Metabolite profiling for upper aerodigestive tract cancer
Metabolomics of Cancers of the Upper Aerodigestive Tract
This research will test whether blood and urine metabolite patterns can identify and characterize upper aerodigestive tract cancers in people with newly diagnosed, untreated squamous cell tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Antoine Lacassagne Academic / other |
| Locations | 1 site (Nice) |
| Trial ID | NCT07377084 on ClinicalTrials.gov |
What this trial studies
This observational project uses mass spectrometry-based metabolomics on blood and urine samples from patients with untreated squamous cell cancers of the oral cavity, oropharynx, larynx, or hypopharynx. Researchers will measure small-molecule metabolites and apply statistical and machine-learning methods to look for signatures that distinguish tumor types, HPV-related disease, and clinical features like stage or treatment response. No experimental treatment is given; participation involves sample collection and data use alongside planned curative care at Centre Antoine Lacassagne. Findings will be compared with clinical and pathological data to develop potential biomarkers for early detection, monitoring, and recurrence surveillance.
Who should consider this trial
Good fit: Adults with histologically confirmed, untreated squamous cell carcinoma of the upper aerodigestive tract (T1-4, N0-3, M0) who are planned for curative treatment at Centre Antoine Lacassagne and consent to provide blood and urine samples.
Not a fit: Patients with metastatic (M1) disease, those not eligible for curative treatment, or those unwilling to allow the use of their biological samples are unlikely to benefit from this research.
Why it matters
Potential benefit: If successful, this could lead to quick, low-cost blood or urine tests that help detect UADT cancers earlier and monitor treatment response or recurrence.
How similar studies have performed: Metabolomics has produced useful biomarkers in other cancer types, but no published metabolomic studies specific to upper aerodigestive tract cancers have been reported, so this application is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically proven squamous cell carcinoma of the upper aerodigestive tract (oral cavity, oropharynx, larynx, and hypopharynx), stage T1-4, N0-3, M0, untreated. * Curative treatment planned at CAL. * Patient who has voluntarily consented to the use of their data and signed a non-opposition form for the use of their biological and tumor samples. Exclusion Criteria: * Metastatic patient (M1). * No curative treatment possible. * History of cancer (other than basal cell carcinoma) in the last 5 years. * Tumor size deemed insufficient according to the assessment of the ENT surgeon. * Patient refusal to allow the use of their biological and tumor samples for research. * Vulnerable persons are defined in articles L1121-5 to -8: * Pregnant women, women in labor, and nursing mothers, individuals deprived of liberty by a judicial or administrative decision, individuals hospitalized without consent under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of article L. 1121-8, * And individuals admitted to a health or social establishment for purposes other than research, * Adults under legal protection or unable to express their non-opposition.
Where this trial is running
Nice
- Centre Antoine Lacassagne — Nice, France (Recruiting)
Study contacts
- Principal investigator: Alexandre BOZEC, MD — Centre Antoine Lacassagne
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.