CancerALCINA 5NCT07060950
Analysis of Circulating Tumor Markers in Blood - ALCINA 5
A study testing Blood sampling C1 in people with Cancer and Lung Cancer, Non-Small Cell, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Lung Cancer, Non-Small Cell
- What is being tested?
- Blood sampling C1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2025to Jul 2035
- Phase
- Interventional
- 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
Who may be able to join
- Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,
- 18 years old or higher ?
- Patient who has provided informed, written, and explicit consent,
- Patient affiliated with a French Social Protection System.
- In the case of a tumor biopsy:
- Tumor considered as accessible by biopsy,
- Normal hemostasis assessment (PT, APTT, platelets),
- No anticoagulant or antiaggregant treatment for the biopsy.
Who cannot join
- Pregnant woman and/or breast-feeding,
- Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
- Private persons of freedom or under guardianship,
- Patient with a history of other invasive cancers within the 5 years preceding inclusion.
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 Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Marc Ychou, MD, PhD, 467613066 ext. +33, marc.ychou@icm.unicancer.fr
Aurore MOUSSION, 467613102 ext. +33, aurore.moussion@icm.unicancer.fr
About this study
The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process. In the multiplicity of these blood potential biomarkers joins a permanent evolution of the technological means used to detect them/to quantify, as well as to estimate their clinical utility.
Read the detailed description
The new major challenge in research focuses on the rapid evaluation of circulating biomarker candidates, which could replace or complement molecular analyses of tumor tissue obtained through biopsy (for example the search for somatic mutations of cancer) by a simple blood test (liquid biopsy). The other current important challenge is to have an idea of the interest to analyse the kinetics of blood markers, in particular in answer to a clinical "event", either through the chemotherapy, a biopsy and / or surgery. There is almost no data in the literature on this aspect. It is very likely that the liberation in the blood of the blood tumoral markers is strongly dependent on medical interventions on the tumour.
The study ALCINA 5 relies exactly on the principle of small cohorts based on the analysis of circulating tumour biomarkers obtained by blood sampling, with comparison - if necessary - with tumour material obtained by biopsy. Which cohort correspond each to a clinical situation and/or a technique of different implemented detection. In case of success, statistical hypotheses will be necessary for the implementation of wider studies (being then the object of a specific approval by competent authorities).
- Conditions
- Cancer, Lung Cancer, Non-Small Cell
- Being tested
- Blood sampling C1
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling C1Biological
Blood samples will be collected at four key time points :
- baseline (T1),
- first scan assessment (T2),
- second scan assessment (T3),
- and progression (T4).
| Study group | Role | What they receive |
|---|---|---|
| COHORT 1 - CURE | Other | Patients with histologically proven metastatic non-small cell lung carcinoma eligible for immunotherapy Receives: Biological: Blood sampling C1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cohorts : Study of the feasibility of detecting and/or analysing blood or tissue tumour biomarkers.
Success rate of the detection technique used (the criterion will be detailed according to the biomarker evaluated, in each of the cohorts)
Measured: 10 years
Secondary outcomes (1)
COHORT 1 - CURE : to define a liquid biopsy signature for predicting therapeutic response from samples taken before initiation of immunotherapy (T1).
CTCs-PD-L1+/-, ctDNA, circulating proteins (CPs) and circulating immune cells (CICs) will be measured in accordance with the definitions established in T1.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start26 Sep 2025
- Primary completionJul 2030 (estimated)
- Study completionJul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional study (blood collections and possibly tumor sample collection depending on cohort type) on single group cohorts (each cohort is defined in the arms below).
- Masking
- None (open label)
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060950
- Sponsor's protocol ID
- PROICM 2022-02 ALC
- Acronym
- ALCINA 5
- Status last verified
- Nov 2026
- First submitted
- 2 Jul 2025
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Circulating Tumor Markers in Blood - ALCINA 5
- ClinicalTrials.gov ID
- NCT07060950
- Acronym / sponsor ID
- ALCINA 5 / PROICM 2022-02 ALC
- Conditions
- Cancer, Lung Cancer, Non-Small Cell
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2035 (estimated)
- First posted
- 11 Jul 2025 (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.
The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process. In the multiplicity of these blood potential biomarkers joins a permanent evolution of the technological means used to detect them/to quantify, as well as to estimate their clinical utility.
Detailed description
The new major challenge in research focuses on the rapid evaluation of circulating biomarker candidates, which could replace or complement molecular analyses of tumor tissue obtained through biopsy (for example the search for somatic mutations of cancer) by a simple blood test (liquid biopsy). The other current important challenge is to have an idea of the interest to analyse the kinetics of blood markers, in particular in answer to a clinical "event", either through the chemotherapy, a biopsy and / or surgery. There is almost no data in the literature on this aspect. It is very likely that the liberation in the blood of the blood tumoral markers is strongly dependent on medical interventions on the tumour.
The study ALCINA 5 relies exactly on the principle of small cohorts based on the analysis of circulating tumour biomarkers obtained by blood sampling, with comparison - if necessary - with tumour material obtained by biopsy. Which cohort correspond each to a clinical situation and/or a technique of different implemented detection. In case of success, statistical hypotheses will be necessary for the implementation of wider studies (being then the object of a specific approval by competent authorities).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional study (blood collections and possibly tumor sample collection depending on cohort type) on single group cohorts (each cohort is defined in the arms below).
| Arm | Type | Receives |
|---|---|---|
| COHORT 1 - CURE | Other | Biological: Blood sampling C1Patients with histologically proven metastatic non-small cell lung carcinoma eligible for immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,
- 18 years old or higher ?
- Patient who has provided informed, written, and explicit consent,
- Patient affiliated with a French Social Protection System.
- Tumor considered as accessible by biopsy,
Key exclusion criteria (4 listed)
- Pregnant woman and/or breast-feeding,
- Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
- Private persons of freedom or under guardianship,
- Patient with a history of other invasive cancers within the 5 years preceding inclusion.
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 sampling C1Blood samples will be collected at four key time points : * baseline (T1), * first scan assessment (T2), * second scan assessment (T3), * and progression (T4). | Biological | COHORT 1 - CURE |
Primary outcome
All Cohorts : Study of the feasibility of detecting and/or analysing blood or tissue tumour biomarkers.
Time frame: 10 years
Success rate of the detection technique used (the criterion will be detailed according to the biomarker evaluated, in each of the cohorts)
1 secondary outcome
COHORT 1 - CURE : to define a liquid biopsy signature for predicting therapeutic response from samples taken before initiation of immunotherapy (T1).
Time frame: 4 years
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 6 Nov 2026.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling C1 in people with Cancer and Lung Cancer, Non-Small Cell, run by Institut du Cancer de Montpellier - Val d'Aurelle 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 8 inclusion and 4 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 6 Nov 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?
Contact Emmanuelle TEXIER (467613102 ext. +33, emmanuelle.texier@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All Cohorts : Study of the feasibility of detecting and/or analysing blood or tissue tumour biomarkers. (time frame: 10 years). 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 6 Nov 2026.