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Not yet recruitingNCT07848061FoMe-LAMUpdated Sep 29, 2026

A Master Regulator of Lipid-Associated Macrophage Function in Cancer

An observational study in Breast Cancer and Head & Neck Cancer, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study summary

Cancer progression is shaped not only by genetic alterations but also by systemic and local metabolic changes that influence the tumor microenvironment (TME). In particular, dysregulated lipid metabolism and micronutrient availability can modulate immune cell function and favor the accumulation of immunosuppressive myeloid populations associated with tumor growth, immune evasion, and poor clinical outcome.

Among tumor-infiltrating myeloid cells, macrophages show high metabolic plasticity and adapt their phenotype in response to environmental cues. A subset of macrophages characterized by intracellular lipid accumulation and expression of lipid metabolism-related genes, known as lipid-associated macrophages (LAMs), has been identified in metabolic disorders and, more recently, in several solid tumors, including breast, prostate, and head and neck cancers. In cancer, LAMs are generally associated with immunosuppressive functions, impaired anti-tumor immunity, extracellular matrix remodeling, tumor cell survival, and unfavorable prognosis. Their accumulation may reflect both local metabolic alterations within the TME and systemic metabolic dysregulation, such as obesity and altered lipid homeostasis. However, the factors regulating LAM differentiation and function in human cancers remain poorly defined.

Folate is an essential micronutrient involved in DNA synthesis, repair, methylation, and cellular metabolism. Folate deficiency is frequently observed in metabolic disorders, including obesity, and has also been reported in patients with advanced malignancies. Although epidemiological studies have linked folate status to cancer risk, progression, and mortality, results vary across tumor types and populations. Emerging evidence suggests that folate availability may influence lipid metabolism and immune cell differentiation, potentially affecting macrophage polarization within tumors. Experimental studies indicate that folate depletion can alter fatty acid metabolism and promote lipid accumulation in different cell types. Moreover, folate uptake by macrophages is polarization-dependent, and folate receptor beta is selectively expressed by M2-like, immunosuppressive tumor-associated macrophages, supporting a possible link between folate metabolism and macrophage phenotype.

Altered folate metabolism may therefore contribute to macrophage metabolic reprogramming toward lipid-associated and immunosuppressive states in the TME. Since diet and micronutrient availability are increasingly recognized as modulators of anti-cancer immune responses, understanding the relationship between folate status, lipid metabolism, and LAMs in cancer patients may provide relevant mechanistic and prognostic insights. Given the limited human data available, an observational study using biological samples collected during routine clinical care represents an appropriate approach to investigate these associations without exposing participants to additional risks.

02

Conditions studied

  • Breast Cancer
  • Head & Neck Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients diagnosed with solid tumors who are undergoing standard diagnostic or therapeutic procedures. In details, cancer patients affected by Head and Neck Squamous Cell Carcinoma and Brest cancer, who underwent surgical resection at the Policlinic Agostino Gemelli (Fondazione Policlinico Universitario "Agostino Gemelli". - I.R.C.C.S.).

Inclusion criteria

  • Adult cancer patients with ≥ 18 years.
  • Patients who will agree to take part to the study and signed informed consent.
  • Availability of clinicopathological record.
  • Patients diagnosed by Head and Neck Squamous Cell Carcinoma that underwent surgery.
  • Patients diagnosed by and Brest cancer that underwent surgery.

Exclusion criteria

Exclusion Criteria:

  • Inability or unwillingness to provide informed consent.
  • Patients with ≤18 years.
  • Incomplete clinical data.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Association between folate levels and lipid metabolic alterations

    To investigate the association between folate levels and lipid metabolic alterations in immune cells, specifically on macrophages, and biological samples obtained from both head and neck and breast cancer patients.

    Time frame: 5 years

Secondary outcomes

  1. Immune cell phenotypes/macrophagesand folate status

    To characterize immune cell phenotypes/macrophages associated with different folate status levels.

    Time frame: 5 years

  2. Clinical features and folate/lipid metabolism

    To explore correlations between folate levels, lipid metabolism parameters, and clinical characteristics of disease severity.

    Time frame: 5 years

06

Study locations

1 site
  • Fondazione Policlinico Universitario A. Gemelli IRCCS
    Roma, 00168, Italy
07

Registry details

Key details

Study ID
NCT07848061
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
Sep 29, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Oct 1, 2031 (estimated)
Completion
Mar 31, 2032 (estimated)
Last update
Sep 29, 2026

Study contacts

Gianluca Franceschini
Contact
gianluca.franceschini@policlinicogemelli.it
+39 0630151
Eleonora Timperi
Contact
eleonora.timperi@unicatt.it
Gianluca Franceschini
principal investigator · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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