that will be measured by (single-cell) RNA-sequencing, quantitative polymerase chain reaction (PCR), proteomics, flow cytometry, western blotting, or another appropriate technique.

  at primary diagnosis (month 0); after initial chemotherapy (month +0.5-2); before allo-HSCT (month +3-12); 1, 3, 6, 12 month after allo-HSCT (month 4-13, 6-15, 9-18, 15-24), and at relapse (if applicable, up to 5 years)

• Metabolic function

  Metabolic function will be assessed by extracellular flux assays, flow cytometry, or another appropriate technique.

  at primary diagnosis (month 0); after initial chemotherapy (month +0.5-2); before allo-HSCT (month +3-12); 1, 3, 6, 12 month after allo-HSCT (month 4-13, 6-15, 9-18, 15-24), and at relapse (if applicable, up to 5 years)

Secondary Outcomes (4)

• Response to treatment(s)

  during whole study, up to 5 years after allo-HSCT

• Duration of the response

  during whole study, up to 5 years after allo-HSCT

• Progression-free survival

  during whole study, up to 5 years after allo-HSCT

• Overall survival

  during whole study, up to 5 years after allo-HSCT

Study Arms (2)

Participants with hematological cancers

Healthy stem cell donors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with hematological cancers: Adults (≥18 years) with MDS, AML, ALL, or primary/secondary myelofibrosis from whom blood and bone marrow samples will be collected during the disease course. Healthy donors: Adults (≥18 years) donating hematopoietic stem cells for allogeneic transplantation, providing peripheral blood or bone marrow samples as a source of healthy stem cells.

You may qualify if:

• age \> 18 years,
• signed written informed consent
• For participants with hematological cancers: diagnosis of MDS, AML, ALL, PMF or post-ET/PV MF

You may not qualify if:

• pregnant or lactating women,
• inability to give consent,
• For healthy donors: previous or current hematological disease, previous or current other malignant disease,

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood and Bone Marrow

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Petya Apostolova, Prof. Dr.

  University Hospital of Basel

  STUDY CHAIR

• Johannes Tossounidis, MD

  University Hospital of Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petya Apostolova, Prof. Dr.

CONTACT

+41 61 328 48 40; petya.apostolova@unibas.ch

Johannes Tossounidis, MD

CONTACT

johannes.tossounidis@unibas.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 23, 2025
• Study Start: October 29, 2025
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2040
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

CH (1)