Upper AerodigestiveTract CancerMETABORLNCT07377084
Metabolomics of Cancers of the Upper Aerodigestive Tract
An observational study of Upper AerodigestiveTract Cancer, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
Metabolomics, thanks to advances in mass spectrometry, allows for the analysis of cellular metabolites to better understand biological processes. In oncology, it provides a global view of metabolic alterations in tumors and enables the classification of cancers based on various medical parameters using advanced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper AerodigestiveTract Cancer
- What is being tested?
- Blood samples for the analysis of sildenafil in plasma and urine samples
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2020to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes patients managed for a suspected upper aerodigestive tract tumor undergoing ENT panendoscopy with biopsies, with final inclusion limited to patients with histologically confirmed squamous cell carcinoma of the upper aerodigestive tract.
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Antoine Lacassagne
Nice
Dorsaf BENDJEBEL, 0033492031778, drci-promotion@nice.unicancer.fr
Alexandre BOZEC, MD
About this study
Metabolomics, thanks to advances in mass spectrometry, allows for the analysis of cellular metabolites to better understand biological processes. In oncology, it provides a global view of metabolic alterations in tumors and enables the classification of cancers based on various medical parameters using advanced statistical methods (machine learning). Its low cost and speed make it a promising approach in personalized medicine.
Cancers of the upper aerodigestive tract (UADT), the fifth most common cancer in France, are often diagnosed late, reducing survival chances (35-50% at five years). Identifying a specific metabolomic signature for these cancers could facilitate early detection, assess treatment response, and rapidly detect recurrences. Additionally, HPV-induced tumors may exhibit a distinct metabolic profile compared to those caused by tobacco and alcohol. Currently, no published studies have explored this topic for UADT cancers, highlighting the need for such research.
Read more
The aim of this study is to identify a metabolomic signature associated with the presence of UADT cancer at initial diagnosis and during post-therapeutic follow-up (three months after treatment completion). Hypothesis is that a specific metabolomic signature will be observed in the biological samples of patients diagnosed with UADT cancer, that the type of observed signature could be correlated with tumor site, stage, HPV status, and prognosis, and that the persistence or disappearance of this metabolomic signature three months after treatment may be associated with the risk of recurrence. The search for this potential metabolomic signature will be conducted using tumor biopsies, plasma, and urine samples at the initial diagnostic phase and plasma and urine samples at three and six months post-treatment follow-up.
Ultimately, the benefits of this study lie in improving early diagnosis, treatment (adjusting treatment based on the prognostic value of specific metabolomic signatures), and follow-up (early detection of recurrences, adapting monitoring to each patient's individual risk) of UADT cancers.
As the study is based on biological samples collected as part of standard patient care (with no additional biological tests or procedures performed specifically for research), no research-related risk is expected for the patient.
This is a prospective, single-center study involving patients with histologically confirmed, untreated squamous cell carcinoma of the UADT (oral cavity, oropharynx, larynx, and hypopharynx) who will receive curative treatment at the Antoine Lacassagne Center.
The search for a potential metabolomic signature will be conducted using biological and tumor samples collected as part of standard patient care, without requiring additional tests or procedures.
The primary objective of the study is to identify a metabolomic signature in patients with UADT cancer.
The secondary objectives of the study are:
- To investigate the correlation between a metabolomic signature and tumor characteristics.
- To examine the relationship between a metabolomic signature at three to six months post-treatment and oncological status at three to six months and one year post-treatment in patients with UADT cancer.
- Conditions
- Upper AerodigestiveTract Cancer
- Being tested
- Blood samples for the analysis of sildenafil in plasma, urine samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for the analysis of sildenafil in plasmaProcedure or surgery
blood samples collection at screening and between the 3rd and 6th month after the end of treatment.
urine samplesBiological
Urine samples collection at screening and between the 3rd and 6th month after the end of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Patients with upper aerodigestive tract tumor requiring a panendoscopy with biopsy | Not described Receives: Procedure: Blood samples for the analysis of sildenafil in plasma; Biological: urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the diagnostic performance (sensitivity/specificity) of the metabolomic signature in patients with UADT cancer.
Measured: At screening and between the 3rd and 6th month after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start4 Nov 2020
- Primary completionFeb 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper AerodigestiveTract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre BOZEC, MD, Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377084
- Sponsor's protocol ID
- 2020/14
- Acronym
- METABORL
- Status last verified
- Jan 2026
- First submitted
- 21 Feb 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics of Cancers of the Upper Aerodigestive Tract
- ClinicalTrials.gov ID
- NCT07377084
- Acronym / sponsor ID
- METABORL / 2020/14
- Conditions
- Upper AerodigestiveTract Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metabolomics, thanks to advances in mass spectrometry, allows for the analysis of cellular metabolites to better understand biological processes. In oncology, it provides a global view of metabolic alterations in tumors and enables the classification of cancers based on various medical parameters using advanced statistical methods (machine learning). Its low cost and speed make it a promising approach in personalized medicine.
Cancers of the upper aerodigestive tract (UADT), the fifth most common cancer in France, are often diagnosed late, reducing survival chances (35-50% at five years). Identifying a specific metabolomic signature for these cancers could facilitate early detection, assess treatment response, and rapidly detect recurrences. Additionally, HPV-induced tumors may exhibit a distinct metabolic profile compared to those caused by tobacco and alcohol. Currently, no published studies have explored this topic for UADT cancers, highlighting the need for such research.
The aim of this study is to identify a metabolomic signature associated with the presence of UADT cancer at initial diagnosis and during post-therapeutic follow-up (three months after treatment completion). Hypothesis is that a specific metabolomic signature will be observed in the biological samples of patients diagnosed with UADT cancer, that the type of observed signature could be correlated with tumor site, stage, HPV status, and prognosis, and that the persistence or disappearance of this metabolomic signature three months after treatment may be associated with the risk of recurrence. The search for this potential metabolomic signature will be conducted using tumor biopsies, plasma, and urine samples at the initial diagnostic phase and plasma and urine samples at three and six months post-treatment follow-up.
Ultimately, the benefits of this study lie in improving early diagnosis, treatment (adjusting treatment based on the prognostic value of specific metabolomic signatures), and follow-up (early detection of recurrences, adapting monitoring to each patient's individual risk) of UADT cancers.
As the study is based on biological samples collected as part of standard patient care (with no additional biological tests or procedures performed specifically for research), no research-related risk is expected for the patient.
This is a prospective, single-center study involving patients with histologically confirmed, untreated squamous cell carcinoma of the UADT (oral cavity, oropharynx, larynx, and hypopharynx) who will receive curative treatment at the Antoine Lacassagne Center.
The search for a potential metabolomic signature will be conducted using biological and tumor samples collected as part of standard patient care, without requiring additional tests or procedures.
The primary objective of the study is to identify a metabolomic signature in patients with UADT cancer.
The secondary objectives of the study are:
- To investigate the correlation between a metabolomic signature and tumor characteristics.
- To examine the relationship between a metabolomic signature at three to six months post-treatment and oncological status at three to six months and one year post-treatment in patients with UADT cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with upper aerodigestive tract tumor requiring a panendoscopy with biopsy | – | Procedure: Blood samples for the analysis of sildenafil in plasma, Biological: urine samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients managed for a suspected upper aerodigestive tract tumor undergoing ENT panendoscopy with biopsies, with final inclusion limited to patients with histologically confirmed squamous cell carcinoma of the upper aerodigestive tract.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for the analysis of sildenafil in plasmablood samples collection at screening and between the 3rd and 6th month after the end of treatment. | Procedure or surgery | Patients with upper aerodigestive tract tumor requiring a panendoscopy with biopsy |
| urine samplesUrine samples collection at screening and between the 3rd and 6th month after the end of treatment. | Biological | Patients with upper aerodigestive tract tumor requiring a panendoscopy with biopsy |
Primary outcome
The primary outcome measure is the diagnostic performance (sensitivity/specificity) of the metabolomic signature in patients with UADT cancer.
Time frame: At screening and between the 3rd and 6th month after the end of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandre BOZEC, MD principal investigator
Centre Antoine Lacassagne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper AerodigestiveTract Cancer, run by Centre Antoine Lacassagne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the diagnostic performance (sensitivity/specificity) of the metabolomic signature in patients with UADT cancer. (time frame: At screening and between the 3rd and 6th month after the end of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.